CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH)

CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH) STANDARD OPERATING PROCEDURE (SOP) FOR RESOLUTION OF INTERNAL DIFFERENCES OF OPINION IN REGULATORY DECISION-MAKING TABLE OF CONTENTS: 1. Purpose 2. Background 3. Overview 3.1 General Policy 3.2 Procedural Summary 4. Definitions 4.1. Administrative File 4.2. Appealing Party 4.3. Concurrence 4.4. Eligible Difference of Opinion 4.5. Initiator 4.6. Joint Memorandum 4.7. Manager 4.8. Relevant Resource 4.9. Resolution 4.10. Scientific Evidence 4.11. Special Government Employee Homework Assignment 5. Requirements for Administrative Files 6. Procedures 6.1. Development of Conclusions and Recommendations 6.2. Differences of Opinion Between Peers in a Single Office 6.3. Differences of Opinion Between Peers in Two or More Offices 6.4. Difference of Opinion Between Managers and Employees 6.5. Appeals 6.6. Expedited Review of Internal Differences of Opinion 6.7. Treatment of Related Regulatory Work During On-going Resolution of Internal Differences of Opinion 7. Responsibilities 7.1. Authors 7.2. Initiators 7.3. Managers 7.4. Appealing Parties 7.5. Office Directors 7.6. Center Director 7.7. Ad Hoc Review Committee Members 7.8. CDRH Ombudsman 1

1. PURPOSE The purpose of this document is: (1) to set forth the general policy of the Center for Devices and Radiological Health (CDRH) with respect to internal differences of opinion related to regulatory decisions; (2) to explain the Center s Standard Operating Procedure (SOP) for resolving internal differences of opinion; and (3) to define the roles and responsibilities of Center staff in this process. 1 2. BACKGROUND When any regulatory decision is considered, CDRH should reach an institutional position. The process of coming to such a position is complex and may involve input from multiple staff members within one or more organizational components of the Center. Individual staff members are encouraged to share their views openly with others involved in the regulatory decisionmaking process. Given the multilayered nature of this work and the diversity of CDRH staff, it is expected that differences of opinion will occasionally arise. Differences of opinion may be scientific in nature (related to the interpretation of scientific evidence that serves as the basis for a decision), non-scientific (related to the interpretation or application of law or policy), or a combination of the two, such as decisions regarding the approval or clearance of a medical device. CDRH s regulatory decision-making process is designed to allow a variety of perspectives to be considered during the development of regulatory decisions. The process provides many opportunities to discuss differing opinions, such as meetings among review team members, meetings with managers within the Center and the Agency, meetings with sponsors, regulatory briefings, and Advisory Committee meetings. Open and respectful discussions enhance the quality of Center decisions. In most cases, staff can resolve their differences of opinion through discussion. Sometimes, however, staff members involved in the decision-making process are unable to reach agreement through discussion. In such cases, it is important to have a clear mechanism in place to allow for staff members views to be recorded and fully considered. Public health considerations, legislative mandates, regulations, and other commitments make it important to address internal differences of opinion in a timely manner so that final regulatory decisions can be made. It is equally important that the process for resolving internal differences of opinion and coming to final regulatory decisions be robust, fair, and transparent. 1 This SOP revises and supersedes an Office of Device Evaluation (ODE) Blue Book Memorandum on Documentation and Resolution of Differences of Opinion on Product Evaluations (G93-1) that was issued on December 23, 1993 and updated on May 28, 1996. The Blue Book Memorandum applied only to disagreements arising during product evaluation processes in the Office of Device Evaluation (ODE). This SOP enlarges the scope of that document and covers all Offices in CDRH that participate in the regulatory decision-making process. It also addresses, more specifically, disagreements between peers and the possibility for expedited review of internal disagreements. 2

3. OVERVIEW 3.1 General Policy It is the policy of CDRH to maintain a working environment that encourages staff members to make known their best professional judgments, even when they differ from a prevailing staff view, disagree with a management decision or policy position, or take issue with proposed or established practices. Managers should create an atmosphere of openness, trust, and respect for all individuals views. CDRH is committed to the protection of staff members from retaliation in any form for expressing differing opinions. It is the responsibility of all staff involved in a decision to ensure that staff members who express differing opinions are protected from retaliation by their peers, managers, Center leadership, and others. Concerns and complaints about retaliation or any other inappropriate responses to differences of opinion should be reported to the CDRH Ombudsman. This document does not supersede the fundamental protections provided by the Whistleblower Protection Act of 1989, the Federal Employee Anti-discrimination and Retaliation (No FEAR) Act of 2002, and all applicable federal laws, regulations, and Executive Orders that afford protection under the law. In the process of coming to a regulatory decision, differences of opinion may arise between staff members. The professional views of all staff members involved should be respected throughout the decision-making process. When differences of opinion arise, staff members should make an effort to come to a mutually acceptable regulatory decision through open and respectful discussion. In some cases, staff members may not be able to reach a mutually acceptable decision through discussion. It is the policy of CDRH to allow for supervisory review of a matter subject to unresolved internal disagreement, and to ensure that staff members are given the opportunity to record differing opinions and have them considered by higher-level managers. 3.2 Procedural Summary FDA s Administrative Practices and Procedures Regulation, 21 CFR 10.75(a)(1), provides for supervisory review of an employee s decision on a matter at the request of the employee. This document describes CDRH s implementation of 21 CFR 10.75(a)(1) as it applies to supervisory review of Center regulatory decisions on the initiative of employees involved in those decisions. The procedure described in this document does not cover other applications of the regulation. As described further in the remainder of this document, if a Center staff member believes it is necessary to pursue higher-level consideration of a regulatory decision, that staff member should document his or her individual views in a memorandum and place it in the administrative file related to the matter at hand. 2 The manager reviewing a matter should then discuss the issue with the parties involved and attempt to facilitate a resolution. If the parties still cannot reach a 2 FDA regulations stipulate that individual views and significant controversies or differences of opinion, and their resolution, should be documented in the official administrative file on a matter (21 CFR 10.70(b)). 3

resolution, then the manager should consider the recommendations and evidence shared and make a decision. Efforts should be made to resolve internal differences of opinion at the lowest organizational level possible. However, if a staff member is dissatisfied with the managerial decision, he or she may appeal for further review at a higher level. As the matter is considered by managers at successively higher levels of the supervisory chain, each manager involved should add to the administrative file a memorandum documenting how the difference of opinion has been addressed at his or her level. The administrative file should also include documentation of the final decision on the matter and the basis for this decision. All documents placed in the administrative file must be signed and dated by the individual identified as the author. 3 If a staff member has reason to believe (1) that resolution of a disagreement through a stepwise progression up the supervisory chain will jeopardize a pending statutory deadline, 4 or (2) that a specific regulatory action (or inaction) over which there is disagreement will have a significant and immediate negative impact on the public health, and that the disagreement will not be addressed in a sufficiently timely manner through a stepwise progression up the supervisory chain, it is CDRH s policy to ensure that the staff member have the opportunity for his or her views to be heard and considered by CDRH leadership through an expedited process. (See Section 6.6, below.) If a staff member involved in an internal disagreement has exhausted the CDRH process for resolving internal differences of opinion and is not satisfied with the resulting Center-level decision, he or she may appeal that decision at the Agency level. The Agency-level appeals process for scientific disputes is described in FDA Staff Manual Guide 9010.1. 5 4. DEFINITIONS 4.1. Administrative File. An administrative file is the official Agency record on a matter. As discussed in 21 CFR 10.70, a complete administrative file must be maintained for every significant FDA decision on any matter under the laws administered by the Commissioner. Specific regulatory requirements for administrative files are described in Section 5, below. 4.2. Appealing Party. An appealing party is any staff member (or group of staff members), including managers, who submits a request for a regulatory decision which a manager has made through the process described in this SOP to be reviewed by a higher-level manager. 4.3. Concurrence. A manager s concurrence, usually indicated by initials or a signature (written or electronic) on the official document such as a review, recommendation, or 3 Electronic signatures are acceptable. 4 Product approvals and clearances, while subject to Agency commitments, are not subject to statutory deadlines. 5 Only scientific disputes are eligible for the Agency-level appeals process described in Staff Manual Guide 9010.1. However, staff members may also seek to have non-scientific decisions reviewed at the Agency level as described in 21 CFR 10.75. 4

decision memorandum, means: (1) that the manager finds that the document is in the required format and meets all applicable guidelines; (2) that the manager believes the document is complete and has considered the critical scientific and regulatory issues; and (3) that the manager accepts all of the author s conclusions and recommendations. 4.4. Eligible Difference of Opinion. The process described in this SOP is intended to address internal differences of opinion that are consequential to regulatory decisions. Eligible differences of opinion may be scientific (involving the interpretation of scientific evidence to support a decision), non-scientific (involving the interpretation or application of law or policy), or a combination of the two. This process does not apply to: (1) personnel disputes, such as Equal Employment Opportunity (EEO), labor, or employment disputes, or issues related to the work environment; (2) issues related to the process by which a decision was made, such as questions about whether the appropriate staff members were invited to decision-making meetings; 6 (3) supervisory oversight of the quality of documents, such as edits related to formatting or clarity of language; or (4) clearance of speeches, presentations, or publications. 7 4.5. Initiator. The initiator of the process described in this SOP is the party who disagrees with a conclusion, recommendation, or decision made within CDRH in the process of regulatory decision-making. The initiator may be an individual, group, or organizational unit (e.g., Division or Office) involved in the decision-making process at any level. For example, the initiator may be a member of a review team, or a manager who is preparing to concur on a review document. Although the language of this SOP refers to a singular initiator, there may in some cases be more than one initiator. Documents written by a group of initiators should be signed by all individuals in the group. 4.6. Joint Memorandum. For the purposes of this SOP, a memorandum jointly placed in the administrative file may be co-written by the staff members indicated, or it may be drafted by a subset of the group and signed by the others to indicate agreement. All signees are responsible for assuring the accuracy of joint memoranda. 4.7. Manager. For the purposes of this SOP, the term manager will refer to any individual who has supervisory authority over another staff member. This term does not apply to line employees, such as lead reviewers, who have requested and received a consult on a particular scientific matter. The term immediate supervisor is used in this document to refer to the manager immediately above the initiator. The supervisory chain is the chain of managerial oversight beginning at the level of a given staff member and ending at the level of the Center Director. The terms next-level manager and higher-level manager are used in this document to refer to managers at progressively higher levels of the supervisory chain. 6 If a staff member takes issue with a particular aspect of the process by which a decision was made, that staff member should first discuss the issue with his or her immediate supervisor and attempt to reach a resolution. If the staff member and the supervisor are unable to reach a resolution, the staff member should refer the issue to the CDRH Ombudsman. 7 Staff members should follow the established procedures for clearance of such materials. These clearances are also subject to the Federal Food, Drug, and Cosmetic Act 21 USC 379d-2. 5

4.8. Relevant Resource. Individuals involved in the process described in this SOP may turn to relevant resources on a matter to gain a better understanding of the issue at hand and to aid in addressing it. The term relevant resource applies to other Center, Agency, or appropriate federal government staff with related expertise, Special Government Employee homework assignments, journal articles, or the individual s own professional knowledge and experience. In the case of scientific differences of opinion, relevant resources should rely on scientific evidence to support their conclusions and/or recommendations (see Section 4.10, below). 4.9. Resolution. For the purposes of this SOP, resolution of a difference of opinion refers to one of the following: (1) coming to a decision that all parties involved in the disagreement are willing to accept, or (2) coming to a decision that is not subject to appeal (i.e., at the highest level of the supervisory chain). 4.10. Scientific Evidence. FDA is committed to making regulatory decisions based on scientific evidence. Examples of what types of information can be used as scientific evidence for the purposes of this SOP can be found in 21 CFR 807.87(g), 8 807.92(b), 9 and 860.7(c)(2). 10 4.11. Special Government Employee Homework Assignment. In the course of reviewing a decision, a manager may seek advice from select Special Government Employees (SGEs) 8 21 CFR 807.87(g) states, Where a person required to register intends to introduce into commercial distribution a device that has undergone a significant change or modification that could significantly affect the safety or effectiveness of the device, or the device is to be marketed for a new or different indication for use, the premarket notification submission must include appropriate supporting data to show that the manufacturer has considered what consequences and effects the change or modification or new use might have on the safety and effectiveness of the device. 9 21 CFR 807.92(b) states, 510(k) summaries for those premarket submissions in which a determination of substantial equivalence is also based on an assessment of performance data shall contain the following information: (1) A brief discussion of the nonclinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence; (2) A brief discussion of the clinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence. This discussion shall include, where applicable, a description of the subjects upon whom the device was tested, a discussion of the safety or effectiveness data obtained from the testing, with specific reference to adverse effects and complications, and any other information from the clinical testing relevant to a determination of substantial equivalence; and (3) The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device identified in paragraph (a)(3) of this section. 10 21 CFR 860.7 states, Valid scientific evidence is evidence from well-controlled investigations, partially controlled studies, studies and objective trials without matched controls, well-documented case histories conducted by qualified experts, and reports of significant human experience with a marketed device, from which it can fairly and responsibly be concluded by qualified experts that there is reasonable assurance of the safety and effectiveness of a device under its conditions of use. The evidence required may vary according to the characteristics of the device, its conditions of use, the existence and adequacy of warnings and other restrictions, and the extent of experience with its use. Isolated case reports, random experience, reports lacking sufficient details to permit scientific evaluation, and unsubstantiated opinions are not regarded as valid scientific evidence to show safety or effectiveness. Such information may be considered, however, in identifying a device the safety and effectiveness of which is questionable. 6

with relevant expertise. Through an SGE homework assignment, an SGE will be asked independently to consider a particular issue and provide recommendations. Any such recommendations should be documented in writing and included in the administrative file on the matter. 5. REQUIREMENTS FOR ADMINISTRATIVE FILES FDA s Administrative Practices and Procedures Regulation, 21 CFR 10.70, establishes Agency requirements for administrative files. These requirements apply to every significant Agency decision on any matter under the laws administered by the Agency, regardless of whether there is an internal difference of opinion on the matter. This section highlights relevant provisions of the regulation. According to the regulation, FDA employees responsible for handling a matter are responsible for insuring the completeness of the administrative file relating to it. The administrative file on a particular matter is usually maintained in the Office working on the matter. When an internal difference of opinion is not associated with a specific product or a file that already exists in an Office, the CDRH Ombudsman will maintain an administrative file of documents related to the process for resolving internal differences of opinion. The administrative file must contain appropriate documentation of the basis for a decision, including relevant reviews, memoranda, checklists, flowcharts, opinions of consultants, letters, and minutes of meetings. The file must also contain the recommendations and decisions of individual staff members, including managers. The file must reveal significant controversies or differences of opinion, if they exist, as well as the basis for their resolution. The record of a differing opinion on a matter subject to disagreement must remain part of the administrative file even after a final decision on the matter has been made. All documents placed in an administrative file must relate to the factual, scientific, or regulatory issues under consideration. Each document placed in the administrative file must be dated and signed by the individual identified as the author, and shall be considered the author s own work. 11 In the course of completing the document, the author may develop successive drafts or alter the primary draft with the intent of clarifying points or improving the document. Early drafts are not considered part of the administrative file on a matter and can be discarded. The individual identified as the author of a document placed in the administrative file is personally responsible for assuring that it is accurate, appropriate in tone, and written clearly. When the document in question reflects a regulatory decision on behalf of CDRH, as does an action letter to an applicant, the designated signatory authority is responsible for all of the above, 11 If a document has multiple authors, all individuals indicated as authors must sign and date it. 7

and also for assuring that the document is consistent with Agency regulations and policy and represents the institutional position of the Agency. 12 If a document placed in the administrative file contains the views, analyses, recommendations, or decisions of an Agency employee or employees in addition to the author of that document, a copy of the document must be provided to those employees. The full distribution of all documents in the administrative file must be shown. Once a document is placed in the administrative file (i.e., in dated and signed form), it may not be altered, added to, or removed by anyone, including the author. Later additions, revisions, or corrections must be made by adding a new document to the file. Documents in an administrative file should avoid defamatory or intemperate language, undocumented charges, or irrelevant remarks (e.g., personnel complaints). The administrative file may be a paper or electronic file. As electronic policies and procedures change, CDRH will ensure that they conform with and support the requirements of this SOP. When CDRH moves to electronic tracking, the documentation required by this SOP should preferentially be documented and maintained in the appropriate Center electronic system. 13 6. PROCEDURES The following sections describe the procedures that Center staff members are to follow in the event of a difference of opinion at any level of the regulatory decision-making process. Any Center staff member may freely contact the CDRH Ombudsman to obtain general information about the process for resolving internal differences of opinion, or to discuss a particular internal difference of opinion and seek advice on the appropriate course of action. Communications with the Ombudsman are kept confidential, except in rare instances such as investigations or situations involving a risk of injury. 6.1. Development of Conclusions and Recommendations 6.1.1. Often CDRH employees are responsible for reviewing scientific or technical documents and making conclusions and/or recommendations. These recommendations may subsequently be reviewed by higher-level managers for final approval and regulatory action. 6.1.2. In the course of developing a document that provides conclusions or recommendations, such as a product review, a staff member may consult with his or her immediate supervisor, peers, or others within the Agency, particularly if the matter at hand presents complex issues. In turn, the immediate supervisor (or others) should advise freely with 12 In some cases, a manager may ask another staff member to draft a document on his or her behalf. If the manager is identified as the signee of the final document, he or she is responsible for its content. 13 For example, if an Office maintains an IMAGE file as the administrative file on a matter, the IMAGE file should include the documentation described in this SOP. 8

the intent of assisting the author in evaluating available data. Managers may provide feedback, comments, and edits on a draft in the spirit of raising points for discussion or improving the quality or clarity of the document. However, a manager may not order an author to make changes to a document. Responsibility for the content of any document placed in the administrative file on a matter rests with the individual identified as the author of that document. 6.2. Differences of Opinion Between Peers in a Single Office 6.2.1. If a difference of opinion arises between peers on a review team, the team should first attempt to resolve the disagreement through discussion. The lead author of the review document should take all team members perspectives into consideration when finalizing the review. The lead author should provide a copy of the review document to all team members once it is finalized. 6.2.2. If a team member feels that he or she cannot accept the conclusions or recommendations of a finalized review (i.e., a review by the team leader), then that team member may choose to become the initiator of the process for resolving internal differences of opinion. 6.2.3. To begin this process, the initiator should submit an initiation memorandum to his or her immediate supervisor, with a copy to the CDRH Ombudsman, clearly documenting: (1) the nature of any differences of opinion; (2) the basis for the initiator s position on each issue raised; (3) what additional information or evaluations, if any, would be needed to resolve each issue raised; and (4) the initiator s recommendation on each issue raised and the basis for each recommendation. Scientific assertions in the memorandum should be supported by scientific evidence. The initiation memorandum should also be added to the administrative file. 6.2.4. The CDRH Ombudsman should evaluate the memorandum to determine: (1) whether or not it is complete; and (2) whether or not the difference of opinion is eligible to be addressed through this SOP (see Section 4.4, above). The Ombudsman should notify the initiator and manager of whether or not the memorandum is complete and eligible no later than 10 calendar days after receipt. 6.2.5. The manager may, at his or her discretion, turn to relevant resources in order to develop a thorough understanding of the issue at hand and aid in addressing it. If additional information or recommendations not previously included in the administrative file are brought to bear, such information or recommendations should be added to the file and shared with the parties involved in the disagreement. 6.2.6. Before and/or after making use of the resources described in Section 6.2.5, above, the manager should meet with the parties involved in the disagreement, preferably together, and attempt to facilitate a resolution. 9

6.2.7. If the parties are able to resolve the difference of opinion through discussion, then they should jointly (and with the manager) place a memorandum in the administrative file, clearly documenting the discussion and the resolution reached. 14 6.2.8. If the parties are not able to resolve the difference of opinion through discussion, then the manager should consider the administrative file, including relevant documents and recommendations, and make a decision. The manager should then place a decision memorandum in the administrative file, clearly documenting: (1) the efforts made to resolve the difference of opinion at this level of the supervisory chain; and (2) the manager s decision(s) on the issue(s) raised and the basis for each decision. Scientific assertions in the memorandum should be supported by scientific evidence. The manager should send a copy of the decision memorandum to the involved parties, with a copy to the CDRH Ombudsman, no later than 30 calendar days after receipt of the complete and eligible initiation memorandum, unless the manager chooses to consult with other individuals not involved in the disagreement (such as SGEs or other Agency staff members). If the manager chooses to consult with other individuals not involved in the disagreement, he or she should issue the decision memorandum no later than 45 calendar days after receipt of the complete and eligible initiation memorandum. 6.2.9. If the initiator or any other involved party is not satisfied with the manager s decision, he or she may choose to appeal the decision. The appeals process is described in Section 6.5, below. 6.3. Differences of Opinion Between Peers in Two or More Offices 6.3.1. If a disagreement arises between staff members in two or more Offices and a staff member wishes to initiate the process described above, that staff member should send the initiation memorandum to the immediate supervisor of involved staff members in each Office involved, with a copy to the CDRH Ombudsman, following the guidelines described in Section 6.2.3, above. As described above, the initiation memorandum should also be added to the administrative file. 6.3.2. The CDRH Ombudsman should evaluate the initiation memorandum for completeness and eligibility as described in Section 6.2.4, above, and should notify the initiator and all immediate supervisors involved of whether or not the initiation memorandum is complete and eligible no later than 10 calendar days after receipt. 6.3.3. All managers involved may, at their discretion, turn to relevant resources in order to develop a thorough understanding of the issue at hand and aid in addressing it, as described in Section 6.2.5, above. 6.3.4. Before and/or after making use of the resources described in Section 6.2.5, above, all managers involved should jointly meet with the parties to the disagreement, preferably together, as described in Section 6.2.6, above. 14 Such a memorandum may be co-written by the staff members involved (including the manager), or it may be drafted by a subset of the group and signed by the others to indicate concurrence. 10

6.3.5. If the parties are able to resolve the difference of opinion through discussion, then they should jointly (and with all managers involved) place a memorandum to that effect in the administrative file, as described in Section 6.2.7, above. 6.3.6. If the parties are not able to resolve the difference of opinion through discussion, all managers involved should jointly make a decision and issue a decision memorandum, following the guidelines described in Section 6.2.8, above. 6.3.7. If the managers involved are unable to agree upon a joint decision, each manager involved should make his or her own decision and place an individual decision memorandum in the administrative file, following the guidelines described in Section 6.2.8, above. In addition to sending a copy of his or her decision memorandum to the CDRH Ombudsman and other involved parties, as described above, each manager should send a copy to the Director of each Office involved. 6.3.8. The Office Directors involved should then respond according to the procedures described in Sections 6.3.3 through 6.3.6, above. If the Office Directors are unable to agree upon a joint decision, each Office Director involved should make his or her own decision and place an individual decision memorandum in the administrative file, following the guidelines described in Section 6.2.8, above. In addition to sending a copy of his or her decision memorandum to the CDRH Ombudsman and other involved parties, as described above, each Office Director should send a copy to the Center Director. 6.3.9. The Center Director should then respond according to the procedures described in Sections 6.5.5 through 6.5.11, below. 6.3.10. If the initiator or any other involved party is not satisfied with a joint decision agreed upon by the managers involved, he or she may choose to appeal the decision. The appeals process is described in Section 6.5, below. Because managers in multiple Offices made the decision jointly, all Offices involved should be jointly engaged in the appeals process (just as all Offices involved were jointly engaged in the initial supervisory review). 6.4. Differences of Opinion Between Managers and Employees 6.4.1. When a manager reviews a final document authored by his or her employee, the manager typically indicates his or her concurrence by initialing or signing the completed document. 6.4.2. If a manager feels that he or she cannot give concurrence, in part or in whole, on an official document under his or her review because of a substantive difference of opinion, the manager should first discuss the situation with the author and attempt to resolve the situation. The manager may not order the author to change substantive content (including the conclusions or recommendations) of the document. 11

6.4.3. If the manager and author are able to resolve the difference of opinion through discussion, then they should jointly place a memorandum in the administrative file, clearly documenting the discussion and the resolution reached. 6.4.4. If the manager and author are not able to resolve the difference of opinion through discussion, then the manager should prepare an initiation memorandum, following the guidelines described in Section 6.2.3, above. As described above, the manager should submit the initiation memorandum to his or her immediate supervisor (i.e., the secondlevel manager), with a copy to the CDRH Ombudsman. The initiation memorandum should also be added to the administrative file. 6.4.5. The CDRH Ombudsman should evaluate the initiation memorandum for completeness and eligibility as described in Section 6.2.4, above, and should notify the initiator (i.e., the first-level manager) and the second-level manager of whether or not the initiation memorandum is complete and eligible no later than 10 calendar days after receipt. 6.4.6. The second-level manager may, at his or her discretion, turn to relevant resources in order to develop a thorough understanding of the issue at hand and aid in addressing it, as described in Section 6.2.5, above. 6.4.7. Before and/or after making use of the resources described in Section 6.2.5, above, the second-level manager should meet with the parties to the disagreement (i.e., the firstlevel manager and the author), preferably together, as described in Section 6.2.6, above. 6.4.8. If the parties are able to resolve the difference of opinion through discussion, then they should jointly (and with the second-level manager) place a memorandum to that effect in the administrative file, as described in Section 6.2.7, above. 6.4.9. If the parties are not able to resolve the difference of opinion through discussion, the second-level manager should make a decision and issue a decision memorandum, following the guidelines described in Section 6.2.8, above. 6.4.10. If the first-level manager or the author is not satisfied with the second-level manager s decision, either party may choose to appeal the decision. The appeals process is described in Section 6.5, below. 6.5. Appeals 6.5.1. If any CDRH staff member involved in an internal disagreement (e.g., an initiator, a manager, or any other involved party) is not satisfied with the managerial decision made through this process (i.e., in a decision memorandum), he or she may choose to appeal that decision to the next supervisory level. Appeals should be made no later than 10 calendar days after the staff member receives the manager s decision memorandum. 6.5.2. To begin the appeals process, the appealing party should submit an initiation memorandum to the next-level manager, with a copy to the CDRH Ombudsman and the 12

Center Director, following the guidelines described in Section 6.2.3, above. As described above, the initiation memorandum should also be added to the administrative file. 6.5.3. The CDRH Ombudsman and next-level manager should respond to the appealing party s initiation memorandum following the procedures described in Sections 6.2.4 through 6.2.8, above. 6.5.4. An appealing party may choose to appeal a decision at each level of the supervisory chain, all the way up to the level of the Center Director. The appealing party should submit a new initiation memorandum for each appeal. To make an appeal, the appealing party should submit his or her initiation memorandum no later than 10 calendar days after he or she receives the most recent decision memorandum. 6.5.5. When a difference of opinion reaches the level of the Center Director, the Center Director may turn to relevant resources in order to develop a thorough understanding of the issue at hand and aid in addressing it. If additional information or recommendations not previously included in the administrative file are brought to bear, such information or recommendations should be added to the file and shared with the parties involved in the disagreement. 6.5.6. In addition to using the relevant resources described in Section 4.8, the Center Director may also choose, at his or her discretion, to convene an ad hoc review committee to consider the disagreement and provide recommendations. If the Center Director decides to convene an ad hoc review committee, the committee members should be appointed no later than 15 calendar days after receipt of the complete appeal memorandum. 6.5.7. The ad hoc review committee should include a chairperson with relevant expertise, appointed by the Center Director. The chair may be an FDA employee or a Special Government Employee, chosen at the Center Director s discretion. The chair will, in consultation with the Center Director, appoint additional committee members with relevant expertise and experience, in a number of the Center Director s choosing. Only one member of the committee (including the chair) may be a Special Government Employee; the others should be FDA employees. To the extent possible, the ad hoc review committee should not include individuals who have already directly participated in the decision-making process on the issue at hand. 6.5.8. Once the members of the ad hoc review committee have been appointed, the CDRH Ombudsman should forward to them the appeal memorandum and related documentation. The committee should then work together to consider the disagreement and relevant materials; request technical assistance and additional documentation (e.g., reviews, meeting minutes) from appropriate sources within the Agency, as necessary; and issue a written report to the Center Director recommending the appropriate course of action to be taken. This recommendation will be non-binding. If the committee is unable to reach a consensus, the report should reflect the differing opinions of the committee members. The committee should take no more than 30 calendar days to collect and review the necessary information and to submit the report to the Center Director with a copy to the 13

CDRH Ombudsman. The CDRH Ombudsman should then place the committee report in the administrative file and share it with the parties involved in the disagreement. 6.5.9. Before and/or after making use of the resources described in Section 6.5.5 through 6.5.8, above, the Center Director should meet with the parties involved in the disagreement, preferably together, and attempt to facilitate a resolution. If the Center Director has convened an ad hoc review committee on the matter at hand, he or she should discuss the committee report with the parties to the disagreement. 6.5.10. If the parties are able to resolve the difference of opinion through discussion, then they should jointly (and with the Center Director) place a memorandum in the administrative file, clearly documenting the discussion and the resolution reached. 6.5.11. If the parties are not able to resolve the difference of opinion through discussion, then the Center Director should consider the administrative file, including relevant documents and recommendations and the ad hoc review committee report, and make a decision. The Center Director should then place a decision memorandum in the administrative file, clearly documenting: (1) the efforts made to resolve the difference of opinion at the level of the Center Director; and (2) the Center Director s decision on the issue(s) raised and the basis for each decision. Scientific assertions in the memorandum should be supported by scientific evidence. The Center Director should send a copy of the decision memorandum to the appealing party, with copies to other involved parties and the CDRH Ombudsman. The Center Director should issue the decision memorandum no later than 30 calendar days after receipt of the complete initiation memorandum, unless he or she chooses to consult with other individuals not involved in the disagreement (such as SGEs or other Agency staff members), or to convene an ad hoc review committee. If the Center Director chooses to consult with other individuals not involved in the disagreement, he or she should issue the decision memorandum no later than 45 calendar days after receipt of the complete initiation memorandum. If the Center Director chooses to convene an ad hoc review committee, he or she should issue the decision memorandum no later than 75 days after receipt of the complete initiation memorandum. 6.5.12. If the appealing party is not satisfied with the Center Director s decision, that party may seek to have the matter reviewed at the Agency level as described in 21 CFR 10.75. In the case of a scientific dispute, the appealing party should follow the process described in FDA Staff Manual Guide 9010.1. As specified in FDA Staff Manual Guide 9010.1, agency-level appeals regarding scientific disputes should be made no later than 10 calendar days after the appealing party receives the Center Director s decision memorandum. 6.5.13. If the appealing party chooses to withdraw the difference of opinion from consideration at any stage of the process (either because the parties involved in the disagreement have independently resolved their differences of opinion, or for any other reason), the appealing party should place a memorandum in the administrative file, documenting the withdrawal. A copy of the memorandum should be sent to the CDRH Ombudsman and to the official at the level where the difference of opinion is currently pending. 14

6.5.14. Once a difference of opinion has been resolved either (1) through acceptance of a decision by the parties involved or (2) through arrival at a decision that is not subject to appeal (i.e., a decision made at the highest supervisory level) all staff members should abide by the final decision. 6.6. Expedited Review of Internal Differences of Opinion 6.6.1. If the appealing party has reason to believe that resolution of a disagreement through the stepwise appeals process described above will jeopardize a pending statutory deadline, such as the deadline for a decision on an Investigational Device Exemption, he or she may appeal directly to the appropriate Office Director (skipping lower-level managers but not yet reaching the Center Director). In such a case, the appealing party s initiation memorandum should be sent to the Office Director, the CDRH Ombudsman, with and the Center Director, and should include a clear statement of justification for expedited action, in addition to the requirements specified in Section 6.5.2, above. Appeals directly to the Office Director should be vetted by the CDRH Ombudsman for completeness and eligibility, as described in Section 6.2.4, above. 6.6.2. Once the CDRH Ombudsman has received a complete initiation memorandum with a request for expedited review, he or she will then, in consultation with the involved Office Director, evaluate the request and determine whether or not expedited review is warranted. The CDRH Ombudsman should make this determination and notify the appealing party in writing, with a copy to the involved Office Director, no later than 10 calendar days after receipt of the complete initiation memorandum. This written response should also be added to the administrative file. 6.6.3. If it is determined that expedited review by the Office Director is not warranted, the CDRH Ombudsman will refer the matter to the appropriate lower-level manager. 6.6.4. If it is determined that expedited review by the Office Director is warranted, he or she should respond following the procedures described in Sections 6.2.5 through 6.2.8, above. 6.6.5. If the appealing party believes that a specific regulatory action (or inaction) over which there is disagreement will have a significant and immediate negative impact on the public health, and that the disagreement will not be addressed in a sufficiently timely manner through the stepwise appeals process described above, he or she may request that the CDRH Ombudsman raise the issue directly with the Center Director. In such a case, the appealing party s initiation memorandum should be sent only to the CDRH Ombudsman, and should include a clear statement of justification for expedited action on the basis of a risk to public health, in addition to the requirements specified in Section 6.5.2, above. Appeals directly to the Center Director should be vetted by the CDRH Ombudsman for completeness and eligibility, as described in Section 6.2.4, above. 15

6.6.6. Once the CDRH Ombudsman has received a complete initiation memorandum with a request for expedited review by the Center Director, he or she will, in consultation with the Center Director, evaluate the request and determine whether or not the expedited review by the Center Director is warranted. The Ombudsman should make this determination and notify the appealing party no later than 10 calendar days after receipt of the complete initiation memorandum. This written response should also be added to the administrative file. 6.6.7. If it is determined that expedited review by the Center Director is not warranted, the CDRH Ombudsman will refer the matter to the appropriate lower-level manager. 6.6.8. If it is determined that expedited review by the Center Director is warranted, the Center Director should respond following the procedures described in Sections 6.5.5 through 6.5.11, above. 6.6.9. The Center Director may choose, at his or her discretion, to elevate to his or her level a disagreement pending at a lower level of the supervisory chain. In such cases, the Center Director should place in the administrative file a memorandum clearly documenting the rationale for elevating the disagreement. The Center Director should then address the disagreement following the procedures described in Sections 6.5.5 through 6.5.11, above. 6.6.10. Decisions that result from expedited reviews of internal differences of opinion are subject to appeal, in accordance with the procedures described in Section 6.5, above. 6.7. Treatment of Related Regulatory Work during On-going Resolution of Internal Differences of Opinion 6.7.1. While the process for resolving internal differences of opinion is pending, related work up to but short of a final regulatory action (such as a product approval or clearance) except as specified in Section 6.7.2, below will continue unless the Center Director decides that: (a) The disagreement raises substantial questions involving a significant risk to the public health; and (b) Postponing the decision would not result in a negative impact on the public health. 15 6.7.2. Final regulatory actions that are subject to disagreement should generally be delayed until the differences of opinion have been resolved, except at the discretion of the Center Director. If the Center Director chooses to move forward with a regulatory action that is subject to disagreement, he or she should place in the administrative file a memorandum clearly documenting the rationale for doing so. 16 15 This exception is required by FDA Staff Manual Guide 9010.1. 16 This section does not apply to decisions on Investigational Device Exemptions, which should not be postponed. 16

6.7.3. At the discretion of the Center Director, the CDRH Ombudsman may notify the affected sponsor if a final regulatory action related to a product will be delayed because of a pending internal disagreement. 6.7.4. The mere act of initiating or being involved in the process described in this SOP, and thereby delaying a final regulatory action, will not adversely affect a staff member s performance rating. 7. RESPONSIBILITIES The following sections describe the responsibilities of Center staff members involved in an eligible internal disagreement. Involved parties may delegate their responsibilities in the event of a prolonged absence, unless otherwise directed by a higher-level manager. Note: See Section 6, above, for comprehensive procedures. 7.1. Authors are responsible for: 7.1.1. Consulting with their managers or peers within the Agency at any time during the process of developing recommendations, particularly if a case raises complex issues. 7.1.2. The content of any documents in the administrative file on which they are indicated as authors, including assuring that such documents are accurate, appropriate in tone, and written clearly. 7.1.3. Signing and dating documents on which they are indicated as authors before the documents are placed in the administrative file. 7.2. Initiators are responsible for: 7.2.1. Attempting to resolve a difference of opinion between oneself and other parties to the disagreement through discussion prior to filing an initiation memorandum. 7.2.2. When a difference of opinion cannot be resolved through discussion, initiating the process for resolving internal differences of opinion by placing in the administrative file and submitting to the CDRH Ombudsman and the immediate supervisor an initiation memorandum, clearly documenting (1) the nature of any differences of opinion; (2) the basis for the initiator s position on each issue raised; (3) what additional information or evaluations, if any, would be needed to resolve each issue raised; and (4) the initiator s recommendation on each issue raised and the basis for each recommendation. Providing scientific evidence to support any scientific assertions made in the memorandum. 7.2.3. If the disagreement is between staff members in more than one Office, sending the initiation memorandum to the immediate supervisor in each Office involved. 17