SOP: Management of Review Staff Changes During the Review of a Premarket Submission
This document describes Standard Operating Procedures (SOP) for CDRH’s management of review staff changes during the review of a premarket submission.1
CDRH strives to provide timely and consistent feedback and guidance to submitters. On occasion, during the review of a premarket submission, staff turnover necessitates the reassignment of a premarket review team member.2 There are many valid reasons for reviewer reassignment including workload, details, extended leave, transfer, retirement, and resignation.
The procedures under this SOP are intended to minimize the impact of staff reassignment during premarket review to assure greater consistency in CDRH decision-making. Specifically, the objectives of this SOP are to:
- explain the roles and responsibilities of managers during staff reassignment;
- explain the roles and responsibilities of the newly assigned review staff; and,
- describe the process that newly assigned review team members should follow if they identify the need for a change in the amount or type of information previously requested by FDA of the submitter.
This SOP supersedes Blue Book Memo #I90-2 "Assignment of Review Documents," dated August 24, 1990.
As a general matter, a newly assigned review team member is expected to follow the decisions and advice given by the individual he or she is replacing. However, during his or her review of the submission, the newly assigned review team member may identify the need for a change in the amount or type of information previously requested by FDA of the submitter. Such a change may be needed because the submitter was asked to provide information that is not needed or was not asked to provide necessary information.
To promote consistency and to assure that any significant proposed changes are sufficiently justified, the newly assigned review team member must seek appropriate supervisory concurrence prior to contacting the submitter about the identified issue. In other words, when staff becomes aware of information that may alter the information and data required for premarket review, they should receive concurrence from the appropriate management level before taking any action.
For proposed changes in data requirements, staff should ask for data that imposes the least justified burden on the applicant.
4. Roles, Responsibilities and Procedures
Part 4.1 Roles and responsibilities of managers
4.1.1. The immediate supervisor of the departing review team member is responsible for identifying and assigning the new review team member. In most cases, the supervisor will be either a Branch Chief or a Division Director.
4.1.2. The immediate supervisor is responsible for the timely reassignment of staff once the staffing need is identified.
- When a submission is active (under review) or a consult is open, the supervisor should promptly reassign staff.
- When a submission is on hold, staff may not be immediately reassigned due to resource limitations. The Branch Chief or Division Director (or his or her designee) should serve as the Point-of-Contact (POC) until reassignment occurs.
4.1.3. When assigning a new review team member, the supervisor should consider the following:
- the professional and/or scientific expertise required for review of the device;
- the review team member’s experience and/or knowledge related to the submission, prior related submissions, subject matter, and/or device type;
- the relative workload of other reviewers and/or consultants;
4.1.4. The supervisor is responsible for documenting reassignments, which includes updating applicable tracking system(s) with the newly assigned review team member information. If the new assignment pertains to the lead reviewer, in addition to updating the tracking system(s), the supervisor should include, in the current active administrative file for the submission, a statement of the reasons for the new assignment. For example, an email from the reassigning supervisor explaining the reassignment is sufficient documentation.
4.1.5. The supervisor (or his or her designee) making the new assignment should inform members of the review team (as applicable).
4.1.6. When the departing staff member is a lead reviewer who has already had contact with the submitter and the submission is under active review, then the supervisor (or his or her designee) should inform the submitter of the new staff assignment.
Part 4.2. Roles and responsibilities of reassigned team members
4.2.1. After assignment, the newly assigned team member shall promptly familiarize him/herself with the submission, the administrative record, and if applicable, related submissions (e.g., relevant IDE).
4.2.2. After becoming familiar with the assignment, the newly assigned review team member is encouraged to seek clarification or additional information, as necessary, from his or her supervisor or other review team members familiar with the submission.
Part 4.3. Process for requesting and documenting a change in the amount or type of information
4.3.1. During his or her review of the submission, the newly assigned review team member may identify the need for a change in the amount or type of information previously requested by FDA of the submitter. Such a change may be needed because the submitter was asked to provide information that is not needed or was not asked to provide necessary information.
In such cases, the newly assigned review team member must seek supervisory concurrence prior to contacting the submitter about the identified issue.
4.3.2. The "SOP: Decision Authority for Additional or Changed Data Needs for Premarket Submissions procedures," should be used to determine the appropriate level of supervisory concurrence required. This SOP cannot address every circumstance that may occur in the review process. It should be used as a general guide when there is any doubt as to what level of concurrence may be necessary for additional or changed data requests.
4.3.3. If the newly assigned review team member has a different supervisor than the lead reviewer, then concurrence of the lead reviewer’s supervisor is also required.
4.3.4. All of the documentation for the interactions at the Branch, Division, and Office levels should be placed in the Administrative File for a complete Administrative Record.
1 For the purposes of this SOP, "premarket submission" refers to PMAs, PMA supplements and amendments, IDEs, IDE supplements and amendments, HDEs, and 510(k)s.
2 The pre-market review team includes but is not limited to a lead reviewer, other review team members, and consultants.