Effective Date: November 9, 2011
The purpose of this document is to define the appropriate decision level for making additions or changes in data requirements from what was requested for premarket submissions in previous communications. This SOP will provide criteria under which changes to recommendations for premarket data can stay at the Branch level, or should receive division level concurrence, or be escalated to the Office level for concurrence, or taken to the CDRH Center Science Council (CSC) for review and recommendation prior to implementation.
CDRH/ODE has delegated to the review divisions the authority to request additional data for some premarket submissions. Each review division has developed its own process and practice for these additional data requests, which has resulted in some inconsistencies in the process across divisions. In order to ensure consistency between the review branches and divisions, clarity on the appropriate decision level for additional data requests is provided in this document.
Reviewers may become aware of new information that would be applicable to the generic category of devices and may result in the need for additional premarket bench or clinical testing. This new information may be derived from literature articles, recalls, MDR or adverse event reports, data or studies in a submission currently under review, other safety or effectiveness information, or increased knowledge about a particular device type. In such cases, the new data requirements should be discussed with the appropriate Division, Office, or Center management level as discussed below. In other words, when staff becomes aware of new 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. Guidance or rulemaking may also be necessary for changes in data requirements applied across a class of products. The need for prior public notice should be discussed with management before implementing such changes.
For proposed changes in data requirements, staff should ask for data that imposes the least justified burden on the applicant. Under certain circumstances Office and CSC input regarding appropriate data requirements could be helpful and should be considered.
4. Responsibilities and Procedures
When a reviewer or manager becomes aware of a situation that may qualify under the criteria outlined in section 3, he/she should discuss with the next-level management as discussed below. All of the documentation for the interactions at the Branch, Division, Office, and CSC levels should be placed in the Administrative File for a complete Administrative Record. 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.
4.1 Branch Level Concurrence
The Branch Chief has the primary responsibility for identifying whether additional/ changed data requests should to be referred to higher level management before communicating with the sponsor through formal or informal mechanisms. Examples of when it may be appropriate for the sign-off authority to reside at the branch chief level are included below:
- A request for data will apply to a single device based on specific issues or data. Discuss at the division level if the data need is clinical.
- Data to support a new indication that is different from predicate devices. Discuss at the division level if the data need is clinical.
- New technology that is different from the predicate, but does not raise different types of safety and effectiveness questions.
4.2 Division Level Concurrence
The Branch Chief should request Division-level concurrence when additional information requests other than those addressed in 4.1 are contemplated. The Branch Chief may brief the Division Director or provide information electronically. The Branch Chief should obtain email concurrence from the Division on the information request, and this email should be included in the administrative record. If the Division Director is briefed, an email may be sent to all attendees to capture the important aspects of the conversation and then be added to the administrative record. Examples of when it may be appropriate for the sign-off authority to reside at the Division level are included below.
- Animal testing will now be required for a particular device type for which it previously had not been consistently required.
- Additional non-clinical data will be required for a device type due to clinical failures. That this is a new data request should be clearly explained to the sponsor and the basis for the request should be explained, unless the basis will reveal confidential information. In those cases the basis should be described in a general manner.
- Minor Changes to the Clinical Study such as:
- minor adjustment of the endpoint such as requesting additional clinical laboratory blood testing;
- the proposed change in data requirements is a minor and/or incremental change (e.g., a change in the interval for a follow-up visit with the clinical investigator to collect an additional data set for the test subject);
- other endpoint changes (e.g., 6 months to 1 year).
- Changes that impact devices in other branches in the division, but not beyond the division.
4.3 Office Level Concurrence
The Division Director (and/or Deputy Director) is responsible for identifying whether additional/changed data requests should to be referred to higher level management before communicating with the sponsor.
The Division should request Office-level concurrence when additional information requests will be made. Generally, the Division should schedule a briefing with the Office Director and/or Deputy Director. The Division should obtain email concurrence from the Office on the information request, and this email should be included in the administrative record. Examples of when it may be appropriate for the sign-off authority to reside at the Office level are included below.
- Changes made to data requirements for devices that are horizontal in nature and affect multiple Branches and/or Divisions.
- Request for additional data diverges from a final guidance document or from advice provided in a pre-submission interaction with the sponsor. In cases where the advice differs from guidance, the guidance document should be prioritized for revision as well.
- Major Deficiencies or Not Approvable decisions for PMA originals and panel-track supplements if the information needed to make the submission approvable involves new or different data from what had been agreed to in an IDE, Pre-IDE or an agreement meeting.
- Changes to an ongoing clinical study design, such as changes:
- during an ongoing IDE study that would invalidate the currently collected data or require an entirely new clinical study;
- from a single arm to a randomized study in the middle of an ongoing study;
- from a non-inferiority study to a superiority study in the middle of an ongoing study; and
- in the endpoint, such as adding a primary outcome endpoint in addition to the current secondary endpoint.
4.4 Presentation to the Center Science Council
The Office management is responsible for identifying whether additional/changed data requests should to be referred to the CSC. The Office may request review by the CSC when additional information requests such as those shown below will be made, or when broader input is sought on issues that have been referred to the Office for concurrence. The Branch Chief should draft a brief background memo explaining the issue and why it should be brought to the attention of the CSC. The CSC should be notified and a CSC briefing will be scheduled. Concurrence of the background material should be obtained from the Division and Office. The CSC has developed a detailed policy regarding their procedures including a flow chart and a template for the background material. Examples of when it may be appropriate to refer changed data requests to the CSC are included below.
- Clinical data requirements will apply broadly to a class of devices for which clinical data had not been requested in the past.
- Clinical data requirements that have already been applied to a class of devices need to change significantly