CDRH Issues SOP to Define the Appropriate Management Decision Level for Making Changes to Data Requirements for Premarket Submissions

By Carmelina G. Allis –

A persistent industry complaint is that CDRH too often changes data requirements in the middle of a review, or requires data for a new device that was not required for predicate devices.

It appears that CDRH has taken a step toward addressing this complaint.  A new SOP issued by FDA’s Center for Devices and Radiological Health (“CDRH”) tries to define the responsibilities of management when CDRH review staff has identified the need to make changes in data requirements from what was requested in other premarket submissions or previous communications with a manufacturer.  “[W]hen staff become[] aware of new information that may alter the information and data required for premarket review [for a generic category of devices], they should receive concurrence from the appropriate management level before taking any action.”

Concurrence from the branch chief should be obtained for data requests that apply to a single device based on specific issues applicable to that particular device, or that are deemed necessary to support a new indication or new technology that is different from the predicate.  If the data request is for clinical studies, then the branch chief should take the matter to the division level for concurrence.  In addition, division level sign-off should be obtained for situations where animal testing is imposed as a new requirement, or non-clinical data are required because of new information obtained by the agency about the device type (e.g., device failures).  Division sign-off should also be required for “minor” changes to a clinical study, such as minor adjustments to an endpoint, and for changes that impact devices in other branches within the same Division.

Concurrence from the CDRH Office of Device Evaluation would be required for situations where the changes to data requirements would affect multiple branches and/or divisions, where the request would diverge from statements in a guidance document or pre-submission with the sponsor, or the request would impose major changes to an ongoing clinical study (e.g., requiring a new clinical study, changes from a single arm to a randomized study, etc.).  Concurrence from CDRH’s Center Science Council would be required for circumstances where the data requirements are to change significantly from what was previously requested, such as asking for clinical data when such studies had not been requested in the past.

The SOP clearly emphasizes the importance of obtaining written concurrence (e.g., via email) from the appropriate management level prior to implementing the change in data requests.

It is apparent from this SOP that manufacturers will not be included in the decision process – that is, the decision to change data requirements will be implemented if the appropriate manager concurs with the change, but nowhere does the SOP require that the decision-making process weigh in the manufacturer’s opinion on the matter.  Prior public notice, such as in the form of guidance or rulemaking, will be pursued as deemed necessary, such as for changes in data requirements applied across a class of products.

Obviously, the impact of this new SOP remains to be seen, but it is a step in the right direction.