Last week, FDA announced the availability of a draft standard operating procedure (Draft SOP) on CDRH’s process to quickly notify stakeholders when new scientific information changes CDRH’s expectations for the data required for premarket submissions, such as Investigational Device Exemption (IDE), Premarket Notification (510(k)), Premarket Approval (PMA), or Humanitarian Device Exemption (HDE) submissions.  The Draft SOP is available here.  Interested parties should submit comments by October 21, 2013.

As described in the Draft SOP, manufacturers typically learn after they have prepared and filed a premarket submission that CDRH has changed the requirements regarding the data necessary to support an IDE, 510(k), PMA, or HDE.  CDRH imposes the changed requirements immediately in this premarket review context when considered “necessary to protect the public health.”

Notification to the industry about changed expectations might then be communicated in guidance documents, but publication of guidance has often been delayed a year or more due to resource constraints and review procedures.  Recognizing this, the Draft SOP states that CDRH plans to invoke a provision of the Good Guidance Practices (GGP) regulations,  21 C.F.R. 10.115(g)(2), to support immediately in effect (IIE) guidance to quickly communicate and implement changes in premarket regulatory expectations.  This process does not require prior public comment.  CDRH may also occasionally use contemporaneous letters to industry to communicate these changes to stakeholders.

According to the Draft SOP, Premarket IIE Guidance should be considered when “new scientific information has been identified that raises a new, important safety risk or calls into question the adequacy of currently used test methods or clinical trial designs.”  Based on such information, if CDRH staff believe that regulatory expectations should be changed (e.g., there should be a change in the data manufacturers are expected to submit), and prior public participation is not appropriate or feasible, Premarket IIE Guidance may be initiated.  The CDRH staff should consult with the Center Science Council (CSC), and the CSC should determine: (1) whether the new information warrants a change in CDRH’s premarket regulatory expectations; (2) what procedures should be used to communicate CDRH’s new regulatory expectations (e.g., IIE guidance or standard guidance); and (3) whether additional expertise on the topic is needed to determine the appropriate response to the new information.

Depending on the CSC’s decision, a one-to-three-page Premarket IIE Guidance should be drafted.  The Premarket IIE Guidance should identify, among other things, the appropriate audience, the new scientific information and why it warrants the change, an explanation as to why prior public comment is not feasible or appropriate, and a discussion of the changes in regulatory expectations, such as additional data requirements.  It should also address whether the changed expectations will apply only to new submissions, or also to submissions already under review by CDRH.  If applied to pending submissions, CDRH should explain how the submitter can respond to the changes “so that they are not unfairly disadvantaged by the change.”

The Draft SOP also describes a process for the review, clearance, and issuance of Premarket IIE Guidances.  Even though the guidance would be immediately implemented, CDRH must publish a notice of availability in the Federal Register, request comments, and post a copy of the guidance to CDRH’s website.  CDRH must collect and review comments from the docket for 60 days after the publication of the Premarket IIE Guidance and determine whether the comments should be incorporated into the guidance.  A revised guidance should be issued 90 days after the initial comment period closes.

FDA has invited public comment on the Draft SOP for Premarket IIE Guidances, and the SOP will not be implemented until CDRH has considered comments.  Among other issues raised by this Draft SOP, one concern is the type of “new scientific information” that will be invoked to impose new data requirements or to reject test methods and clinical trial designs that had been long accepted or approved under IDEs.  Another concern relates to the likely impact of public comment after a guidance has already been made effective and implemented.