CDRH Returning to Pre-Pandemic Timelines for Premarket Submission Holds

On June 3, FDA announced, via email to industry, that it plans to withdraw the guidance “Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices–Questions and Answers (Revised).”  This guidance did two things: (1) automatically extended hold times for additional information requests (e.g., PMA major deficiency letters, 510(k) additional information requests) by 180 days; and (2) communicated that all advisory committee meetings would be held virtually.  This notice will be published in the Federal Register (here).  The guidance will formally be withdrawn 30 days after the notice is published in the federal register (the “Withdrawal Date”).

So, what does this mean for submissions that have already received a hold letter and were counting on the additional 180 days to respond?  Not to worry.  Submissions that received a hold letter on or before the Withdrawal Date will still have the automatic extension.  Submissions that receive a hold letter after the Withdrawal Date will not receive the extended response time – in other words, they will have to respond in the standard time (e.g., 360 days for a PMA major deficiency letter and 180 days for a 510(k) or de novo additional information request).

FDA’s notice acknowledges that the circumstances leading to this policy have not been completely resolved.  For example, many in industry are experiencing painfully long wait times at labs performing tests like biocompatibility.  Questions regarding biocompatibility and other tests that are typically performed by third-party laboratories or that require production units that may be constrained by on-going supply chain issues, are not uncommon in hold letters.  We are hopeful that FDA will consider extra flexibility even after the policy formally ends given that many sponsors may struggle to meet the standard deadlines in light of on-going industry conditions.

Finally, the notice states that FDA will “assess the appropriate venue for advisory committee meetings, keeping in mind FDA’s successful implementation of virtual advisory committee meetings.”  FDA will continue to announce the location of advisory committee meetings via the Federal Register.  There is no indication from this notice or other FDA communications as to when in-person advisory committee meetings or other industry meetings will resume.