Regulatory Open Forum

ALL MEDICAL DEVICE COMPANIES GRANTED Covid-19 EUAs and THOSE GOVERNED BY Covid-19 PHS ENFORCEMENT POLICY:

Just out yesterday--US FDA new Draft Guidance on Transition Plans for Medical Device companies granted EUAs during Covid-19 Public Health Emergency.

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/transition-plan-medical-devices-fall-within-enforcement-policies-issued-during-coronavirus-disease 

There's a companion SEPARATE PDF Guidance for the PHS Enforcement Policy (* presumably not granted EUAs*)

Keen to hear feedback from all specifically with the CFR(s) compliance after EUA is terminated given the designated Phases and timing  referenced in the PDF Guidance, i.e. lots of moving parts here to understand and consider!

"353 If a manufacturer submits a marketing submission, and that submission is accepted before the
 354 beginning of Phase 3, FDA does not intend to object to the continued distribution of the devices
 355 within the scope of this guidance as described in Section V.E below. FDA expects manufacturers
 356 of such devices to comply with all other statutory and regulatory requirements applicable to their
 357 devices. These requirements include but are not limited to the Quality System (QS) regulation
 358 under 21 CFR Part 820 and Unique Device Identification under 21 CFR Part 801 Subpart B and
 359 21 CFR Part 830, if applicable."

Lots of gray areas given FDA's allowance for 'variance exemption' contained herein further into the Guidance.
Enjoy!