In a Federal Register notice titled Effects of the COVID‑19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices–Questions and Answers (Revised); Withdrawal of Guidance (Docket No. FDA-2020-D-1138), which appeared in the prepublication section (usually meaning it will become official the next day but, because of the weekend, the final publication date is scheduled for today, June 6, 2022), the Agency announced the withdrawal of the Q&A guidance document, saying that many of the issues outlined in it are no longer necessary based on the evolution of both COVID‑19 and the Agency’s current capabilities. The regulatory relief described in the original guidance will cease thirty days after final publication in the Federal Register notice.
Over the course of the pandemic, the Agency has made several decisions that were directed at reducing the regulatory burden on the device and drug industry. For instance, “FDA did not intend to consider a submission or application to be withdrawn for an additional 180 days beyond the relevant response date,” whether or not the sponsor has requested an extension. Now that process reverts back to that prior to the pandemic and is no longer acceptable unless a specific arrangement or agreement between the sponsor and the review division is in place. The document also discusses the FDA’s intent to hold only virtual advisory meetings and notes that, post-pandemic, the FDA will begin assessing the appropriate venue for advisory committee meetings.
The prepublication of the FR notice can be found here and the guidance document, which was issued in June 2020 and updated in December 2020, can be found here.
