US FDA withdraws COVID-era guidance for medical device and IVD market approval processes

The US Food and Drug Administration announced that it has withdrawn its temporary policies related to the COVID-19 pandemic because they are no longer necessary. The agency released this news after twice previously announcing its transition plans to return to full agency operations. The withdrawal date is July 7, 2022, for all COVID-era enforcement policies.

The FDA has “continually assessed the needs and circumstances related to these temporary policies, and as relevant needs and circumstances evolved, the agency made updates and modifications.” Now the agency has announced a full withdrawal of COVID-era guidance and has issued a Q&A for medical device and in vitro diagnostic (IVD) device manufacturers to answer questions on which processes are affected.

Medical device and IVD manufacturers must prepare for full FDA registration

If you are a medical device or IVD manufacturer or supplier, you should prepare for a full return to pre-pandemic policies for marketing submissions and applications. This means the FDA will begin requiring manufacturers to meet all standard regulations applicable to your devices. If you have not applied for full FDA registration, you will be required to remove your devices from the US market.

How will medical device application processes be affected by the return to full FDA registration?

The FDA is reverting to pre-pandemic policies in the interest of patients receiving timely access to new medical and IVD devices. The following policies will return to the FDA’s regular regulatory process.

Full FDA compliance includes reverting to regular FDA policies regarding hold times. Hold times for submissions won’t be delayed any longer in order to “facilitate more timely review of innovative, potentially life-saving devices.” This means you must respond to major deficiency letters for Premarket Approval Applications (PMAs) or Humanitarian Device Exemptions (HDEs) within 360 days. You must respond to additional information letters for 510(k) and De Novo requests within 180 days.

As mentioned above, the withdrawal date for the guidance document is July 7, 2022. If you receive a major deficiency letter for a PMA or HDE application or an additional information letter for 510(k) or De Novo requests prior to or on the withdrawal date of July 7, you have an additional 180 days to respond beyond the letter’s relevant response date before the FDA will consider your submission withdrawn. If you receive any of these letters after the July 7 guidance withdrawal date, you must respond by the relevant response date indicated in the letter. If you don’t respond by the response date, the FDA will consider your submission withdrawn.

Emergo by UL will post updates to US FDA’s medical device regulatory guidance as they become available.

Learn more about complying with US FDA medical device regulations from Emergo by UL:

• UL ComplianceWire® LMS support for life sciences companies and manufacturers
• UL ComplianceWire® Emergency Use Qualification for vaccine producers and developers
• US FDA consulting for medical device and IVD manufacturer’s services

Original Article: (https://www.emergobyul.com/blog/2022/06/us-fda-withdraws-covid-era-guidance-medical-device-and-ivd-market-approval-processes)