How FDA Is Evolving Its Regulatory Practices in the Age of COVID

Like all organizations facing disruptions from the COVID-19 pandemic, the FDA is adapting to the needs of its industry and employees. This week the Agency released a new guidance document for the device industry highlighting the measures they’re taking to keep submissions on track while prioritizing the safety of all involved. Here are some notable points from the Q&A-style document:

• As with most businesses, meetings are being held by phone and webinar.
• Though there are no current device advisory committee meetings on the calendar, a virtual format for meetings of this type is under consideration.
• While COVID-related regulatory activities are being prioritized, the Agency is still on target with its projected timelines.
• FDA remains committed to achieving the goals set under the user fee program, though they caution that they may not be able to maintain their current pace.

We applaud the FDA for remaining nimble in these challenging times and appreciate the CDRH’s invaluable contributions to mitigating the effects of COVID while continuing to serve the diverse and urgent unmet medical needs represented by the entirety of the device industry.