New FDA Reporting Requirements for Device Manufacturers During the Pandemic
The FDA has published new guidance requiring medical device makers to notify the agency of any significant interruptions in the supply chain of certain medical products to prevent or mitigate shortages during the COVID-19 pandemic. Manufacturers of products considered critical to the pandemic health response are required to report supply shortages to the FDA. The rule will only be in effect while the pandemic is considered a public health emergency in the U.S., according to the FDA.
Final Guidance: https://www.fda.gov/media/137712/download
HMMC members can provide comments on this guidance here: https://www.regulations.gov/docket?D=FDA-2020-D-1138