Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Inside Health Policy, in “Device Makers Want FDA to Preview Post-Pandemic Flexibility Plans,” by Kelly Lienhard. (Read the full version – subscription required.)
Following is an excerpt:
Medical device manufacturers are urging FDA to release guidance detailing the agency’s expectations for products released under emergency use authorizations (EUAs) and emergency discretion guidances once the COVID-19 public health emergency comes to a close and the temporary approvals are suspended. The number of devices currently on the market under temporary authorizations is unprecedented and the industry is unable to craft future business plans without clear expectations from the agency, sources say. …
A representative from FDA declined to verify any upcoming guidances, but referenced a previous agency guidance that states once a public health emergency is terminated, FDA will consult with manufacturers concerning continued use of unapproved medical products that were distributed under EUAs. Patients already using the product will be allowed to continue, providing their health care provider approves, FDA suggested.
While the agency guidance states FDA will hold conversations with manufacturers after the pandemic, Brad Thompson, a member of the law firm Epstein Becker & Green and general counsel of the Combination Products Coalition, told Inside Health Policy that the agency will not be sympathetic to companies that have not been planning for regulation once the public health emergency ends and are using the lax regulation to their advantage to sell products.
“If you want to remain on the market after the emergency ends, you will not be able to rely on the fact that your product is important or that customers like it,” Thompson said. “You will need to show FDA that you spent the time of the emergency coming into compliance, doing the studies necessary for FDA clearance and pursuing the clearance.”
Thompson said many companies are concerned even though this is not the first time the medical device industry has undergone a public health crisis and seen emergency guidance from the agency, the scope of the COVID-19 pandemic is unprecedented and has seen the release of over 50 guidance documents that could be reversed.