Lawmakers request details from FDA on third-party medical device reviews

Congressman Dan Crenshaw and Congresswoman Angie Craig have sent a letter to the Food and Drug Administration (FDA) seeking details on the agency’s plan for its medical device third-party review program. This program allows qualified private-sector reviewers to assess low-risk medical devices, aiming to expedite their review process at the FDA.

"We share your interest in advancing access to medical innovation and write regarding your recent comments on the 510(k) Third-Party Review program," Crenshaw and Craig wrote. "We agree that the principles of the Third-Party Review Program have great promise for increasing efficiency in device regulation. In particular, we see the promise of this program to streamline the review of well-understood device types, which can, in turn, maximize the FDA’s capability to address higher-risk devices … With this in mind, we suggest that the agency consider potential solutions and answer the following questions regarding its intentions expressed in the LDT Final Rule."

The full letter is available for reading online.

As a member of the House Energy and Commerce Subcommittee on Health, Rep. Crenshaw has been active in improving access to medical innovation. His efforts include sponsoring legislation aimed at expanding access to breakthrough therapies, enhancing the FDA’s review process for personalized medicine, and addressing chronic diseases such as traumatic brain injury and cancer.