Barbara Binzak Blumenfeld, shareholder in the firm's FDA & Biotechnology practice, comments on the FDA's announcement of potential updates to its 501(k) clearance pathway for medical devices, which would lead to more modern predicate devices.
Barbara A. Binzak Blumenfeld, a shareholder at Buchanan, Ingersoll & Rooney who advises clients on FDA regulatory issues, said that the update wasn’t a surprise given the changing face of medical devices and the agency’s other recent initiatives. However, she recommended that device sponsors continue monitoring any updates from the agency on new guidelines and rules, as well as take advantage of the FDA’s various engagement programs to guide its policies in a way that benefits industry and the public.
“Focusing on modernizing the 510(k) program is a positive development, but the devil is always in the details,” Blumenfeld wrote to MobiHealthNews in an email. “For example, FDA is considering listing predicate devices that are more than 10 years old on its website. While this may be useful for future device innovation efforts, a device that is more than 10 years old can still be legally marketed and is not unsafe. So if any such ‘list’ on FDA’s website has a negative effect on use of those devices by medical practitioners and patients, then device sponsors may not view such a list favorably.”
Read the full article in MobiHealth News' article "FDA Looks to Restrict Older Predicate Devices, Introduce New Regulatory Pathway."