On September 6, 2018, FDA launched the Quality in 510(k) Review Program Pilot (“Quik”). With the name “Quik,” it has a lot to live up to. The goal of the program is to simplify the 510(k) process by providing an alternate method of preparing a …
On April 27, 2018 FDA released a draft guidance describing the regulatory approach and policy for multiple function device products. The draft guidance, Multiple Function Device Products: Policy and Considerations, is available here and has been issued in response to the 21st Century Cures Act section …
On November 16, 2017, FDA released four guidance documents that, together, the Agency described as a “comprehensive policy framework” for applying existing laws and regulations governing regenerative medicine products, including human cells, tissues, and cellular and tissue-based products (“HCT/Ps”). The policy framework is set forth …
Sponsors commonly receive a request for additional information (AI) during Food and Drug Administration (FDA) review of a 510(k) submission, de novo classification request, or premarket approval application. In some cases, a sponsor may conclude that one or more AI requests calls for information that …
