The FDA’s 510(k) process for medical devices is doing a lot of rounds in the news lately. This includes the FDA Commissioner Dr. Scott Gottlieb’s announcement on the renovation to the 510(k) program1 and two new pilot programs initiated by FDA: the Quality in 510(k)...
Every year FDA releases an annual report for Quality system inspections and enforcement action data for the Medical Device industry. For our blog this week, we are presenting a brief analysis of the data published by the FDA for the fiscal years 2015, 2016 and...
The revision of the Quality System Regulation [QSR] (21CFR 820) which was a priority set in FDA’s Spring unified agenda also made it to the FDA’s Fall unified agenda published in October 2018.1 The revision will replace the existing regulation in an effort to stay modernized...
The digital health software pre-certification program is FDA’s strong footstep in leading the way to support the inclusion of the digital world in the US healthcare industry. As part of FDA’s digital health innovation action plan, the pre-cert program was announced in July 2017, and...