Icy HHS/FDA Relations Could Complicate An Already Drawn-Out Quality System Reg Rewrite

US Regulatory Roundup, September 2020

03 Oct 2020

• By Shawn M. Schmitt

A roundup of last month’s top US policy and regulation stories from Medtech Insight: the latest on the US FDA’s Quality System Regulation harmonization efforts; the FDA’s Bakul Patel talks the inevitable future of digital health; a Sanofi usability expert gives a peek at how the company’s conducting human factors studies in the age of COVID-19; and more.

News that the US Food and Drug Administration will likely miss its fourth internal target date for releasing a draft of its revised Quality System Regulation was of most interest to Medtech Insight readers last month. The agency’s device center director, Jeff Shuren, said in mid-September that manufacturers should “anticipate that it will be a little while longer before we’re able to issue the ISO 13485 [draft] regulation.”

The FDA has been harmonizing its QSR – 21 CFR, Part 820 – with international quality systems standard ISO 13485:2016...