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...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

Start your 7-day free trial
Explore trusted news, analysis, and insights
Access comprehensive global coverage
Enjoy instant access – no credit card required

Start Free Trial

Already a subscriber?

‘Dawn Of FDA’s AI Era’ Has Arrived. Makary Announces Early Implentation Of ‘Elsa’ Platform

04 Jun 2025

• By Brian Bossetta

US FDA Commissioner Marty Makary says the agency’s generative AI tool ‘Elsa’ will allow employees across the FDA to work more efficiently. The commissioner says Elsa’s launch comes ahead of schedule following a successful pilot program.

DeepLook AI Imaging Provides A Deeper Look At Dense Breast

03 Jun 2025

• By Brian Bossetta

DeepLook Medical recently announced the commercial rollout of DL Precise, an AI-powered imaging platform that enhances breast cancer screening, at major healthcare institutions across the US.

First AI Breast Cancer Prediction Platform Receives FDA Authorization

03 Jun 2025

• By Natasha Barrow

Clairity’s "first-in-class" mammography-based AI screening tool, Clairity Breast, provides "equitable risk assessments," expanding access to lifesaving early detection for breast cancer, said company founder Connie Lehman.