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 for more than two years. Back in July the...