Shawn M. Schmitt
Latest From Shawn M. Schmitt
The US agency’s new guidance doc lays bare the types of submissions device and drug makers should send to the agency electronically.
The former FDAer who wrote the Quality System Regulation in the 1990s says the US agency should change the name of the rule, which has been undergoing a revision since 2018 to be harmonized with international quality systems standard ISO 13485. A name change would help delineate the retooled reg from its GMP predecessors, said Trautman, who also shared a few other thoughts about the agency’s ongoing QSR redo.
October 2020 is the new in-house target date for the US agency to release a draft of its revised QSR, which will be harmonized with international quality systems standard ISO 13485.
US FDA commissioner Stephen Hahn said on 10 July that the agency has a plan to send investigators back into the field in 10 days. Whether or not a company is inspected, however, will depend on local COVID-19 conditions.
US Regulatory Roundup, June 2020: FDA Talks QSR Redo; ISO Risk Standard Gets Companion Doc; Experts Predict Recalls Surge; And More
News out of the US FDA on the harmonization of its Quality System Regulation with ISO 13485, as well as stories on a new ISO technical report on risk management and a warning from experts about probable recalls because of the COVID-19 pandemic, were of most interest to our readers last month. Here are June’s 10 most popular US regulation and policy stories from Medtech Insight.
Luminex Corp., maker of the Verigene Processor SP System, was cited for quality systems and product recall violations. It’s one of three device-related enforcement missives released by the US FDA this week.