📰 Device Reporting News
Page 2 - Device Reporting News Today
Fast, Ad-Free News Updates
Stay updated with breaking news from Device Reporting. Real-time updates on events, politics, business and more.
June 7, 2022
Falls Church, VA (PRWEB) June 07, 2022 -- Medical Device ReportingBest Practices and Common PitfallsAn FDAnews WebinarTuesday, June 21, 2022, 1:30
March 23, 2022
The FDA has officially announced its intention to harmonize and modernize 21 CFR Part 820 Quality Management System Regulation (QMSR) for medical...
March 1, 2022
The FDA is proposing to amend the current good manufacturing practice (cGMP) requirements of 21 CFR Part 820: Quality System Regulation (QSR) to...
February 24, 2022
The FDA is proposing to amend the current good manufacturing practice (cGMP) requirements of 21 CFR Part 820: Quality System Regulation (QSR) to...
December 16, 2021
Despite a substantial reduction in the number of inspections that the FDA conducted in FY 2021, the 483s that the agency issued are still very...
October 21, 2021
This article examines another major regulatory regime relevant to mHealth application developers – the Federal Food, Drug and Cosmetic Act (FDCA), as well as regulatory issues unique to...
October 20, 2021
This article examines another major regulatory regime relevant to mHealth application developers – the Federal Food, Drug and Cosmetic Act FDCA, as well as regulatory issues unique to non-US companies.
March 17, 2021
Trends In FDA Quality System Inspections: 3 Takeaways To Ensure Future Success By Adam Atherton, KEB, LLC The FDA conducts thousands of quality system inspections each year. The FDA performs inspections of medical device quality systems for products planned for or already on the U.S. commercial marketplace and publishes summaries of the inspection observations here. In this article, I present background and high-level observations on the inspection data over time. My next article will analyze F...