Cost for QD employees to rent an apartment in Chico, CA. $1,200/month. Please turn off your ad blocker in Quality Digest
Our landlords thank you.
Michael Causey
Published: Tuesday, September 1, 2015 - 16:37 FDA will be taking applications starting Sept 1, 2015, looking for makers of class I and suitable class II medical devices to participate in a pilot program to file malfunction reports in summary form quarterly. Get on the stick, though, if you are interested: there are only nine slots. Under FDA’s Medical Device Reporting on Malfunctions, the agency hopes to streamline some reporting procedures. It wants any reports to include a “narrative text” with sufficient detail for a reviewer to understand what happened. The agency also expects to hear about subsequent investigations and corrective actions as necessary to address the situation(s). There’s a carrot, too: manufacturers accepted into the pilot will be granted an exemption or variance from, or alternative to, the usual reporting requirements under 803.5 and 803.52 for covered devices. Accepted candidates can withdraw from the pilot program at any time. FDA can drop participants, too. Pilot participants will be expected to submit FDA 3500A forms that cover a summary of malfunction events tied to a unique device problem code or set of codes within the quarterly timeframe, and for a particular device model number and/or catalog numbers. The program was announced via an August 18 notice in the Federal Register. For more information, contact William C. Malone, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 3236, Silver Spring, MD 20993-0002, 227pilot@fda.hhs.gov. Quality Digest does not charge readers for its content. We believe that industry news is important for you to do your job, and Quality Digest supports businesses of all types. However, someone has to pay for this content. And that’s where advertising comes in. Most people consider ads a nuisance, but they do serve a useful function besides allowing media companies to stay afloat. They keep you aware of new products and services relevant to your industry. All ads in Quality Digest apply directly to products and services that most of our readers need. You won’t see automobile or health supplement ads. So please consider turning off your ad blocker for our site. Thanks, James Michael Causey’s been a journalist since he started his own neighborhood newspaper in the 1970s. In addition to quizzing FDA officials for the past 10+ years, he’s also interviewed political satirist Art Buchwald, FCC Chairman Reed Hundt, SEC Chairwoman Mary Schapiro, and is the past president of the Washington Independent Writers. Causey is the editor and publisher of eDataIntegrityReport.com and is a contributing writer on the AssurXblog.FDA Pilot Program Encourages Quarterly Malfunction Summary Filings
Our PROMISE: Quality Digest only displays static ads that never overlay or cover up content. They never get in your way. They are there for you to read, or not.
Quality Digest Discuss
About The Author
Michael Causey
© 2022 Quality Digest. Copyright on content held by Quality Digest or by individual authors. Contact Quality Digest for reprint information.
“Quality Digest" is a trademark owned by Quality Circle Institute, Inc.