Shawn M. Schmitt
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Latest From Shawn M. Schmitt
Abbott, Merck Like FDA's Plan To Amass More Summary Adverse Event Reports, But P&G Says There's A Better Way
While mammoth manufacturers Abbott Laboratories and Merck & Co. – along with device industry advocacy groups – are supporting the US agency's proposed Voluntary Malfunction Summary Reporting Program, Procter & Gamble Co. is urging FDA to think twice. In comments to the agency, P&G's principal scientist says the program, which will allow firms to submit Medical Device Reports to FDA quarterly in a bundled format for a wide array of products, should be scrapped and replaced with an 11-year-old congressional mandate that aimed to boost summary reports.
Duodenoscope-makers Olympus, Fujifilm and Pentax Medical failed to conduct post-market surveillance study activities mandated by US FDA in 2015; quality systems violations noted at firms that make dental diagnostic X-ray devices and laser fiber-optic surgical devices. Six device-related warning letters were released by the agency this week.
FDA Warning Letters For Olympus, Fujifilm, Pentax: Duodenoscope-Makers Fail To Meet Agency's Post-Market Surveillance Study Order
US FDA sent the letters toOlympus Corp., Fujifilm Medical Systems USA Inc. and Pentax Medical after the firms failed to meet obligations to conduct Sec. 522 post-market studies on their duodenoscopes, the use of which caused a number of antibiotic-resistant superbug infections in 2013 and 2014.
Stakeholders criticized the US agency's plan to gather more adverse events in a summarized fashion under its proposed Voluntary Malfunction Summary Reporting Program. Ten commenters pleaded with FDA to reconsider its plan, while one industry attorney questioned why the agency never adhered to a 2007 congressional mandate that it collect more summary reports.
Following a major Supreme Court patent case in 2014 that set a test for what is and is not patentable subject matter, medical device companies are struggling to protect their software, which is often considered not patentable. In this week's Medtech Insight podcast, we discuss the legal hurdles and what companies can do to push back.
US FDA statistics shared with Medtech Insight show that the number of Medical Device Reports sent to the agency dramatically rose last year, both in individual and summary formats. Might the agency's upcoming Voluntary Malfunction Summary Reporting Program slow the overall number of MDRs this year?