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Latest From Elizabeth Orr
Continuing recovery efforts in Puerto Rico have US FDA focused on life-sustaining devices or those only made on the island. Meanwhile, manufacturers including Baxter, Zimmer, J&J and Abbott report varying impacts from the storms.
NuVasive has sued a former executive and board member for breach of contract after his move to competitor Alphatec. The smaller company says the basis of the lawsuit is “fictional.”
A recent study by Sparta Systems revealed that more than four in 10 companies, including device-makers, still primarily handle customer complaints on paper, or via a decentralized system like Microsoft Excel or Access. Two quality assurance experts weigh in.
The US agency is looking for ways to open its upcoming Voluntary Medical Device Manufacturing and Product Quality Program – designed to gauge the manufacturing maturity of device-makers – to smaller firms, officials said at a recent industry meeting. Medtronic and Edwards Lifesciences, in particular, noted that using the Capability Maturity Model Integration (CMMI) appraisal framework could allow them to save hundreds of thousands of dollars in FDA submissions and 30-day notice fees, among other expenses.
US FDA's 14-page guidance, issued Oct. 2, outlines the agency’s recommendations for 510(k)s seeking clearance for the viewing units used in diagnostic radiology, finalizing a 2016 draft guidance.
Device-law attorney Jeffrey Gibbs answered caller questions during a Sept. 27 MassMedic webinar. Topics addressed include marketing, enforcement, and preparing for FDA meetings