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The FDA has cited Zoll Manufacturing for failing to adequately validate its Class III medical Life Vest, noting that “approximately half of all treatments delivered to patients are inappropriate shocks,” according to a recent warning letter. Read More
The FDA has warned Ambco Electronics after the devicemaker failed to correct deficiencies noted during a California Department of Public Health inspection and an earlier FDA inspection. Read More
The FDA unveiled a broad plan that will change the way it inspects devicemakers, handles recalls, issues and reviews enforcement decisions and screens imports, with companies likely to start feeling the impact by the end of 2015. Read More
Western Enterprises/Scott Fetzer Company received an FDA warning letter after averaging its suppliers’ quality ratings with its delivery ratings, resulting in a higher overall rating for some suppliers. Read More
Devicemakers seeking authorization to market Class II products in Canada will need to submit labeling with their licensing applications, under draft guidance released Oct. 20. Read More
Manufacturers of low- and moderate-risk devices will soon be able to register their products in Australia based on CE mark certificates issued by European notified bodies, under a government action plan introduced this month. Read More
The Centers for Medicare & Medicaid Services is willing to pay for Myriad Genetics’ Prolaris prostate cancer test via a local coverage determination proposed by a South Carolina Medicare contractor. Read More
The FDA issued a final rule Wednesday placing nucleic acid-based IVDs for the detection of Mycobacterium tuberculosis complex in Class II with special controls. The rule also covers use of the tests to detect genetic mutations associated with MTB complex antibiotic resistance in respiratory specimens. Read More
International medical device regulators are trying to entice more companies to participate in a single-audit pilot program, promising they will receive no warning letters unless the issues pose an immediate threat to public health.
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Industry groups are warning the FDA that its draft guidance on risks versus benefits in 510(k) submissions could trigger new requirements for clinical trials that are inconsistent with the premarket notification process. Read More