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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
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Industry groups are warning the FDA that its draft guidance on risks versus benefits in 510(k) submissions could trigger new requirements for clinical trials that are inconsistent with the premarket notification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
With investigators from the U.S. Food and Drug Administration set to begin scrutinizing UDI compliance, Class III devicemakers should ensure that UDI changes in their design history files are adequately documented and that a verification process for barcodes is in place. Read More
As EU notified bodies begin conducting the unannounced audits required by the European Commission, devicemakers need to make sure they have at least two employees who are prepared to handle an audit. Read More
As notified bodies in the EU conduct the first wave of unannounced quality audits of devicemakers, they are building profiles of the companies to determine when and how often they are inspected in the future. Read More
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 Tuesday 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