Global Task Force Clarifies QMS Nonconformity Grading System
When evaluating devicemakers’ quality management systems, auditors should deem an initial nonconformity as one that has not been observed in two prior QMS audits, according to a Global Harmonization Task Force final guidance. The GHTF’s Study Group 3 released the guidance as part of a series of final issuances prior to its Jan. 1 transition to becoming the International Medical Device Regulators Forum. The change to two prior QMS audits from one, contained in a draft version of the guidance released November 2012, comes as the GHTF is urging auditors to increase specificity and accuracy in assessing comparable nonconformities and repeat risks. . . .
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FDA Rolls Out UDI Rule; Lays Out Key Deadlines for Devicemakers
The Office of Management and Budget has approved the FDA's long-awaited proposed rule on a unique device identifier (UDI), clearing it for release by the agency. The rule, once implemented, will provide the cornerstone for a modern postmarket device surveillance program. First proposed in the FDA Amendments Act of 2007, each UDI will include a device identifier, which encodes the device model, as well as a production identifier, which includes the device's batch or lot number and expiration date, if any. . . .
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The GHTF Document on Supplier Controls
Kim Trautman, FDA consumer safety officer and an expert on GMP, discusses the recommendations from the Global Harmonization Task Force SG3 guideline that outlines supplier controls. . . .
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