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Anaheim, California-based Anacom MedTek hadn’t established procedures for finished device acceptance, for acceptance of incoming product or for CAPA activities, an FDA inspection found. Read More
Multiple repeat deficiencies related to medical device reporting, CAPAs, validation procedures and acceptance activities were uncovered during an FDA inspection of General Medical Company’s Jacksonville, Florida manufacturing facility. Read More
Failure to establish procedures for design control and to document control procedures and acceptance activity procedures were just a few of the 483 observations cited for device specification developer and repackager Web 2U Com during an inspection of its Fort Lauderdale, Florida plant. Read More
The FDA will hold a March 5 public workshop on evaluation practices for virtual and augmented reality in medicine at the agency’s White Oak Campus in Silver Spring, Maryland. Read More
The FDA has released a new draft guidance that lays out a step-by-step process for applying data from a previously approved delivery system, a practice commonly known as bridging, to an application for a combination product. Read More
An FDA inspection of Medical Informatics’ Houston, Texas facility revealed lax complaint handling and a lack of medical device reporting procedures.
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Westwood Laboratories didn’t establish corrective and preventive action procedures for nonconforming products, according to a 483 received following an inspection of the firm’s Azusa, California plant.
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Algomedica’s Sunnyvale, California facility drew a Form 483 when an inspection revealed a pattern of failing to address root causes of nonconformance of its artificial intelligence algorithm PixelShine that analyzes CT scans. Read More
Health Canada has finalized guidance on software as a medical device (SaMD) that clarifies how it fits into the agency’s regulatory framework and how devicemakers can comply. Read More
Sens. Chuck Grassley (R-Iowa), Elizabeth Warren (D-Okla.) and three representatives urged the Centers for Medicare & Medicaid Service to begin including information from unique device identifiers (UDIs) for high-risk implants on electronic insurance claims. Read More