Houston-based medical devicemaker Talon received a lengthy FDA warning letter for design process and quality control issues following an inspection of the firm’s manufacturing facility. Source: The GMP Letter
The International Medical Device Regulators Forum (IMDRF) has issued a new draft document on harmonizing terminology and codes for reporting adverse events for medical devices and in vitro diagnostics. Source:…
Devicemakers have raised concerns about the European Commission’s proposed specifications for reprocessing single-use devices. Source: The GMP Letter
France’s National Agency for Safety of Medicines and Health Products released new cybersecurity recommendations for medical devices designed to minimize the risk of cyber attacks. Source: The GMP Letter
Health Canada has issued new guidance on its premarket requirements for medical device cybersecurity. Source: The GMP Letter
Certain models of Medtronic’s MiniMed insulin pumps have potential cybersecurity risks and should be swapped out for newer models, the FDA advised. Source: The GMP Letter
The FDA rapped five devicemakers for a variety of violations including complaint handling, validations and failure to establish procedures for process changes. Source: The GMP Letter
The FDA released draft guidance on the content and formatting of Instructions for Use (IFU) for drug- or biologic-device combinations. Source: The GMP Letter
Most comments on the FDA’s draft guidance for reclassifying surgical staplers supported the move to reclassify devices from Class I to Class II but some cautioned that the rule could…
The FDA issued a June 20 warning letter to Clinicon for quality system lapses related to its SureProble Class II sterile probe following an April 3-4 inspection of the firm’s…