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The FDA released draft guidance on the content and formatting of Instructions for Use (IFU) for drug- or biologic-device combinations.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Most comments on the FDA’s draft guidance for reclassifying surgical staplers supported the move to reclassify devices from Class I to Class II but some cautioned that the rule could…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…

The FDA has issued a final guidance on postmarketing safety reporting (PMSR) requirements for combination products. Source: The GMP Letter

With only nine months to go before the EU’s Medical Device Regulation hits its May 26 application date, the U.S. is pressing the EU to delay implementation for another three…