Simplifying Global Compliance
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August 2019
No. 475
Headlines
Full Issue of The GMP Letter in PDF Format
Download and view the full issue. Read More
U.S. Urges EU to Delay Implementing EU MDR/IVDR by Three Years
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 years. Read More
FDA Finalizes Guidance on Postmarketing Safety Reporting for Combination Products
The FDA has issued a final guidance on postmarketing safety reporting (PMSR) requirements for combination products. Read More
FDA Warns Clinicon for Lax Testing, Validation of Sterilization Processes
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 Oceanside, California facility. Read More
Industry Supports Reclassification of Surgical Staplers, But Adds Caution
Most comments on the FDA’s draft guidance for reclassifying surgical staplers supported the move to reclassify devices from Class I to Class II but some cautioned that the rule could adversely affect access to the products. Read More
FDA Issues Draft Guidance on Labeling of Combination Products
The FDA released draft guidance on the content and formatting of Instructions for Use (IFU) for drug- or biologic-device combinations. Read More
483 Roundup: FDA Cites Five Firms for Complaints, Validations
The FDA rapped five devicemakers for a variety of violations including complaint handling, validations and failure to establish procedures for process changes. Read More
FDA Warns of Security Holes in Medtronic’s Insulin Pumps
Certain models of Medtronic’s MiniMed insulin pumps have potential cybersecurity risks and should be swapped out for newer models, the FDA advised. Read More
Canada Issues New Premarket Requirements for Cybersecurity
Health Canada has issued new guidance on its premarket requirements for medical device cybersecurity. Read More
France Issues EU’s First Cybersecurity Guidelines
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. Read More
