Thegmpletter

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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Most comments on the FDA’s draft guidance for reclassifying surgical staplers supported the move to reclassify devices from Class I to Class II but some cautioned that the rule could adversely affect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FDA Issues Draft Guidance on Labeling of Combination Products

The FDA released draft guidance on the content and formatting of Instructions for Use (IFU) for drug- or biologic-device combinations.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