Archive for September 2020

It’s possible to learn from failures resulting in unacceptable risks for combination drug-device-biologic products what design input requirements are essential to the safe and effective operation and use of such products, Susan Neadle, head of combination products at Johnson & Johnson, said at the World Drug Safety Congress Americas. Source: The GMP Letter

Australia’s Therapeutic Goods Administration move to exempt from regulation certain classes of software-based medical devices that present a lower risk to safety drew broad support in written comments to the agency. Source: The GMP Letter

The FDA issued an update on adverse events related to breast implants, including breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), and breast implant illness. Source: The GMP Letter

The FDA has updated its policy on COVID-19 testing, clarifying that manufacturers of multi-analyte respiratory panels which include SARS-CoV-2 are now eligible for Emergency Use Authorization (EUA). Source: The GMP Letter

Failure to validate reprocessing instructions for its Class II reusable menstrual cups and a host of other quality issues landed Dot International a seven-item Form 483 following an FDA inspection of its Evanston, Illinois facility. Source: The GMP Letter

Process control procedures were found to be lax during an FDA inspection of Hudson Scientific’s Hudson, Michigan facility. Source: The GMP Letter

Failure to submit medical device reports to the FDA within the prescribed timeframe and lax complaint handling landed duodenoscope maker Olympus a Form 483 following an FDA inspection of its San Jose, California facility. Source: The GMP Letter

The FDA has granted Abbott Laboratories an Emergency Use Authorization for its COVID-19 antigen test, a diagnostic that provides fast, readable results on a card similar to some pregnancy tests. Source: The GMP Letter

Recalls in the medical device industry are a business activity — not just something that the regulatory and quality teams do. Source: The GMP Letter

The European Commission has established common specifications for reprocessing single-use devices under the EU Medical Device Regulation. Source: The GMP Letter