In two new guidances, the FDA calls for different types of information in 510(k) premarket submissions for blood glucose monitoring systems for use by healthcare professionals as compared to those…
A set of three guidance documents the FDA released Sept. 25 provides a look into the agency’s implementation of its new Accreditation Scheme for Conformity Assessment (ASCA) pilot program for…
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…
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…
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…
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…
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…
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.…