FDA Biocompatibility Tips: Multiple Absorbability, Allergenicity Testing Methods To Choose From
This article was originally published in The Gray Sheet
An FDA device reviewer and an agency toxicologist talk to The Gray Sheet about key industry considerations for biocompatibility testing, emphasizing a growing focus on testing absorbable implants and testing for allergens in devices.
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A podcast interview and a feature story delving into the recent international ISO 13485 quality systems standard revision were the most popular items at TheGraySheet.com last month. Our continuing coverage of off-label communication questions in the courts and the laboratory-developed test debate attracted attention, along with a piece on biocompatibility testing tips from FDA officials. Also: popular Gray Sheet podcasts from April.
CDRH Guidance Priorities Include Lab-Developed Tests, Adverse Event Reporting, Third-Party 510(k) Review
FDA's device center issued its annual “A List” and “B List” guidance priorities for fiscal year 2016, spotlighting efforts to address Unique Device Identification direct marking, Medical Device Reporting rules, laboratory-developed tests, 510(k) third-party review, companion diagnostics, and more.
FDA reviewers ask manufacturers to put novel materials in devices through additional testing beyond what is described in existing guidance documents.