CDRH Guidance Priorities Include Lab-Developed Tests, Adverse Event Reporting, Third-Party 510(k) Review
This article was originally published in The Gray Sheet
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.
You may also be interested in...
US FDA has revised and expanded its 1996 guidelines on bone-anchor submissions. The revision discusses clinical and nonclinical testing standards for devices used to fasten tissue to bone, as well as other 510(k) concerns.
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.
The agency recently sat down with members of the Clinical Decision Support Coalition who presented mock case studies of regulatory submissions for software supporting drug therapy decisions. The coalition hopes to get feedback on how FDA intends to regulate such software in the coming months.