USA – FDA proposes long-awaited LDT enforcement rule
The US Food and Drug Administration (FDA) has published a much-anticipated proposed rule that aims to end its enforcement discretion of laboratory-developed tests (LDT)...
USA – FDA premarket cybersecurity guidance clarifies SBOM requirements
The US Food and Drug Administration (FDA) has published a premarket cybersecurity guidance almost a decade in the making. The document adds requirements based...
USA – Considerations for the Conduct of Clinical Trials of Medical Products During Major...
This guidance recommends approaches that sponsors of clinical trials of medical products can consider when there is a major disruption to clinical trial conduct...
USA – FDA guidances keep coming, new device harmonization plan, and more
Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical...
USA – Biocompatibility Testing of Medical Devices – Standards Specific Information for the Accreditation...
This guidance provides information on how the Biological Evaluation of Medical Devices standards are incorporated into the Pilot Accreditation Scheme for Conformity Assessment Program...
USA – FDA weight-loss device guidances address clinical and non-clinical studies
A decade in the making, the US Food and Drug Administration (FDA) has published two complementary draft guidances for sponsors developing weight-loss devices. The...
USA – FDA’s final breakthrough devices guidance now includes technologies that address health disparities
Final guidance on the US Food and Drug Administration breakthrough device program includes new language noting that the program now can be used to...
USA – FDA updates medical device biocompatibility guidance with exclusion list
The US Food and Drug Administration (FDA) has updated its guidance on biocompatibility issues medical device sponsors should consider in their premarket submissions. This...
USA – Use of International Standard ISO 10993-1, « Biological evaluation of medical devices –...
FDA has developed this guidance document to assist industry in preparing Premarket Applications (PMAs), Humanitarian Device Exceptions (HDEs), Investigational Device Applications (IDEs), Premarket Notifications...
USA – Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions
As part of FDA’s Medical Device Safety Action Plan: Protecting Patients, Promoting Public
Health (herein referred to as the “Safety Action Plan”),1 FDA committed to...
