Bone Anchors – Premarket Notification (510(k)) Submissions
Posts published in “United States Department of Health & Human Services – HHS”
FDA Issues Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests
FDA eSTAR Pilot Program
UPDATE: The FDA recommends performing contained morcellation in women when laparoscopic power morcellation is appropriate Draft guidance – Product Labeling for Laparoscopic Power Morcellators
Recommendations for Dual 510(k) and CLIA Waiver by Application Studies
Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices
Public Workshop – Using Patient Preference Information in Medical Device Regulatory Decisions: Benefit-Risk and Beyond
Cell Phone Safety: FDA Releases Literature Review, Web Page Updates
FDA Will Hold A Public Workshop to Discuss Good Simulation Practices in Health Technologies
Accreditation Scheme for Conformity Assessment (ASCA) – Annual Report 2019