Medicines and Medical Devices Bill: overarching documents
Posts published in February 2020
FDA eSTAR Pilot Program
So new draft agendas were published for some of the next MDCG meetings. Here are some topics that caught my attention (besides the important general…
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The FDA recommends performing contained morcellation in women when laparoscopic power morcellation is appropriate Draft guidance – Product Labeling for Laparoscopic Power Morcellators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
MANUAL OF THE WORKING GROUP ON COSMETIC PRODUCTS (SUB- GROUP ON BORDERLINE PRODUCTS) ON THE SCOPE OF APPLICATION OF THE COSMETICS REGULATION (EC) NO 1223/2009…
Regulation impact statement: Proposed regulatory scheme for personalised medical devices, including 3D-printed devices
Public Workshop – Using Patient Preference Information in Medical Device Regulatory Decisions: Benefit-Risk and Beyond