Statement from Jeffrey Shuren, M.D., J.D., Director of the FDA’s Center for Devices and Radiological Health, on new steps to help reduce risks associated with…
Posts published in April 2019
dCharacterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devicehttps://www.fda.gov/media/95791/downloads
State-of-play of joint assessments of Notified Bodies in the medical device sector
Unique Device Identification: Convenience Kits
Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions
April 2019 update of the MDR and IVDR implementing measures rolling plan
Commission Regulation (EU) 2019/319 of 6 February 2019 amending Annex IX to Regulation (EC) No 999/2001 of the European Parliament and of the Council and…
As can be seen in the ISO 13485:2016 page on the ISO website – the standard is under systematic review. Systematic review is required for…
FDA Invites You to the 2019 Regulatory Education for Industry (REdI) Annual Conference
Technical Performance Assessment of Quantitative Imaging in Device Premarket Submission