Interesting discussion on this important topic – Summary International Expert Meeting on breast implant-associated lymphoma
Medical Device Expert News
MDCG 2018-8 – Guidance on Content of the certificates, voluntary certificate transfers
Nonbinding Feedback After Certain FDA Inspections of Device Establishments
Topics to be discussed: breast implant associated anaplastic large cell lymphoma (BIA-ALCL); systemic symptoms reported in patients receiving breast implants; the use of registries for…
Consultation: Proposed regulatory scheme for personalised medical devices, including 3D-printed devices
Consultation: Regulation of software, including Software as a Medical Device (SaMD)
Interesting reads regarding a surgical mesh (in particular in view of the recent discussion on the Bleeding Edge and Implant files): 2019 Meeting Materials of…
Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements
Businesses supplying medicines and medical devices – what to expect on day one of a ‘no deal’ scenario
Statement from Binita Ashar, M.D., of the FDA’s Center for Devices and Radiological Health on agency’s continuing efforts to educate patients on known risk of…