Category: Medical Device

USA: FDA Drafts Guidance on Patient Engagement in Device Trials

September 27, 2019
Medical Device

The US Food and Drug Administration (FDA) has published draft guidance on how device manufacturers should engage patients when designing medical devices. This Draft Guidance is Intended...

China: NMPA Joins IMDRF’s Post-Market Device Safety Data Exchange Scheme

September 27, 2019
Medical Device

The China National Medical Products Administration (NMPA) has joined the International Medical Device Regulators Forum’s (IMDRF) national competent authority report (NCAR) exchange program. NCAR supports...

Uncertainty as a Factor in Determining Benefit-Risk for Pre-market Approval of Medical Devices

September 5, 2019
Medical Device

With the recent announcement from FDA’s Center for Devices and Radiological Health (CDRH) about their finalization of guidelines towards accepting a higher premarket uncertainty with regards to the...

European Medicines Agency Seeks Public Opinion on Draft Guideline on Quality Requirements for Medical Devices

June 26, 2019
Medical Device

European Medicines Agency has released a draft guideline on the quality requirements for medical devices in human medicines that include a medical device, known as drug-device combinations, for a 3-month...