CDRH Finalizes Guidance on Diagnostic Ultrasound Systems and Transducers

USA – FDA Releases 20 Years of Data on Medical Device Adverse Event Reports

The US Food and Drug Administration (FDA) recently ended its Alternative Summary Reporting (ASR) program for medical devices, revoked the related exemptions and on...
Drug and medical device highlights 2018: Helping you maintain and improve your health

Canada – Health Canada Consults on New Proposed Device Regulations

Health Canada on Friday launched a public consultation soliciting feedback on a set of proposed regulations intended to provide the agency with better safety...
Brazil’s ANVISA adjusts upcoming regulation for custom-made medical devices

Brazil – Brazil’s ANVISA adjusts upcoming regulation for custom-made medical devices

Brazilian medical device market regulator ANVISA recently discussed revisions to planned requirements for custom-made devices with Emergo by UL consultants prior to finalization and official publication...
FDA Received 6,000 Reports About Essure in 2018

USA – FDA Received 6,000 Reports About Essure in 2018

FDA recently updated its Essure website to include an analysis of medical device reports received in 2018. The agency said it received about 6,000 medical...
CDRH Drafts Guidance on Mouse Embryo Assays

USA – CDRH Drafts Guidance on Mouse Embryo Assays

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Wednesday called for comments on draft guidance to aid...
11 Medical Devices Recently Approved by FDA

USA – 11 Medical Devices Recently Approved by FDA

FDA has been busy this year in more ways than one. From warning the public about unauthorized devices,  banning summary reports for breast implants, to drafting...
The Best Predicate or the Worst?

USA – The Best Predicate or the Worst?

FDA’s 510(k) process requires the comparison of a candidate device to a similar device that is already legally marketable. The objective of this comparison...
FDA Revises 1999 Draft Guidance on Population Pharmacokinetics

USA – FDA permits marketing of first medical device for relief of pain associated...

The U.S. Food and Drug Administration today permitted marketing of the first medical device to aid in the reduction of functional abdominal pain in...
NESTcc Taps Apple Watch as First Wearable Project

USA – NESTcc Taps Apple Watch as First Wearable Project

The National Evaluation System for health Technology Coordinating Center’s (NESTcc) 12 new real-world evidence (RWE) test cases marked its first active surveillance project—the US...
GS1 Guideline Seeks to Help Implement FDA’s UDI Requirements

USA – GS1 Guideline Seeks to Help Implement FDA’s UDI Requirements

GS1 US recently updated its unique device identification (UDI) implementation guideline, with new instructions on device identifiers (DIs), production identifiers (PIs), human readable information...

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