MEDIcept Insights
Part 1 of 3 — Making Amends in Clinical Investigation Requirements: Aligning FDA Regulations with the Common Rule – Comment Period Extended until December
On September 28, 2022, FDA released two proposed rules aimed at amending some sections of its current regulations on human subject protections and Institutional Review Boards (IRBs) with the revised Federal Policy for the Protection of Human Subjects—also known as the...
‘Scorecard’ By Notified Body BSI Affixes Mediocre ‘Yellow' Designation To Second Half Of E.U.’s 19-Point MDR/IVDR Compliance Plan (2 Of 2)
When it comes to the medtech space implementing the second half of a 19-point action plan from the Medical Device Coordination Group, it’s pretty much yellow – or slow – across the board. At least that’s the assessment by notified body BSI Group. The MDCG’s plan,...
International Group ICH Offers Detailed Protocol Template For Clinical Trials
In a recently released draft guidance document, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) describes general protocol design principles and approaches used to develop relevant documents for clinical...
New FDA ‘TAP’ Pilot Wants To Help Companies Traverse ‘Valley Of Death’ By Streamlining The Product Clearance Process. First Up: Cardiovascular Devices
Makers of cardiovascular devices can navigate the dreaded “valley of death” for their unmarketed products by playing in an upcoming pilot program from the U.S. Food and Drug Administration (FDA) that will allow for earlier and more frequent engagement between...
Seeing Red (And Yellow): Notified Body BSI’s ‘Scorecard’ Shows Plenty Of Work Needed To Meet E.U.’s 19-Point MDR/IVDR Compliance Plan (1 Of 2)
The Medical Device Coordination Group released in August a 19-point action plan that the MDCG says will make sure medical products can be certified to the E.U.’s new MDR and IVDR regulations within prescribed transition time frames. The Position Paper, MDCG 2022-14,...
Gimme ‘MORE’: U.K.’s MHRA Wants Adverse Events From Device Makers Via ‘New’ MORE Portal
The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) on Oct. 6 told medical device manufacturers that beginning next month they must send post-market vigilance reports via the MHRA’s “new” Manufacturer's On-line Reporting Environment (MORE) portal. As...