In-house medical devices are exempted from most of the provisions of (EU) 2017/745 (Medical Devices Regulation) and (EU) 2017/746 (In Vitro Diagnostic Medical Devices Regulation), given that the health institution follows the conditions laid out in Article 5(5) of the...
Regulatory reform of Laboratory Developed Tests (LDT) has been a long time in the making, but lawmakers and industry groups alike are debating to what degree of oversight is appropriate. Legislation called the VALID (Verifying Accurate Leading-edge IVCT Development)...
Human Factors Engineering is a crucial part of ensuring the safety and effectiveness of medical devices. Human factors testing is valuable when designing device/user interfaces. To help manufacturers understand the extent of human factors (HF) information required in...
Medical device reporting (MDR) is an important post-market activity that helps to ensure patient safety. The FDA receives over two million medical device reports annually, with malfunctions accounting for most reports received. The Voluntary Malfunction Summary...
Since 2004, clinical trials in the EU have been controlled by the European Union Clinical Trials Directive (EU-CTD). The directive was an attempt to standardize rules and enhance patient protections in clinical trials; however, its real-life implementation created...
Part 3 of 3 — Making Amends in Clinical Investigation Requirements: Aligning FDA Regulations with the Common Rule – Comment Period Extended until December In Part 2 of this series, we discussed FDA’s first proposed rule, “Protection of Human Subjects and Institutional...
In Part 1 of this series, we discussed the basic summary of FDA’s two proposed rules involving human subject protections and IRBs, as well as the extension FDA made to allow for commenters to have more time to develop thoughtful responses to the proposed rules. Part 2...
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...
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,...
In a recently released draft guidance document, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) describes general protocol design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...