VALID Act Fails to Pass – What to Expect for the Future of LDT Regulation
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)...
Understanding FDA’s New Guidance Document on Human Factors Information in Medical Device Submissions
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...
Understanding FDA’s Draft Guidance Document on Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers
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...
European Union Clinical Trials Regulation: Mandatory Deadline Approaching
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
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...
Part 2 of 3 — Making Amends in Clinical Investigation Requirements: Aligning FDA regulations with the Common Rule – Comment Period Extended until December
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...