Trish Landry, SVP Clinical Operations
Authored By: Trish Landry
SVP Clinical Operations

The Beaufort team was a proud sponsor of The Association of Medical Device Manufacturers (AMDM) Fall IVD Focus Meeting held last week (Oct 19-20) in Los Gatos, CA.

Here are several highlights from the 2023 meeting:

FDA Update On LDT Proposed Rule Changes

On September 29, 20203, the FDA released a Proposed Rule for assuring the Safety & Efficacy of Laboratory Developed Tests (LDTs). This proposal will represent a dramatic shift and phaseout of FDA’s general enforcement discretion approach to LDTs. The AMDM presentation provided an overview of the guidance included the following discussion items:

Last week, FDA announced a webinar to be held on Tuesday, October 31st to review the guidance as outlined above as well as answer questions. You can register here:

Software Submission Best Practices

2023 FDA Software Guidance includes a more rigorous look at risk classifications: Risk to the user and patient. For IVDs, software is reviewed as a test system. Tables below, presented by Karen Bijwaard, MS, RAC, MB(ASCP), CQA (CDRH/OPEQ/OHT7/DMGP), show the differences between the 2005 FDA Guidance and the 2023 FDA Guidance language.

New FDA Voluntary Pilot Program for Oncology Drug Products

FDA announced a voluntary pilot program for Industry with the objective of obtaining/providing greater transparency of minimum performance characteristics that certain tests for certain oncology drugs should meet. This pilot program will not alter the standards for the approval of oncologic drug products or for the marketing authorization of the corresponding companion in vitro diagnostics. FDA Guidance Document was published on 20 Jun 2023.

Additional Meeting Takeaways

Contact us today to discuss how any of these issues impact your business – and see how we can help you bring your IVD product successfully through the changing regulatory landscape.

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