Another Important Guidance Document: Risk & Benefit

Tuesday, September 20, 2011

Also on August 15th the FDA issued Draft Guidance for Industry and Food and Drug Administration Staff – Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Review.

Again, I’d like to thank the Agency for making my job just a little bit easier. This document is well-written and provides a very nice worksheet and examples for considering risk vs. benefit. In particular I like the ‘case-study’ format and believe this will make it easier to explain issues particularly to the un-initiated.

The case-study that is used for IVDs is a product that I like to refer to as a pan-cancer diagnostic. A product designed for early detection of cancer in the general healthy population but has only been tested on patients already diagnosed with cancer. This scenario discusses the benefits and risks for this type of device as well as the problem with studying a device intended for screening of healthy patients in a population that only includes those already diagnosed.

This may seem like a far-fetched example but I’ve been approached by more than one company considering development of very similar products and wondering how FDA would regulate this type of device. The need for an outcome study (collecting enough samples and follow-up data to actually prove this claim) has stymied more than one CEO. As far as the use of retrospective samples to prove this type of claim … please see these previous blogs: Guidance Document Mania and Perils of Time Travel.

Another nice aspect of this document is that FDA makes it clear what it does not consider when establish risk and benefit – for example how much it would cost to do an appropriate trial or how long it takes to develop a product. I’m sensitive to both these points after spending most of a day last week arguing with a project team that tight corporate timelines should not be presented to the FDA as the reasons for a 510(k) instead of a PMA.

This guidance document is well worth the time to study (and I’ll be utilizing the worksheets) if you’re currently in development on an IVD or another type of device. It could provide unique clarity and possibly alter some development plans.


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