Detailed article at MedCityNews, here. Genomeweb here. AND: The FDA's press release, here. Coverage at Sidley, including links to the FDA final orders and a concurrent comment request, here.
See recessive carrier screening downclassification order, 82 FR 51567, here. See also 82FR51560, here, and a Request for Comment on downclassification processes, 84FR51633, here. (Comment due by 1/8/2017). I've put these in one cloud zip file, here.
Update 6/5/2018: See also final downclassification order, June 5, 2018, here. This specifically closes out 84FR51633, as cited above.
Flagged Online at FDA on September 26
Gottlieb actually flagged this Pre-Cert approach clearly in late September, but few picked up on it. See my blog entry on September 26, here. In a speech at Advamed, which was reported by MedCityNews and others at the time, Gottlieb said that "we need some legislation" on LDTs.
However, if you dug around on the FDA website at the time, you could see the "official prepared remarks" -- which were a little different from the actual speech. Here's what we found at the time.
In the "official prepared remarks," online at FDA.gov, Gottlieb had a script for talking about the newly released "pre cert" process for digital health software, and was to have remarked verbally that this would be a "basis for a modern legislative approach" to LDTs. However, this sentence didn't appear to occur in his verbal remarks from the Advamed podium.
For an FDA press release on the Digital Health Software Pre Certification Program, see here. The FDA will hold a January 30-31, 2018 conference on Precertification (here).
FDA's Key Text Released November 6
Returning to the new genetic health risk (GHR) framework, here's a quote from the new FDA press release:
Today, the FDA is taking steps to implement a novel regulatory approach for the regulation of GHR tests that applies proper oversight in a flexible, new way. It builds on the important lessons we learned from the FDA’s authorization of the first GHR and carrier screening tests sold directly to consumers. Specifically, today the agency issued a notice of its intent to allow GHR tests to be exempted from premarket review under certain conditions. If and when finalized, manufacturers of these types of tests would have to come to FDA for a one-time review to ensure that they meet the FDA’s requirements, after which they may enter the market with new GHR tests without further review. The agency also established special controls for these tests in a separate de novo classification order, which outline requirements for assuring the tests’ accuracy, reliability and clinical relevance and describe the type of studies and data required to demonstrate performance of certain types of genetic tests. This approach is similar to the proposed firm-based, pre-certification model that we developed for digital health technologies.
These Important Wheels Starting Turning in February 2015
Note that this process builds on groundbreaking approaches to genetic test policy created for 23andMe a couple years ago. We described this as a sea-change in the FDA's approach to molecular approvals in a deep dive essay back in February 2015.
