Last November, FDA announced it planned to make some genetic tests self-certifying, that is, 510(k) exempt. The proposed rule appeared November 7, 2017 (here). The final rule appeared June 5, 2018 (here).
An Exemption "After" First Review
The exemption applies somewhat confusingly to future 510(k)s after a specific test device has received a one time review by FDA. Yes, a naive reader might think it's more of a "510k revision exemption" than a "510k exemption."
The FDA discussed in the new June 2018 rulemaking that it received "one comment" on its proposal - an objection - although the corresponding Regulations.gov webpage lists "0 public comments" (here). The comment, dealt with in Q&A format as is usual, was from "a professional organization opposing [the] exemption." It would be interesting to know which organization this was or why it's comment isn't available at regulations.gov.
Exemption from 510(k) Followed Downclassification from Class III to Class II
The June 2018 finalization was largely a "coda" to events last November, such as the downclassification from Class III to Class II of the 23andMe personal genome service test (aka Genetic Health Risk Assessment System, per new FDA category 866.5950).
The Class III to Class II de novo 23 page review is here and an FDA press release here. Note that these are for DTC tests.
Lengthy Analytical Validity Requirements in Regulation
FDA argues that full analytical validation is established by following stated regulations (see 21 CFR 866.5950(b)(3)(iii)). FDA allows the self-certification with four limitations. The health-risk tests cannot be any of these: (1) indicated for prenatal testing, (2) predisposition to cancer where the may lead to confirmatory treatments or procedures, (3) genetic variants that impact drug metabolism, (4) assessment of autosomal dominant variants.
The device regulation category 866.5950 is 4700 words long; most FDA classification categories are only several words long.
Neither Cleared nor Approved?
Some CMS rules refer to "cleared or approved" tests, such as the spring 2018 NCD on genomic tests in cancer. Tests that are self-certified under novel types of FDA regulations or potentially under novel lawmaking might not be pigeon-holed as either "cleared or approved" but rather in a different gray space as "authorized."
Trade Press Links
For more information see:
- June 2018: RAPS, MobiHealth, Becker's,
- March 2018: WSJ.
- November 2017: STAT, Duke.
- The DUKE article gives a detailed listing of the initially authorized genes and a bullet point description of the extensive controls.