Very Brief Blog: FDA Releases 20-page Device De Novo 510K Proposal

As FDA promised in recent weeks, it has released new policymaking that would update and codify the existing de novo classification process.  De novo requests have risen from 22 in 2012 to 100 in 2017.

• The published copy of the rulemaking is online here.  83 FR 63127-46, 12/7/2018.  
• Comment is open for 90 days (March 7).
• See a detailed pre-release discussion by MedTech Dive here.
• Press at Genomeweb here.  News at RAPS, here.   
• Nice review at Forbes by Yiannis Mouratidis, here.

Rules will be placed at 21 CFR 860.1, and under a new Subpart D to Section 860 when finalized.

In part, FDA states that the new rulemaking will increase the clarity and efficiency of the process, and (my reading) place into formal regulations some rules that may be similar to various prior guidances (some of which which FDA cites).  Regulations also have the force of law, which guidance documents do not have.

The de novo process dates to 1997 and was "streamlined" in 2012 by allowing direct classification of some new devices into the de novo process, no longer requiring a rejected 510(k) application.   My sense is that FDA has proceeded for years by policymaking by "guidance" and "process" and has not kept 510(k) or "de novo" regulations up to date.  (See here; for more background here and here).  Here, FDA dusts off 1998 regulations lost to the sands of time at 21 CFR 860 and updates them to reflect current statute and processes.

See the 17 page October 2017 De Novo guidebook here.

Context

Class II Exempt-from-Review Changes

In other 510(k) news this year, FDA published rules regarding when Class II devices would be exempted from review in June 2018 (final rule 83 FR 25910), here. 

This includes some direct to consumer genetic risk tests used for wellness purposes, for example.   See FDA's regulatory classification for genetic risk tests at 21 CFR 866.5950 (issued November 7, 2017, revised June 5, 2018), here.  FDA received at least one comment that it was making genetic test review too easy.

Last Week's News: Making 510(k) More Rigorous

Today's FDA regulation on 510(k) de novo is separate from a press announcement on November 26 that FDA would seek to toughen up 510(k) predicate usage, here.   Takeaway: To the extent that 510(k) predicate usage is made more rigorous, more tests would be shunted into the 510(k) de novo pathway.   So they are trying to oil the path for de novo before those new devices are shunted into it.

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Forbes author Mouratidis recently reviewed AI in pharma trials, here.