Minding The Middle: FDA Fleshes Out De Novo Regs As The Program Expands
A new proposed rule on the de novo classification process does not advance any major policy reforms, but its release underscores the growing popularity of the regulatory pathway that provides flexibility for US FDA and industry in the space between 510(k)s and PMAs.
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In mid-May a policy will kick in that requires all US agencies to send new rules and guidance documents to the Office of Management and Budget so it can determine whether they're "major" and should be voted on by Congress. Yet an FDA official said at MedCon 2019 on 2 May that the agency is still looking for more "clarity" on the subject. There are several draft guidances in the device center pipeline that will be affected by the OMB's oversight play.
Several experts suggest FDA is toeing the line in keeping the first stage of its pre-certification program for software-as-a-medical-device products legally permissible, but it may be limited in scope for the time being. Meanwhile, one attorney says the agency is sending mixed messages about whether the current program will sit comfortably within FDA's current authorities.
It was another record year for novel device approvals by US FDA, driven by the big uptick in de novo classifications for low-to-moderate-risk devices in 2018. Meanwhile, original PMA approvals dropped significantly. An analysis and infographic on FDA device approval trends in 2018.