FDA publishes final rule on de novo pathway for medium risk devices

The US Food and Drug Administration has now published its final rule on the de novo pathway for medical device clearance, clarifying the requirements for manufacturers whose devices may need to use the route in future. The 84-page final rule includes only minor changes from the 2018 draft rule.

The pathway is used by manufacturers of medium risk devices using new technology for which no legally-available predicate devices exist, thus preventing the new device from following the normal marketing clearance pathway for medium risk devices, this being the 510(k) submission route.

Publication of the final rule has meant that four other guidance documents have needed to be updated, these being:

De Novo Classification Process (Evaluation of Automatic Class III Designation): Guidance for Industry and Food and Drug Administration Staff, accessible from here;

Acceptance Review for De Novo Classification Requests: Guidance for Industry and Food and Drug Administration Staff, accessible from here;

FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals: Guidance for Industry and Food and Drug Administration Staff, accessible from here; and

User Fees and Refunds for De Novo Classification Requests: Guidance for Industry and Food and Drug Administration Staff, accessible from here.

The changes are slated to take effect from 3 January 2022.