October 18, 2021
The US Food and Drug Administration (FDA) has made several regulatory updates affecting De Novo classification of novel medical devices; Global Unique Device Identification Database (GUDID) submission requirements for low-risk devices; and up-classification of surgical staple products to Class II (moderate risk).
Final rule for De Novo classification process
First, FDA has published a final rule for the agency’s De Novo classification process whereby manufacturers of innovative devices may obtain US market authorization . Effective January 3, 2022, the final rule includes a new section, Subpart D, to address De Novo classification request formatting and content requirements. Subpart D also lays out FDA procedures for accepting and reviewing De Novo requests.
The final rule also includes new definitions related to De Novo requests, general versus specific controls and classification regulations.
De Novo classification request applicants should also be aware of changes to the final rule’s Confidentiality of Information as well as Data sections; further details and updates are available via FDA’s De Novo Classification Request webpage.
Class I medical devices and GUDID submission requirements
Second, new FDA draft guidance explains the agency’s plans not to enforce GUDID submission requirements for low-risk Class I devices such as consumer health products, which are sold directly to consumers online or over the counter in retail stores. These devices’ lables already feature Universal Product Codes (UPC), which FDA may already accept in lieu of Unique Device Identification (UDI) codes for Class I devices.
FDA will accept stakeholder comments on the draft guidance until December 13, 2021.
Up-classification of surgical staplers
Third, the agency has published final orders to reclassify surgical stapler devices intended for internal use from Class I to Class II, effectively requiring 510(k) clearance for these products. The final rule took effect October 8, 2021.
Manufacturers of surgical staplers currently marketed as Class I devices in the US have 180 days from October 8 to obtain 510(k) clearance and meet associated special controls required by FDA.