Jan 8, 2020

The US Food and Drug Administration published two final orders pertaining to device classifications and pathways to market. Additionally, it announced a new contract with Dun & Bradstreet to verify manufacturer registration and listing information.

Finalization of device exemptions

The first final order provides a long list of Class I and Class II devices that are exempt from premarket notification requirements. The compilation of this list was mandated under the 21st Century Cures Act, which requires the FDA to actively identify device types that no longer need 510(k) clearance. The list has been published previously, but this final order amends the language used in classification regulations. It additionally stipulates limitations to the exemption. This order went into effect on December 30, 2019.

Down-classifications for CES devices

Another final order adjusts the classification and premarket requirements for two types of cranial electrotherapy stimulator (CES) devices. CES devices used to treat insomnia or anxiety, which were previously listed as preamendments Class III, are down-classified to Class II with special controls, requiring 510(k) premarket notification. The FDA will issue a new product code for these devices. The order also stipulates that CES devices used to treat depression (product code JXK) will now require either premarket approval (PMA) or a notice of completion of a product development protocol (PDP). They additionally must have a device description that indicates that these are prescription devices. Several comments to the proposed rule argued that CES devices used to treat depression posed little health or safety risk and should be down-classified to Class II as well, but the FDA disagreed with this judgement and opted to maintain their Class III status. The order went into effect on December 20, 2019.

Third-party verification plans

Finally, the FDA announced that it has contracted the services of Dun & Bradstreet “to perform onsite verification of medical device facility information provided to the agency by registered and listed medical device manufacturers.” This information includes a facility’s Data Universal Numbering System (DUNS) number, physical address, establishment type, and products manufactured. If Dun & Bradstreet receives information that a company not registered with the FDA is involved in the manufacture of medical devices, it may also contact them. The FDA states that participation in these verification activities is voluntary and can save manufacturers time and expense.

Related US FDA regulatory information from Emergo: