FDA to Exempt Dozens of Devices from Premarket Requirements
The FDA is exempting 120 device types from premarket notification requirements after determining they pose little risk to users.
In final guidance issued July 1, the agency says it doesn’t intend to enforce compliance with 510(k) requirements for these devices, which fall into the Class I, Class II or unclassified categories, and won’t require devicemakers to submit 510(k)s for these devices.
Among the devices are certain oscillometers, teething rings and medical support stockings. The decision comes as part of the agency’s commitment under the reauthorization process for the Medical Device User Fee Amendments.
Based on a comment on the August 2014 draft guidance, the FDA added product code OYS, patient bed with canopy or restraints, to the exemption list. As it finalized the guidance, the agency identified an additional 15 device types for the list.
The FDA also determined that two device types in the draft guidance — certain thermometers and cranioplasty plates — should still be subject to 510(k)s.
On thermometers, the agency notes that the devices treat a range of conditions, including screening for potential pandemic contagious diseases.
Cranioplasty plates warranted stricter controls because they are permanent implants and may be constructed of polymeric materials, which could be resorbable, the FDA says.
Because some manufacturers of these two device types may not have submitted a 510(k) as a result of the draft guidance, the agency’s Center for Devices and Radiological Health will give them 90 days following the publication of the Federal Register notice to submit an application.