510(K) EXEMPTION FOR 164 CLASS I, TIER I DEVICES PROPOSED BY FDA

510(K) EXEMPTION FOR 164 CLASS I, TIER I DEVICES PROPOSED BY FDA in a July 21 Federal Register notice. The agency explains that the premarket notification requirements for the devices are "unnecessary" to protect the public health and says the exemptions "will allow the agency to make better use of its resources and thus better serve the public."

Under the three-tiered device "triage" program established last year, Tier I devices have the lowest risk and Tier III the highest. Devices selected for exemption were those that did "not have a significant history of false or misleading claims or of risks associated with inherent characteristics of the device."

FDA published the proposal in anticipation of enactment of device user fee legislation that was introduced on July 12 ("The Gray Sheet" July 18, p. 1). The bill stipulates that FDA must publish regulations identifying and exempting all appropriate Class I and Class II devices from 510(k) requirements before June 30, 1995 in order for the legislation to remain in effect. FDA plans to publish, later this year, a proposal for exempting Class II Tier I devices from 510(k) requirements.

Speaking at a July 19 Health Industry Manufacturers Association meeting in Arlington, Virginia, FDA Center for Devices and Radiological Health Director Bruce Burlington noted that Class I, Tier I devices represent approximately 10% of the application submissions received by the agency and Class II, Tier I devices constitute an additional 10%. However, Burlington cautioned against overestimating the workload reduction that CDRH will realize from the exemptions. He estimated that because of the minimal review Tier I products receive, CDRH would save only six full-time equivalent employees.

Broken down by category, the list of 164 devices slated for exemption from 510(k) requirements includes: seven clinical chemistry/clinical toxicology devices; six hematology/pathology devices; eight immunology/microbiology devices; five anesthesiology devices; one cardiovascular device; 38 dental devices; four ear, nose and throat devices; one gastroenterology- urology device; 16 general/plastic surgery devices; 13 general hospital/personal use devices; 14 neurological devices; 36 ophthalmic devices; five orthopedic devices; six physical medicine devices; and four radiology devices.

The proposed rule places limitations on 25 of the devices listed, requiring that they meet specific definitions to be eligible for 510(k) exemption. For example, stethoscopes must be either mechanical, manual or direct (acoustic) to be exempt from premarket approval, and nuclear scanning beds must be "labeled with weight limit, used with planar scanning only," and not used for x-ray diagnosis. Other products with special limitations include clinical sample concentrators, organ bags, keratoscopes, and non-prescription sunglasses.

Twenty-seven of the 164 devices also would be exempt, with limitations, from good manufacturing practice regulations. For example, rebreathing devices and articulation paper would be exempt from GMPs as long as they are "not labeled or otherwise represented as sterile." However, GMP provisions for maintaining records and complaint files must still be followed.