Class II device 510(k) exemptions granted
This article was originally published in The Gray Sheet
Executive Summary
Triiodothyronine uptake test systems (21 CFR 862.1715) and film dosimetry systems, a.k.a. film scanning systems (892.5050) are exempted from FDA premarket notification requirements effective Jan. 8. The exemption for the film dosimetry system is limited only to systems intended for quality control use, the agency says in a same-day Federal Register notice. FDA's actions come in response to previous requests submitted by Abbott Labs and Radiological Imaging Technology, respectively. The two petitions are the first to be approved by FDA under procedures mandated by the FDA Modernization Act. Five have been denied by the agency ("The Gray Sheet" Dec. 7, 1998, In Brief)
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