Abbott Labs
This article was originally published in The Gray Sheet
Executive Summary
June 30 petition to FDA requests exemption of triiodothyronine uptake test systems (21 CFR 862.1715) from premarket notification requirements. Interested parties are allowed under Sec. 206 of FDAMA to make such a request, to which the agency must respond by 180 days or the petition is deemed granted. Abbott points to a literature search revealing that the devices, which have been in use for more than 30 years, do not have a significant history of false or misleading claims, nor do they have a significant history of risks associated with their use