FDA exemption of Class I, Tier I devices
This article was originally published in The Gray Sheet
Executive Summary
Several firms submit comments on the recently published FDA proposal to exempt 164 devices from 510(k) review. Urging that unscented menstrual pads be added to the group of exempted devices, Nancy Buc, lawyer for the Washington, D.C. firm Buc, Levitt & Beardsley, says that "if ever a product warranted an exemption, this is it." Coltene/Whaledent opposes the proposed exemption of retentive and splinting pins and root canal posts. Eliminating premarket notification requirements, the firm argues, would "result in substandard products being made available" that would become "part of permanent dental restorations, wreaking havoc on the...American public." The firm says that it manufactures a number of dental pins and posts that are preamendment devices as well as an active post under 510(k) clearance
You may also be interested in...
Sanofi Skates To Where The Puck Is With Immunology
The French drugmaker has not abandoned oncology but has made it very clear that immunology and inflammation is the priority for its R&D euros.
Pipeline Watch: Five Approvals And 23 Phase III Updates
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
Lack Of Industry Involvement In EU HTA Scoping Process Exacerbates ‘Unworkable’ Timelines
Scientific advice could help companies make up for the lack of involvement in scoping, but slots are in short supply.