Regulatory Roundup: Hemostatic Sponges; Dental Implants, Wheelchair Elevators
This article was originally published in The Gray Sheet
Executive Summary
FDA downclassifies nonabsorbable expandable hemostatic sponges and blade form endosseous dental implants from class III to class II. A petition is submitted to exempt wheelchair lifts from 510(k)s.
You may also be interested in...
Experts Recommend Downclassifying Absorbable Collagen Hemostatic Devices Despite Data Doubts
A panel of experts recommended the US Food and Drug Administration downclassify certain absorbable collagen hemostatic devices despite concerns there isn't sufficient clinical data to support the safety and efficacy of the surgical products.
Regulatory Briefs: Dental Panel, Push For UDI Rule, Social Media Software
FDA’s Dental Devices panel recommends downclassifying dental implants. Health care groups urge OMB to release UDI final rule. FDA says it is looking to purchase a social media monitoring and measurement software tool.
Lack Of Industry Involvement In 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.