FDA Sends Rare CDRH Notice-Of-Opportunity-For-Hearing Letter
This article was originally published in The Gray Sheet
Executive Summary
FDA's issuance of a notice-of-opportunity-for-hearing letter (NOOH) to a prominent eye physician indicates the device center is moving forward with administrative procedures to examine whether his clinical investigator (CI) privileges should be revoked
You may also be interested in...
FDA Seeking Civil Penalties From Clinical Investigator Disqualified By CDRH
LaHaye Center for Advanced Eye Care of Lafayette, Louisiana will have until Dec. 20 to respond to an FDA administrative complaint filed Oct. 11
FDA’s New Dataset Aims To Assist Labs In Assessing Medical Device Biocompatibility
The US FDA’s device center has unveiled a new public dataset designed to assist chemistry laboratories in ensuring the robustness of chemical characterization methods used to assess the biocompatibility of medical devices.