Test Anxiety: FDA Issues Warning Letters to Test Laboratories
The Food and Drug Administration (FDA) recently issued warning letters to two third-party nonclinical testing laboratories. The FDA cited the laboratories for “oversight failures and animal care violations that raise...
Dr. Jeff Shuren, FDA CDRH Director, to Retire
On July 23, 2024, Dr. Jeff Shuren, the director for the Center for Devices and Radiological Health (CDRH), announced that he will retire. Dr. Shuren became director of the CDRH...
FDA Dataset Helps Firms Scrutinize Third-Party Chemistry Labs
Medical devices that contact the human body undergo biocompatibility safety assessments prior to market release, including tests for physiochemical properties. The Food and Drug Administration’s (FDA) Center for Devices and...
Orthobond Received FDA De Novo Approval for Antibacterial Technology
Orthobond received on April 5th de novo approval for the company’s spinal fusion device with quaternary ammonium compound coating. Orthobond’s antibacterial treatment, Ostaguard™, covalently bonds its antimicrobial, polycationic molecules to...
Expect Future FDA Clarification on Machine Learning-Enabled Medical Devices
The inaugural AAMI/FDA neXus medical device standards conference was held February 20-23, 2024 in Washington DC. The conference was hosted by the Association for the Advancement of Medical Instrumentation (AAMI)....
FDA Issues Warning about Fraudulent and Unreliable Laboratory Data
The U.S. Food and Drug Administration (FDA) recently issued a Letter to Industry warning medical device manufacturers and device study sponsors (“device firms”) of a source of “fraudulent and unreliable...
Updates in the FDA’s Regulation of Digital Health Technologies
The FDA issued a warning letter to Abiomed, for failing to seek approval for its Impella Connect System software before putting it on the market. The Impella Connect System software...
Shutdown will Impact FDA
The looming government shutdown will likely slow the pace of work at the FDA. The federal government will shut down on October 1, 2023 unless a deal is reached. In the event...
