FDA Related News

FDA Warns About Some Genetic Test Predictions

FDA warns against using results from many genetic tests to predict how a patient will respond to a specific medication.

Federal Register

Class 2 for Meprobamate Test System

Federal Register notice: FDA classifies the meprobamate test system into Class 2 (special controls).

Medical Devices

De Novo Marketing for Pharmacogenetic Reports

FDA permits the de novo marketing of 23andMes Personal Genome Service Pharmacogenetic Reports as a direct-to-consumer test for providing information a...

Federal Register

Insulin Therapy Adjustment Devices into Class 2

Federal Register notice: FDA classifies insulin therapy adjustment devices into Class 2 (special controls).

Federal Register

2 Medical Device Proposed Rules Scrapped

Federal Register notice: FDA withdraws two proposed medical device rules after determining that they are not currently considered viable candidates fo...

Medical Devices

Improve FDA Cybersecurity Risk Policies, Procedures: OIG

The HHS Inspector General recommends ways FDA can improve its policies and procedures to address medical device postmarket cybersecurity risks.

Medical Devices

FDA Looking at Balloon Pump Shutdowns

FDA says it is evaluating over 75 reports of battery shutdown and other issues with Maquet/Datascope intra-aortic balloon pumps.

Medical Devices

FDA Clears OsteoRemedies Spectrum GV Hip Spacer

FDA clears an OsteoRemedies 510(k) for the Remedy Spectrum GV Hip Spacer System and Spectrum GV Bone Cement, which are intended to provide surgeons wi...

Human Drugs

Heron Therapeutics NDA for HTX-011

Heron Therapeutics files an NDA for HTX-011, a long-acting, extended-release formulation of the local anesthetic bupivacaine in a fixed-dose combinati...

Medical Devices

Cell Phone Safety Limits Remain Acceptable: Shuren

CDRH director Jeffrey Shuren says current cell phone radiofrequency exposure limits are acceptable to protect the public health.