FDA Related News

Medical Devices

medPhoton ImagingRing CT Scan Cleared

FDA clears a medPhoton 510(k) for the ceiling-mounted ImagingRing, an in-room cone-beam computed tomography imaging system.

Medical Devices

Arthrosurface Toe Fixation Cleared by FDA

FDA clears an Arthrosurface 510(k) for its BOSS Toe Fixation System for stabilizing the first metatarsal that presents with a distal bone void.

Medical Devices

FDA Wants Weight Loss Device Feedback

FDA seeks comment on a discussion paper on how to determine and consider benefit and risk in weight-loss medical devices.

Human Drugs

Seizure Drug Efficacy Extrapolation Guidance

FDA issues a guidance on clinical development of drugs to treat partial onset seizures in pediatric patients over age two.

Combination Product Labeling Contents

Three stakeholders suggest changes to an FDA draft guidance on instructions for use in combination product labeling.

Human Drugs

Too Few Antibiotics in Development: Pew Report

A Pew Charitable Trusts issue brief says there are not enough new antibiotics in the development pipeline to meet the need.

Federal Register

Info Collection Extension for PET Drug GMPs

Federal Register notice: FDA has submitted to OMB an information collection extension for positron emission tomography Drug GMPs.

FDA General

Sharpless Supporters More Vocal

Supporters of FDA acting commissioner Ned Sharpless urge the administration to nominate him as permanent commissioner.

Federal Register

Panel to Discuss Duodenoscope Sterilization

Federal Register notice: FDA announces an 11/6-7 Advisory Committee meeting to discuss industrial ethylene oxide sterilization of medical devices, inc...

Human Drugs

Chromatographic Bioanalysis Guidance

FDA issues a guidance to make recommendations to sponsors, applicants, and contract research organizations on internal standard response variability i...