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Federal Register

Info Collection Extension for CLIA Categorizations

Federal Register notice: FDA sends to OMB an information collection extension entitled Administrative Procedures for Clinical Laboratory Improvement A...

Federal Register

Latest Federal Register Notices

FDA Review posts the Federal Register notices for the week ending 10/25/2019.

FDA General

Since Our Last Issue ...

Industry news you may have missed since our last issue.

Federal Register

Orthopedic Surgical Instruments Put Into Class 2

Federal Register notice: FDA classifies orthopedic surgical instrumentation designed for osteochondral implants with press-fit fixation into Class 2 (...

Federal Register

Draft Guide on Homeopathic Drug Products

Federal Register notice: FDA makes available a revised draft guidance entitled Drug Products Labeled as Homeopathic.

Federal Register

Allergan NDA Lo Minastrin FE Withdrawn

Federal Register notice: FDA withdraws the NDA approval of Allergan Pharmaceuticals Lo Minastrin FE because it is no longer marketed.

Federal Register

Internal Therapeutic Massagers Put Into Class 2

Federal Register notice: FDA classifies internal therapeutic massagers into Class 2 (special controls).

Medical Devices

FDAs Growing Concern on Device Sterilization

FDA grows concerned over recent closures of certain large-scale sterilization facilities that use ethylene oxide to sterilize medical devices prior to...

Medical Devices

Impella Heart Pump Study Confirms Survival Data

Abiomed says that a post-approval study confirmed survival data in its pre-approval study for the Impella RP heart pump.

Federal Register

Five Class 2 Devices Exempt from 510(k)

Federal Register notice: FDA announces its decision to exempt a list of Class 2 devices from premarket notification requirements.