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Federal Register

Comments Sought on Device Tracking Collection

Federal Register notice: FDA seeks comments on an information collection extension request for Medical Devices; Device Tracking 21 CFR Part 821.

14 Observations in Meridian Medical Inspection

FDA releases an FDA-483 with 14 observations from an inspection at Pfizers Meridian Medical Technologies facility that manufactures combination drug/d...

Medical Devices

Instrumentation Lab Gains 510(k) Clearance for Assay

FDA clears an Instrumentation Laboratory 510(k) for the HemosIL AcuStar HIT-IgG(PF4-H) Assay and HemosIL AcuStar HIT Controls.

Medical Devices

Slammed by Patients, CDRH Launches Patient Input Effort

Under fire from injured patients, CDRH gains commissioner Scott Gottliebs praise for a pioneering patient engagement effort in a new advisory committe...

Federal Register

Certain Devices for Detecting Microbial Pathogens into Class 2

Federal Register notice: FDA classifies nucleic acid-based devices for the amplification, detection, and identification of microbial pathogens directl...

Human Drugs

AstraZenca sBLA for Imfinzi in Lung Cancer

FDA accepts for priority review an AstraZeneca supplemental BLA for Imfinzi (durvalumab) for treating certain patients with locally advanced, unresect...

Federal Register

Class 2 Designation for Microbial Image Assessment Systems

Federal Register notice: FDA classifies automated image assessment systems for microbial colonies on solid culture media into Class 2 (special control...

Medical Devices

QS Violations in Kelynian Global Inspection

FDA warns Kelynian Global about Quality System and other violations in its manufacturing of custom cranial implants.

Medical Devices

Diasol Gets 3rd Warning Letter in October

FDA warns the third Diasol facility this month about Quality System and other violations in its manufacturing of liquid and powder sodium bicarbonate ...

Human Drugs

GDUFA Reauthorization Aids Public Health: FDA Execs

CDER executives say that GDUFA reauthorization helps public health by providing funds for the Centers work to bring generic drugs to market more quick...