FDA Related News

Medical Devices

FDA Clears Hybrid Sacroiliac Joint Implant

FDA clears a Spinal Simplicity 510(k) for the Patriot-SI Posterior Implant System as part of a hybrid sacroiliac joint fusion construct.

Federal Register

Guide on Public Health Emergency IVDs

Federal Register notice: FDA makes available a draft guidance entitled Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public...

Federal Register

Test Enforcement Policies During Emergency Guide

Federal Register notice: FDA makes available a draft guidance entitled Consideration of Enforcement Policies for Tests During a Section 564 Declared E...

Update Informed Consent Guidance: AdvaMed

AdvaMed calls for updates to FDA and HHS informed consent guidances.

Human Drugs

High-Concentration Humira Biosimilar OKd

FDA approves Boehringer Ingelheims high-concentration, citrate-free formulation of Cyltezo (adalimumab-adbm), an interchangeable biosimilar to Abbvies...

Federal Register

Info Collection on FDA Recall Regs

Federal Register notice: FDA sends to OMB an information collection extension entitled FDA Recall Regulations 21 CFR Part 7.

Federal Register

Listening Session on Advisory Committee Revamp

Federal Register notice: FDA announces a 6/13 virtual public meeting entitled Listening Session: Optimizing FDAs Use of and Processes for Advisory Com...

Medical Devices

QS Violations in Unapproved Spectrum Devices

FDA warns the UKs Spectrum Medical about QS violations in its production of unapproved perfusion system devices.

Medical Devices

VITEK 2 Antimicrobial Test Cards Recalled

BioMrieux recalls its VITEK 2 AST antimicrobial sensitivity testing cards due to a higher concentration of ceftriaxone antibiotic in two wells.

Federal Register

Draft Guide on Cell/Gene Therapy Considerations

Federal Register notice: FDA makes available a draft document entitled Considerations for the Use of Human- and Animal-Derived Materials and Component...