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FDA Clears Cepheid Xpert TV Test

[ Price : $8.95]

FDA clears a Cepheid 510(k) to market Xpert TV, a qualitative in vitro diagnostic test for identifying Trichomoniasis in symptomat...

Downing Labs Recalls Compounded Products

[ Price : $8.95]

Downing Labs recalls all lots of sterile products compounded and packaged by the firm due to concerns over sterility assurance.

Prize Competition to Further Open Science

[ Price : $8.95]

The National Institutes of Health announces a global competition to find new products or services to advance open science.

Comments Sought on Supplement AERs/Recordkeeping Info

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on a collection of information associated with adverse event reporting and recordkeepi...

Comments Sought on Requesting CDRH Review of Decisions

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on information collection associated with processes for stakeholders to request additi...

Comments Sought on Device Inspection Accredited Persons

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on a collection of information on device inspections by accredited persons.

Guidance on Device Manufacturing Site Change Supplements

[ Price : $8.95]

Federal Register Notice: FDA releases a draft guidance: Manufacturing Site Change Supplements: Content and Submission.

Coronary Vascular Simulation Software into Class 2

[ Price : $8.95]

Federal Register Final order: FDA classifies the coronary vascular physiologic simulation software device into Class 2.

23andMe Gains Clearance for Controversial Genetic Test

[ Price : $8.95]

FDA clears 23andMes Personal Genome Service, a controversial genetic test that was as the center of a CDRH regulatory action two y...

FDA Needs Updated Regulatory Framework: Patient Group

[ Price : $8.95]

Friends of Cancer Research founder Helen Sigal says FDAs regulatory framework for drugs and devices needs to be updated to reflect...