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Zeiss PMA Approved for Astigmatism Patients

[ Price : $8.95]

FDA approves a Zeiss PMA for ReLEx Smile to expand myopia treatment to patients with astigmatism.

Docket No. Corrected on Dietary Supplement Notice

[ Price : $8.95]

Federal Register notice: FDA corrects the docket number in a 9/7 Federal Register notice announcing a draft guidance entitled Poli...

Info Collection Extension Sought for User Fee Forms

[ Price : $8.95]

Federal Register notice: FDA submits to OMB an information collection extension for Electronic User Fee Payment Request Forms For...

FDA Inspection Cites McKesson on Product Tracing

[ Price : $8.95]

A June FDA inspection of drug supplier McKesson results in a three-item Form 483 citing deficiencies with product tracing requirem...

Applied BioCode Gastro Pathogen Panel Cleared

[ Price : $8.95]

FDA clears an Applied BioCode 510(k) for its BioCode Gastrointestinal Pathogen Panel and its use with the high throughput BioCode ...

Grant Implanted Device Exception: WLF

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Washington Legal Foundation asks the Utah Supreme Court to recognize that implanted medical devices are unavoidably unsafe.

Device Coordinated Voluntary Disclosures Good: Analysis

[ Price : $8.95]

The Medical Device Innovation Consortium lists the many benefits arising from adoption of coordinated voluntary disclosure policie...

Comments Extended on Guide for Export Certificates

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Federal Register notice: FDA extends the comment period for a draft guidance entitled Process To Request a Review of FDAs Decision...

Comments Sought on Info Collection for INDs

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Federal Register notice: FDA seeks comments on an information collection extension entitled Investigational New Drug Application21...

CDRH Lists Guidance Docs for FY 2019

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Federal Register notice: FDA has announced the Web site location where it will post two lists of guidance documents that CDRH inte...