Date Issued: July 13, 2011 Audience: Health care providers who implant surgical mesh to repair pelvic organ prolapse and/or stress urinary incontinence Health care providers involved in the care of patients with surgical mesh implanted to repair pelvic organ prolapse and/or stress urinary incontinence Patients who are considering or have received a surgical mesh implant…
CDRH Learn (New Course Available
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Summary Information for: Elecsys® Anti-HBc Immunoassay and Elecsys® PreciControl Anti-HBc for use on the E170 MODULAR ANALYTICS
Issued June 22, 2011 Approval Order Summary Labeling Other Consumer Information This document is in a Portable Document Format (PDF). Acrobat Reader is required to read this document. Updated July 1, 2011
Minutes from Negotiation Meeting on MDUFA III Reauthorization: June 17, 2011
FDA – Industry MDUFA III Reauthorization Meeting June 17, 2011, 10:00 – 4:30 pm FDA Switzer Building, Washington, DC Room 1007 Purpose To discuss FDA’s response to Industry’s June 1 alternative proposal, and approaches for mitigating program uncertainty. Participants Meeting Start Time: 10:15 am FDA Presentation FDA offered its response to Industry’s June 1, 2011…
Draft Guidance for Industry and Food and Drug Administration Staff
DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Document issued on: July 12, 2011 You should submit comments and suggestions regarding this draft document within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit written comments to the Division of Dockets…
Influenza Virus Vaccine for the 2011
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Biologic Product Shortages
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Evaluation of Automatic Class III Designation (De Novo) Decision Summary: K093937
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Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology Devices; Availability
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Draft Guidance for Industry and Food and Drug Administration Staff
DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Document issued on: July 14, 2011 You should submit comments and suggestions regarding this draft document within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit written comments to the Division of Dockets Management…