Author Archive for Food and Drug Adminstration (FDA): CDRHNew
Brief Summary for the 11/16/06 Meeting of the Immunology Devices Panel
Closed Published by Food and Drug Adminstration (FDA): CDRHNew November 19th, 2006 in Regulatory AffairsThe committee will discuss, make recommendations, and vote on a premarket approval application for a laboratory assay designed for the rapid detection of clinically relevant (greater than 0.2 millimeters) metastases in lymph node tissue removed from…
Federal Register: Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting.
Closed Published by Food and Drug Adminstration (FDA): CDRHNew November 16th, 2006 in Regulatory AffairsThe FDA is announceing a forthcoming meeting of the Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee which will be open to the public.
Guidance for Industry, FDA Staff, and Third Parties - Provision for Alternate Measure of the Computed Tomography Dose Index (CTDI) to Assure Compliance with the Dose Information Requirements of the Federal Performance Standard for Computed Tomography
Closed Published by Food and Drug Adminstration (FDA): CDRHNew November 16th, 2006 in Regulatory AffairsThis document provides guidance to manufacturers and assemblers of x-ray computed tomography (CT) equipment and to FDA staff.
Breast Implants Information - Approval of Allergan and Mentor Silicone Gel-Filled Breast Implants (11/17/2006)
Closed Published by Food and Drug Adminstration (FDA): CDRHNew November 16th, 2006 in Regulatory AffairsTopics: Breast Implants, Breast Prostheses, Key Websites, Silicone
Guidance for Industry - Medical Device Tracking; Guidance for Industry and FDA Staff
Closed Published by Food and Drug Adminstration (FDA): CDRHNew November 16th, 2006 in Regulatory AffairsThe Food and Drug Administration Modernization Act (FDAMA) requires that manufacturers track certain devices when the agency orders them to do so. Tracking is intended to facilitate notification and recall in the event a device presents a serious risk…
Guidance for Industry and FDA Staff - Saline, Silicone Gel, and Alternative Breast Implants
Closed Published by Food and Drug Adminstration (FDA): CDRHNew November 16th, 2006 in Regulatory AffairsThis guidance document identifies the device description, preclinical, clinical, and labeling information we recommend you present in a premarket approval application (PMA) for a breast implant. This guidance document may also be useful in preparing an…
Summary Information for: Inamed® Silicone-Filled Breast Implants
Closed Published by Food and Drug Adminstration (FDA): CDRHNew November 16th, 2006 in Regulatory AffairsPDF format only. Topics: Breast Implants
Summary Information for: Mentor MemoryGel? Silicone Gel-Filled Breast Implants
Closed Published by Food and Drug Adminstration (FDA): CDRHNew November 16th, 2006 in Regulatory AffairsPDF format only. Topics: Breast Implants
Guidance for Industry and FDA Staff - Exemption from Certain Reporting and Recordkeeping Requirements for Microwave Ovens
Closed Published by Food and Drug Adminstration (FDA): CDRHNew November 15th, 2006 in Regulatory AffairsUnder Title 21 of the Code of Federal Regulations §1002.50 (21 CFR 1002.50), FDA may exempt manufacturers of electronic products from reporting and recordkeeping requirements subject to any conditions necessary to protect the public health…
Guidance for Industry and FDA Staff - Exemption from Certain Reporting and Recordkeeping Requirements for Television Receivers and Computer Monitors with Cathode Ray Tubes
Closed Published by Food and Drug Adminstration (FDA): CDRHNew November 15th, 2006 in Regulatory AffairsUnder Title 21 of the Code of Federal Regulations §1002.50 (21 CFR 1002.50), FDA may exempt manufacturers of electronic products from reporting and recordkeeping requirements subject to any conditions necessary to protect the public health…
Federal Register: Proposed Collection; Comment Request; Agreement for Shipment of Devices for Sterilization
Closed Published by Food and Drug Adminstration (FDA): CDRHNew November 14th, 2006 in Regulatory AffairsThe FDA isannouncing an opportunity for public comment on the proposed collection of certain information by the agency on requirements relating to shipment of nonsterile devices to be sterilized elsewhere or are shipped to other establishments for further
Federal Register: Submission for Office of Management and Budget Review; Medical Device User Fee and Modernization Act Small Business Qualification Certification (Form FDA 3602)
Closed Published by Food and Drug Adminstration (FDA): CDRHNew November 14th, 2006 in Regulatory AffairsThe FDA is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Dental Products Panel Advisory Meeting - November 9, 2006 (Added Brief Summary)
Closed Published by Food and Drug Adminstration (FDA): CDRHNew November 13th, 2006 in Regulatory AffairsThe committee will discuss, make recommendations, and vote on a premarket approval application for a collagen material, which contains a bone morphogenetic protein, for oral maxillofacial bone grafting procedures. Background information, including the…
Summary Information for: Endotex Interventional Systems, Inc. Endotex® Nexstent® Carotid Stent and Delivery System and Endotex® Carotid Stent and Monorail® Delivery System
Closed Published by Food and Drug Adminstration (FDA): CDRHNew November 13th, 2006 in Regulatory AffairsPDF format only. Topics: Stents
Summary Information for: Nidek EC-5000 Excimer Laser System
Closed Published by Food and Drug Adminstration (FDA): CDRHNew November 13th, 2006 in Regulatory AffairsPDF format only. Topics: LASIK
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Archive for Food and Drug Adminstration (FDA): CDRHNew.
Food and Drug Adminstration (FDA): CDRHNew
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