Consumer Information on: Gel-One®

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Public Workshop – Reprocessing of Reusable Medical Devices, June 8

The Food and Drug Administration (FDA) is announcing a public workshop to discuss factors affecting the quality of reprocessing of reusable medical devices, and FDA’s plans to address the identified issues. This workshop is part of an ongoing FDA effort to address patient exposure to inadequately reprocessed reusable medical devices with the overall goal to [...]

PMA Final Decisions for March 2011

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Information on Reprocessing of Reusable Medical Devices

Reusable medical devices are devices that health care providers can reuse to diagnose and treat multiple patients. Examples of reusable medical devices include surgical forceps, endoscopes and stethoscopes. When used on different patients, reusable devices become soiled and contaminated with microorganisms. To avoid any risk of infection by a contaminated device, reusable devices undergo “reprocessing,” [...]

Evaluation of Automatic Class III Designation (De Novo) Decision Summaries (Added K101699)

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Draft Guidance for Industry and FDA Staff

DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Document issued on: May 2, 2011 Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.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 Management [...]

Natural Disaster Response

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Public Workshop

The Food and Drug Administration (FDA) is announcing a public workshop of Study Methodologies for Diagnostics in the Postmarket Setting. The purpose of the workshop is to provide a forum for discussion among FDA, governmental agencies, academia, physicians and various stakeholders with expertise in epidemiology, statistics, diagnostics and biomedical research to advance the methodologies for [...]

Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes (New Memos Available)

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Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes (New Memos Available)

<!– –> <!– Page Last Updated: 04/25/2011 –> Page Last Updated: 04/25/2011 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Article source: http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHTransparency/ucm206289.htm