U.S. Food and Drug Administration - Center for Devices and R
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International issues Medical device reporting (MDR) Getting market clearance / approval Ombudsman Standards STED Pilot Program Third party review Third party inspection Health Topics Consumer information MedicalDevices in emergency situations FDA & You Newsletter Maturity Health Matters Recent device approvals FDA Patient Safety News Recalls Repor...
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http://www.fda.gov/cdrh/index.html
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U.S. Food and Drug Administration - Center for Devices and R
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International issues Medical device reporting (MDR) Getting market clearance / approval Ombudsman Standards STED Pilot Program Third party review Third party inspection Health Topics Consumer information MedicalDevices in emergency situations FDA & You Newsletter Maturity Health Matters Recent device approvals FDA Patient Safety News Recalls Repor...
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http://www.fda.gov/cdrh/
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Subscribe to Free E-mail Lists
Releases Recalls & Alerts Podcasts [what is a podcast?] Drug Safety Patient Safety News (with Videos) What's New by Topic Food Drugs MedicalDevices Biologics Animal Feed & Drugs Radiation-Emitting Devices Cosmetics Toxicological Products Regulatory Affairs Title Content Frequency FDA News Digest FDA activities News for consumers, industry and heal...
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http://www.fda.gov/emaillist.html
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MedWatch - 2007 Safety Information Alerts
Biologics - Special Nutritional Products and Cosmetics - Drugs and Therapeutic Biologics - MedicalDevices -- or -- Click on "Go To Most Recent" to view the medical product safety summaries in reverse chronological order, starting with the most recent. Go To Most Recent What's This tegaserod maleate) (Posted 03/30/2007) Ziagen (abacavir...
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http://www.fda.gov/medwatch/safety/2007/safety07.htm
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How to Report Problems With Products Regulated by FDA
18, 2006 What products does FDA regulate? Why should I report? How do I report an emergency? How do I report non-emergencies about: Food Medical Products: Medicines, MedicalDevices, Blood Products, Biologics, Special Nutritionals Vaccines Blood Transfusions and Donations Animal feed Veterinary Products Cosmetics Products Sold Online What should I ...
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http://www.fda.gov/opacom/backgrounders/problem.html
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Food and Drug Administration, Center for Devices and Radiolo
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21 CFR 1040.11(c) for a Laser Light Show, Display, or Device Sean M. Boyd 240-276-3287 3417 03/07 Medical Device Reporting- Baseline Report- Part 1 {Instructions} William Huff 240-276-3463 3419 06/03 Medical Device Reporting Annual User Facility Report {Instructions} William Huff 240-276-3463 3422 01/05 Government Entity Declaration Susan Bradt 301...
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http://www.fda.gov/opacom/morechoices/fdaforms/CDRH.html
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Medical Device User Fee and Modernization Act of 2002 (MDUFM
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Medical Device User Fee and Modernization Act of 2002 (MDUFMA) FDA Home Page | Search FDA Site | FDA A-Z Index fees for device reviews. Establishment inspections may be conducted by accredited persons (third-parties), New regulatory requirements for reprocessed single-use devices. Summary of the Law PDF (67.6 KB) Complete Text of the Law PDF (172 ...
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http://www.fda.gov/oc/mdufma/default.htm
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FDA Requests Recall of All Shelhigh Medical Devices
FDA Requests Recall of All Shelhigh MedicalDevices FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA FDA News FOR IMMEDIATE RELEASE P07-78 May 2 Drug Administration (FDA) today issued a formal written request to Shelhigh, Inc. to recall all of its medicaldevices remaining in the marketplace, including hospital inventories, because of...
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http://www.fda.gov/bbs/topics/NEWS/2007/NEW01625.html
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Information About Medical Devices in Emergency Situations
Information About MedicalDevices in Emergency Situations FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH Information About MedicalDevices in Emergency Situations Pandemic Flu Personal Protective Equipment and Influenza Outbreaks, including Bird Flu (Avian Influenza) Hurricanes Disposal of Contaminated Advice About Reopeni...
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http://www.fda.gov/cdrh/emergency/index.html
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FDA/CBER - Devices
FDA/CBER - Devices FDA Home Page CBER Home Page CBER A-Z Index CBER Site Map Contact CBER What's New Allergenics Blood Cellular & Gene Scientific Expertise & Research Print Page | Devices The Center for Biologics Evaluation and Research (CBER) regulates the medicaldevices involved in the collection, processing, testing, manufacture and admini...
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http://www.fda.gov/cber/devices.htm
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Freedom of Information Act
Contact CDRH | Accessibility | Disclaimer FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page Center for Devices...
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http://www.fda.gov/cdrh/foicdrh.html
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MedWatch - How to report serious adverse events
Human Cell, Tissues and Cellular and Tissue-Based Products (HCT/P) Adverse Reaction Reporting Submitting mandatory investigational new drug (IND) reports Medical Device Manufacturers, Distributors, and User-facilities Download Mandatory Reporting Form 3500A (PDF format) Information about medical device reporting This CDRH page provides contact info...
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http://www.fda.gov/medwatch/how.htm
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Outside Leveraging
OL Project Team Training Conclusions Appendices Lessons Learned Examples of Leveraging in Regulatory Agencies (Mini Case Studies) Collaboration with Orange County Medical Device Network OSHA"Maine Top 200 " EPAs 33/50 Program: From Confrontation to Collaboration FDA Success Stories Other FDA Sites FDA Leveraging Contact CDRH | Accessibility | D...
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http://www.fda.gov/cdrh/leveraging/
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Medical Device User Fee and Modernization Act of 2002 (MDUFM
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Medical Device User Fee and Modernization Act of 2002 (MDUFMA) FDA Home Page | Search FDA Site | FDA A-Z Index fees for device reviews. Establishment inspections may be conducted by accredited persons (third-parties), New regulatory requirements for reprocessed single-use devices. Summary of the Law PDF (67.6 KB) Complete Text of the Law PDF (172 ...
Url:
http://www.fda.gov/oc/mdufma/
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Electromagnetic Compatibility
Electromagnetic Compatibility FDA Home Page | CDRH Home Page | Search | A-Z Index EMC Home What is CDRH's Role? Wireless Medical Telemetry Guidance Recognized Standards Articles Other Resources FDA > CDRH > Electromagnetic Compatibility & Wireless MedicalDevices > Home Electromagnetic Compatibility - EMC Electromagnetic compatibility , or EMC mean...
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http://www.fda.gov/cdrh/emc/index.html
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FDA Modernization Act
Contact CDRH | Accessibility | Disclaimer FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page Center for Devices...
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http://www.fda.gov/cdrh/modact/modern.html
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Food and Drug Administration Home Page
Google A-Z Index Site Map Products FDA Regulates Food Foodborne Illness, Nutrition, Dietary Supplements Drugs Prescription, Over-the-Counter, Generic MedicalDevices Pacemakers, Contact Lenses, Hearing Aids Biologics Vaccines, Blood Products Animal Feed and Drugs Livestock, Pets Cosmetics Safety, Labeling Radiation-Emitting Products Cell Phones Tr...
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http://www.fda.gov/
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Manufacturer and User Facility Device Experience Database (M
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Experience Database (MAUDE): File Formats for FOI Releasable Data FDA Home Page | CDRH Home Page | Search | A-Z Index FDA > CDRH > Medical Device Reporting > Manufacturer and User Facility Device Experience Database - (MAUDE) Manufacturer and User Facility Device Experience Database - (MAUDE) File Formats for 21 CFR 803.19. An on-line search is av...
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http://www.fda.gov/cdrh/maude.html
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Recent Device Approvals
Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH Recent Device Approvals Welcome to FDA's information about medical device approvals. The following information is available: New Device Approvals that include some of the newest medical technology available. Monthly listings of Premarket Notification [510(k)] and Premarket Approval...
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http://www.fda.gov/cdrh/consumer/mda/index.html
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