Industry Assistance

• Combination Products
• Device Advice
• Electronic Submissions / eCopies
• Guidance documents
• Importing in the U.S.
• Industry Support
• International issues
• Medical device reporting (MDR)
• Getting market clearance / approval
• Ombudsman
• Standards
• Third party review
• Third party inspection

Health Topics

• Consumer information
• Medical Devices in emergency situations
• FDA & You Newsletter
• Maturity Health Matters
• Recent device approvals
• FDA Patient Safety News
• Recalls
• Reporting problems
• Public Health Notifications
• Home Health Care Committee

About CDRH

• Advisory committees
• Medical Device Fellowship Program
• Job information
• Outside Leveraging
• Meetings and presentations
• Organizational information
• Strategic planning
• Office of Science and Engineering Laboratories

News & Events Rapid Lead Screening Test FDA Statement on Coronary Drug-Eluting Stents FDA Public Meeting on Unique Device Identification, October 25th, 2006 Federal Communications Commission (FCC) Seeking Information About Present and Future Uses of Radio Transmitters in Medical Devices Class I Medical Device Recalls - • Medtronic SynchroMed EL Programmable Infusion Pumps FDA Patient Safety News - A Video News Show for Health Professionals View All Recent Website Additions

Device Program Areas

• Clinical Laboratory
  Improvement Amendments
• Compliance activities
• Device evaluation information
• FDA Modernization Act
• Good manufacturing practice
• Human Factors
• In Vitro Diagnostic Devices
• Medical Device User Fee
  and Modernization Act of 2002
• Postmarket initiative
• Postmarket surveillance
• Registration and listing
• Reuse of single-use devices

Radiological Health

• Radiological Health Program - New Directions
• Amendments to Performance Standard for Diagnostic X-ray Systems
• Cell phone facts
• Electronic product and
  radiation control
• Mammography program
• Radiation-emitting products
• Technical electronic product
  radiation safety standards committee
• Whole body CT scanning
• Wireless medical telemetry

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