Industry Assistance

• CDRH Learn
• Combination Products
• Device Advice
• OIVD’s eSubmission [Turbo 510(k)] Program
• Electronic Copies Program
• Electronic Clinical Data
• Guidance documents
• Importing in the U.S.
• Industry Support
• 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
• Medical Devices in emergency situations
• FDA & You Newsletter
• Maturity Health Matters
• MedSun: Medical Product Safety Network
• Recent device approvals
• FDA Patient Safety News
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• 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 • FDA/AdvaMed Workshop: Gender Differences in Cardiovascular Device Trials, December 9, 2008 Public Health Notifications: • Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence • Radiofrequency Ablation of Lung Tumors - Clarification of Regulatory Status Class I Medical Device Recalls - • Animas Corporation, Battery Caps Used with the OneTouch Ping System, Animas 2020 Insulin Pump, Animas IR1200 Insulin Pump, and Animas IR1250 Insulin Pump • Tyco Healthcare Group LP (Covidien), ReliOn Insulin Syringes, 1cc, 31-Gauge • VIBE Technologies, Vibrational Integrated Bio-photonic Energizer (VIBE) Machine Multi-Frequency Field Generator • Nebion, LLC HLX-8 Magnetic Resonance Device • Medtronic Neuromodulation INDURA One-Piece (IP) Intrathecal Catheters, Sutureless Pump Connector Revision Kit, and Intrathecal Catheter Pump Segment Revision Kit 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
  (Laboratory Tests)
• Medical Device User Fees
• Postmarket initiative
• Postmarket surveillance
• Registration and listing
• Reprocessing of single-use devices
• Unique Device Identification

Radiological Health

• FDA Radiological Health Program
• Mammography program
• Whole body CT scanning
• Medical Imaging

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