Industry Assistance

• Combination Products
• Device Advice
• OIVD’s eSubmission [Turbo 510(k)] Program
• Electronic Copies Program
• 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
• 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 • Risk Communication Advisory Committee Meeting, February 28 - February 29, 2008 • FDA / NHLBI / NSF Workshop on Computer Methods for Cardiovascular Devices, March 18-19, 2008 • Certification to Accompany Drug, Biological Product, and Device Applications or Submissions • FY 2006 CDRH Annual Report Public Health Notifications: • Unretrieved Device Fragments • Patient Burns from Electric Dental Handpieces • Deaths reported following Radio Frequency Ablation of Lung Tumors • Vail Products Enclosed Bed Systems Class I Medical Device Recalls - • Medtronic Inc. SynchroMed EL Implantable, Infusion Pump • AM2 PAT Inc. Pre-Filled Heparin Lock Flush Syringes and Normal Saline IV Flush Syringes (All Lots and All Sizes) • Cordis Corporation Dura Star™ RX and Fire Star™ RX PTCA Balloon Catheters • Cardinal Health Alaris® Infusion Pump module (formerly Medley™ Pump module), Model 8100 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
• Reprocessing of single-use devices
• Unique Device Identification

Radiological Health

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

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Center for Devices and Radiological Health / CDRH