Human Factors: Information for Consumers, Patients, and Caregivers

Using Medical Devices at Home

• Home Use Devices
• Learn if a Medical Device Has Been Cleared by FDA for Marketing
• Additional Resources on Home Use Devices

How to Report Problems with Medical Devices

Please help us keep safe, effective and high-quality medical products available on the market by reporting any adverse events and product problems you have with these products. Your report may be the critical one that encourages a company to change the use or design of the product, makes the product safer to use, and/or increases patient safety.

• Reporting Online (complete and submit an electronic form)
• Reporting [Suspected] Unlawful Sales of Medical Products on the Internet

Post-Market Reporting

• Medical Device Reporting (MDR) – Contact Information for User Facilities and Manufacturers
• Medical Device Reporting (MDR): How to Report Medical Device Problems
• Postmarket Reporting by Health Professionals