Postmarket Requirements (Devices)

Medical device manufacturers as well as other firms involved in the distribution of devices must follow certain requirements and regulations once devices are on the market. These include such things as tracking systems, reporting of device malfunctions, serious injuries or deaths, and registering the establishments where devices are produced or distributed. Postmarket requirements also include postmarket surveillance studies required under section 522 of the act as well as post-approval studies required at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application.

Spotlight

• Guidance Documents (Medical Devices and Radiation-Emitting Products)
• Radiation-Emitting Products
• National Evaluation System for Health Technology (NEST)

Recalls & Alerts

• List of Device Recalls
• Recalls Database
• Safety Communications
• Medical Device Reporting (MDR)

Approvals & Clearances

• 510(k) Clearances
• PMA Approvals

Tools & Resources

• Device Registration and Listing
• Medical Device Databases
• CDRH Ombudsman

Contact FDA

1 (800) 638-2041
(301) 796-7100
DICE@fda.hhs.gov

Information-Medical Devices / Radiation Products
Division of Industry and Consumer Education
CDRH-Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993