Get the Latest Regulatory Educational Materials from CDRH

The Division of Industry and Consumer Education (DICE) at the FDA’s Center for Devices and Radiological Health (CDRH) has developed the resources below to provide you with the most current and accurate information about medical devices and radiation-emitting products.

Device Advice

CDRH recently posted these program updates in Device Advice:

• Medical Device Databases (09/16/2021)
• 510(k) Program Pilots (09/28/2021)
• Device Registration and Listing (10/01/2021)
• De Novo Classification Request (10/04/2021)

CDRH Learn

CDRH recently posted the following educational module:

Postmarket Activities section (under “Inspections – Global Harmonization”)

• (10) MDSAP: Purchasing Process

CDRH also released the following educational modules on the Spanish section of CDRH Learn:

Cómo comercializar su dispositivo – How to Market Your Device

• ¿Cómo se clasifica mi dispositivo médico? - How is My Medical Device Classified? (09/10/2021)

Actividades de postventa – Postmarket Activities

• Importación de Dispositivos Médicos a los Estados Unidos – Importing Medical Devices Into the United States (09/02/2021)

View CDRH Learn List of Modules

Watch Regulatory Education for Industry (REdI) 2021 Annual Conference!

If you missed the live broadcast of the REdI 2021 Annual Conference, view the recordings:

• Plenary Session: Leading FDA’s Emergency Response to the COVID-19 Pandemic (07/19/2021)
• Devices Track (07/20/2021)
• Devices Track (continued) (07/21/2021)

Seasonal Reminders: Fiscal Year 2022 User Fees Now In Effect; Register and List Now

• User Fees: Please note the Fiscal Year 2022 medical device user fees are in effect from October 01, 2021 through September 30, 2022, listed here.
• Registration and Listing:
  • Annual registration - must be submitted each year between October 1 and December 31, even if no changes have occurred.
  • Listing must be reviewed each year between October 1 and December 31, at the same time you review your registration information. Submit any updates at that time.

New ASCA Accreditation

The Accreditation Scheme for Conformity Assessment (ASCA) Pilot has granted ASCA Accreditation to 77 testing laboratories (as of 10/04/2021), who are qualified to conduct testing under this voluntary program.

The FDA invites device sponsors, accreditation bodies, and testing laboratories to watch the Industry Basics program to learn more about how standards use and the ASCA program may benefit device review. For program details, please consult the ASCA Web page.