Device Advice: Comprehensive Regulatory Assistance

 

Welcome to Device Advice, the Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) web page for comprehensive regulatory education. Device Advice is CDRH's premier text-based resource that explains medical device laws, regulations, guidances, and policies, across the entire product lifecycle.

Bringing a Device to Market

Is it a Medical Device?

Medical Device User Fees

How to Study and Market Your Device

Device Registration and Listing

Search Medical Device Databases

All Medical Device Databases

Find FDA Guidance Documents

Find Medical Device Forms

Code of Federal Regulations (CFR)

Resources

CDRH Learn

CDRH Learn is our multi-media educational resource, featuring learning modules that address medical device laws, regulations, guidances, and policies, across the entire product life cycle.

CDRH Webinars

CDRH Webinars feature FDA presentations and live stakeholder question and answer discussions about timely medical device laws, regulations, guidances, or programs.

Contact Us

Division of Industry and Consumer Education
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993

DICE@fda.hhs.gov

(800) 638-2041

(301) 796-7100

Office of Communication and Education