Device Advice: Comprehensive Regulatory Assistance
CDRH Operating Status During COVID-19
- CDRH Document Control Center (DCC): Open. Will continue to process submissions. DCC Contact Information and Address.
- CDRH Reviews: Ongoing.
- Marketing Submissions Currently On Hold: See Question/Answer of FDA Guidance on "Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices"
Regulatory Education for Industry (REdI) Annual Conference
June 6-10 – Register for this conference on topics including 510(k)s, inspections, and regulatory responsibilities.
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 many aspects of medical device laws, regulations, guidances, and policies, encompassing the entire product life cycle.
Resources
Webinar
CDRH hosts webinars and calls to educate stakeholders on guidances and other topics related to the regulation of medical devices and radiation-emitting products. This web page contains information about such events, both past and upcoming.
CDRH Learn
CDRH Learn is our innovative educational tool, which consists of learning modules describing many aspects of medical device and radiation emitting product regulations, covering both premarket and postmarket topics.
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Contact Us
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993