Medical Devices

Device Advice: Comprehensive Regulatory Assistance

FDA Lapse in Funding

In the absence of either an FY 2019 appropriation or a Continuing Resolution for FDA, beginning on December 22, 2018 and continuing until the date of enactment of an FY 2019 appropriation or Continuing Resolution ("lapse period"), agency operations continue to the extent permitted by law, such as activities necessary to address imminent threats to the safety of human life and activities funded by carryover user fee funds. Read more

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, covering both premarket and postmarket topics.

Device Advice is intended to provide industry with information that is accurate, timely, comprehensive, and useful.

Additional Information

Approvals & Clearances

Contact Us

Toll-free: 1-800-638-2041
Phone: 301-796-7100

Division of Industry and Consumer Education (DICE)
Office of Communication and Education
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993

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Page Last Updated: 12/26/2018
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