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QS & the FDA: DSMICA

The Division of Small Manufacturers, International and Consumer Assistance (DSMICA) provides technical and regulatory assistance to small manufacturers to help them comply with Food and Drug Administration (FDA) requirements for medical devices.

  • Please include your email address, telephone and fax numbers if you desire a response.

    CDRH/OCER/DSMICA (HFZ-220)
    1350 Piccard Drive
    Rockville, MD 20850-4307

    Email: dsmica@cdrh.fda.gov
    Telephone Numbers: 301-796-7100 or 800-638-2041
    Fax Number: 240-276-3151

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