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IND/IDE Contact Information

Questions about medical devices (other than gcp questions)

• www.fda.gov/cdrh/dsma/dsmastaf.html
• Manufacturer's assistance: 800-638-2041
• Consumer assistance: 888-INFO-FDA
• Questions about whether a product is subject to IDE regulations: call 240-276-4040

Questions about drug products (other than gcp questions)

• 301-827-4570
• Druginfo@fda.hhs.gov
• Questions about whether a product is subject to IND regulations: call 301-827-4570

Questions about biologics (other than gcp questions)

• 301-827-2000
• Octma@cber.fda.gov (consumer oriented)
• Matt@cber.fda.gov (manufacturers's assistance)
• Questions about whether a product is subject to IND regulations: call 301-827-2000

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