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