FDA Contacts for Other Program Areas
MedWatch: To report problems including serious
adverse reactions, product quality problems, and medical errors suspected to
be associated with drugs, medical devices, biologics (except vaccines), medical
foods and dietary supplements prescribed, dispensed, or used:
VAERS (Vaccine Adverse Event Report System):
To report problems with vaccines ( for human use)
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 301-594-1190
Questions about drug products (other than gcp questions)
- 301-827-3454
- Druginfo@cder.fda.gov
- Questions about whether a product is subject to IND regulations: call 301-827-3454
Questions about biologics (other than gcp questions)
- 301-827-0373
- Octma@cber.fda.gov (consumer oriented)
- Matt@cber.fda.gov (manufacturers's
assistance)
- Questions about whether a product is subject to IND regulations: call 301-827-0373
