I believe my combination product may qualify for designation as an orphan drug or biological product, or as a humanitarian use device. Where can I find information about orphan product regulation?
Information about orphan product and humanitarian use device designation may be found at http://www.fda.gov/orphan/ . If you are unsure whether your product is a drug, biological product, device or combination product (i.e., its regulatory identity is unclear), you are encouraged to submit a Request for Designation (see information above) prior to submitting an orphan product or humanitarian use designation request.
Information about orphan product and humanitarian use device designation may be found on the Developing Products for Rare Diseases & Conditions section of the FDA website. If you are unsure whether your product is a drug, biological product, device or combination product (i.e., its regulatory identity is unclear), you are encouraged to submit a Request for Designation (see information above) prior to submitting an orphan product or humanitarian use designation request.
Related Questions
- I believe my combination product may qualify for designation as an orphan drug or biological product, or as a humanitarian use device. Where can I find information about orphan product regulation?
- Is the product a combination product (i.e., a product comprised ofboth a drug and a device, a device and a biological product, or a drug anda biological product)?
- What studies qualify for orphan product grants?
