Orphan Medical Device

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Office of Orphan Products Development | FDA

https://www.fda.gov/about-fda/office-clinical-policy-and-programs/office-orphan-products-development

[email protected]

Medical products for rare diseases and conditions | FDA

https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions

The Orphan Products Grants program provides funding for clinical trials and natural history studies to help advance rare disease medical product development. The Pediatric …

About Orphan Products Clinical Trial Grants | FDA

https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/about-orphan-products-clinical-trial-grants

Orphan products are drugs, biologics, medical devices, and medical foods that are indicated for a rare disease or condition. Rare diseases, as generally defined in the US …

Orphan devices: yesterday is history; tomorrow is …

https://ojrd.biomedcentral.com/articles/10.1186/s13023-016-0393-3

Orphan devices are medical devices intended for the in-vivo diagnosis, prevention or treatment of a very rare life-threatening or chronically debilitating condition. …

Humanitarian Use Device (HUD) Designation Program

https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/humanitarian-use-device-hud-designation-program

An “orphan subset” is a regulatory phrase used to describe the subset of individuals with a non-rare disease or condition on whom use of a device is appropriate, where use of the …

Orphan Devices for the Surgical Treatment of Patients with Rare ...

https://www.rarediseasesjournal.com/public/articles/orphan-devices-for-the-surgical-treatment-of-patients-with-rare-diseases-present-status-and-recommendations-for-the-future.html

Orphan devices are medical devices intended for the treatment of a very rare life-threatening or chronically debilitating condition. Several institutions (United States Food …

Orphan Products: Hope for People With Rare Diseases

https://www.fda.gov/drugs/information-consumers-and-patients-drugs/orphan-products-hope-people-rare-diseases

An orphan disease is defined as a condition that affects fewer than 200,000 people nationwide. This includes diseases as familiar as cystic fibrosis, Lou Gehrig's disease, …

Orphan medicinal products - Public Health

https://health.ec.europa.eu/medicinal-products/orphan-medicinal-products_en

Orphan medicinal products are intended for the diagnosis, prevention or treatment of life-threatening or very serious conditions that affect no more than 5 in 10,000 people in the …