I was wrong

[norcalmom]

Resourses to help all of us..

 

But the big error was - that RARE disease resources start at less than 4000 in the US per year...not 200 (got that from some other defination of "rare"). so maybe someone in this program can help us...

 

"The Humanitarian Use Device (HUD) program designates a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects fewer than 4,000 individuals in the United States per year as per 21 CFR 814.3(n). "

Designating Humanitarian Use Devices (HUDS)

The Humanitarian Use Device or HUD program was established in 1990 with passage of the Safe Medical Devices Act and creates an alternative pathway for getting market approval for medical devices that may help people with rare diseases or conditions. As defined by 21 CFR 814.3(n), a HUD is a “medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year.” In order to obtain HUD designation, the applicant must provide authoritative references to demonstrate that the device meets the definition of 21 CFR 814.3(n). In addition to the documentation describing the disease or condition, the applicant must also provide the proposed indications for use of the device, and the reasons why such a device is needed for the patient population. One aspect that has becoming increasingly difficult is if the HUD is proposed for an indication that represents a subset of a common disease or condition. In these situations, the applicant must demonstrate that the subset is a medically plausible patient population. A medically plausible subset is considered a regulatory concept where an aspect of the HUD precludes its use in the entire disease or condition. A medically plausible subset is not a readily identifiable subset or a group of patients who meet or do not meet the inclusion and exclusion criteria for a clinical study. Likewise, they are not patients with an unmet medical need. If the HUD application is designated, the applicant can then submit the HDE marketing application to the Center for Devices and Radiological Health (CDRH) for marketing review.

[norcalmom]

So I'm thinking who would apply for something like this - and my thought is IVIG manufacturers...like Talecris Biotherapeutics, Inc. - the manufacturers of Gamunex.