US FDA Humanitarian Use Device(HUD)/Humanitarian Device Exemption(HDE)

 To market a medical device in US, manufacturer shall provide a reasonable assurance that the device is safe and effective.

Under HUD/HDE allow the manufacturer to show their device is safe and provides a probable benefit

HUD: 21 CFR 814.3(n)

A Humanitarian Use Device (HUD) is a medical device intended to benefit patients in treatment or diagnosis of a disease or condition that affects or is manifested in not more than 8,000 individuals per year in the United States.

 Manufacturer shall get a HUD designation request and receive approval from the FDA’s Office of Orphan Products Development.

After HUD designation is granted, submit an HDE application to the Center for Devices and Radiological Health (CDRH) or Center for Biologics Evaluation and Research (CBER).

 HUD Designation:

Sponsor submits a HUD Designation Request to FDA’s Office of Orphan Products Development (OOPD). FDA will send an acknowledgement letter with an assigned HUD number for each application.

FDA will provide decision within 45 days to the applicant

• Approval
• Disapproval
• Request Additional Information

Content of HUD Request

• Cover Letter
• Description of the Disease or Condition
• Population Estimate
• Description of the Device and Scientific Rationale for its Proposed Use
• Supporting Documentation with Appended References

Content of HDE Request

• Copy of/reference to HUD designation letter
• Explanation of why device not otherwise available
• Statement that no comparable device is legally marketed (approved or cleared)
• Device description
• Indications for Use
• Valid Scientific Evidence
• Explanation of why probable benefit outweighs risk
• Manufacturing Information
• Amount being charged
• Request for Profit(if requesting exception to profit prohibition)
• Labeling

Documents issued by FDA for Product HDE Approval

Once FDA approve the HDE, Manufacturer will receive the following documents,

The following are posted on the FDA’s public PMA database:

• Approval Order
• Summary of Safety and Probable Benefit (SSPB)
• Labeling
• Consumer Information (short summary of the device and its intended use)

·     FDA Review –

1. Sponor shall get the HUD designation first.Sponsor submits the ecopy to FDA CDRH's or CBER’s Document Control Center (DCC). FDA will send the acknowledgement letter.

2.FDA Filing Review: administrative and limited scientific review (21 CFR 814.112)

Within30 calendar days FDA will notify below to manufacturer: Decision: Filled or Not Filled

3. Substantive Review 21 CFR 814.116:Lead reviewer will assess the application( In-depth scientific, regulatory, and quality systems review) and share the below information to manufacturer.

• Interactive review
• Issue Major Deficiency Letter.HDE request will be placed on hold.
• Advisory Panel Meeting. Public meeting to review the HDE 

Decision:

Approval Order: Device may be marketed. Identifies conditions of approval. FDA provides the Annual Distribution Number (ADN), if the FDA determines that the HDE holder is eligible to sell the device for profit.

Approvable Letter: Minor deficiencies that must be resolved in order for the application to be approved.

Major Deficiency Letter: Major deficiencies that must be resolved in order for the application to be approved. It doesn’t require new clinical and/or substantive nonclinical evidence.

Not Approvable Letter: Significant deficiencies that must be resolved in order for the application to be approved. It requires new clinical and/or substantive nonclinical evidence.

 References:

HDE : https://www.fda.gov/medical-devices/humanitarian-device-exemption/getting-humanitarian-use-device-market#review

HDE database: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfHDE/hde.cfm

 HDE Guidance: www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM336515.pdf