2011-31867. Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian Use Device Designations; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and FDA staff entitled “Humanitarian Use Device (HUD) Designations.” Devices are eligible for HUD designation if they are designed to treat or diagnose a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year. Devices that receive HUD designation may be eligible for marketing approval under the Humanitarian Device Exemption (HDE) marketing pathway. This guidance document is intended to assist applicants in the preparation and submission of HUD designation requests and FDA reviewers in evaluating such requests.

DATES:

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by March 12, 2012.

ADDRESSES:

Submit written requests for single copies of the draft guidance to the Office of Orphan Products Development (OOPD), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 5271, Silver Spring, MD 20993. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Eric Chen, Office of Orphan Products Development, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5271, Silver Spring, MD 20993, [phone].

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft guidance for industry and FDA staff entitled “Humanitarian Use Device (HUD) Designations.” Devices are eligible for HUD designation if they are designed to treat or diagnose a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year. (See section 520(m) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360j(m)); 21 CFR 814.102). This guidance document is intended to assist applicants in the preparation and submission of HUD designation requests to FDA, OOPD. This guidance is also intended to assist FDA reviewers in the evaluation and analysis of HUD designation requests.

Topics addressed in this guidance include: (1) Demonstrating in HUD requests that the device is designed to treat or diagnose a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year; (2) how this demonstration varies, depending on whether the device is intended for therapeutic or diagnostic purposes; (3) how properties of the device may affect this demonstration; and (4) delineating a medically plausible subset of persons with a given disease or condition.

Devices that receive HUD designation may be eligible for marketing approval under an HDE application. An HDE application is a premarketing application that is similar to a premarket approval (PMA) application in that the applicant must demonstrate a reasonable assurance of safety, but in an HDE application, the applicant seeks an exemption from the PMA requirement to demonstrate a reasonable assurance of effectiveness. A device is eligible for HDE approval if, among other criteria, the probable benefit to health from use of the device outweighs the risk of injury or illness from its use, taking into account the probable risks and benefits of currently available devices or alternative forms of treatment. (See section 520(m) of the FD&C Act; 21 CFR 814.104(b)(2)). Although a HUD designation is a prerequisite to submitting an HDE application, it is only one of many required elements of the application (21 CFR 814.104). Receipt of a HUD designation does not guarantee that the HDE marketing application will be approved.

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency's current thinking on humanitarian use device designations. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 814, subpart H, have been approved under OMB control number 0910-0332.

III. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

Persons with access to the Internet may obtain the document at either http://www.fda.gov/​RegulatoryInformation/​Guidances/​default.htm or http://www.regulations.gov.

Dated: December 7, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.