10618.1 The purpose of this section is, to the extent consistent with the protection of the public health and safety and with ethical standards, to encourage the discovery and use of devices intended to benefit patients in the treatment or diagnosis of diseases or conditions that affect or are manifested in fewer than four thousand (4,000) individuals in the United States per year. This section provides procedures for obtaining:

(a) Humanitarian use device (HUD) designation of a medical device; and

(b) Marketing approval for the HUD notwithstanding the absence of reasonable assurance of effectiveness that would otherwise be required.

10618.2 Although a HUD may also have uses that differ from the humanitarian use, applicants seeking approval of any non-HUD use shall submit a PMA as required in § 10606 or a premarket notification as required in Chapter 105.

10618.3 Obtaining marketing approval for a HUD involves two (2) steps:

(a) Obtaining designation of the device as a HUD from DOH, and

(b) Submitting a humanitarian device exemption (HDE) to the Department.

10618.4 A person granted an exemption shall submit periodic reports as described in § 10632.1.

10618.5 The Department may suspend or withdraw approval of an HDE after providing notice and an opportunity for an informal hearing.

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013).