10699. DEFINITIONS

10699 DEFINITIONS 10699.1 As used in this chapter, the following terms shall have the meanings ascribed: Act – the Federal Food, Drug, and Cosmetic Act, approved June 25, 1938, (31 U.S.C. § 301, et seq.) Humanitarian Device Exemption (HDE) – an application that is similar to a premarket approval (PMA) application, but is exempt from the effectiveness requirements of 21 U.S.C. §§ 360d and 360e of the Food, Drug, and Cosmetic Act. Humanitarian Use Device (HUD) –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 four thousand (4,000) individuals in the U. S. per year. Investigational Device – a device, including a transitional device, that is the object of an investigation. Investigational Device Exemption (IDE) – a process whereby an investigational device is allowed to be used in a clinical study in order to collect safety and effectiveness data required to support a premarket approval (PMA) application or a premarket notification (21 U.S.C. § 360(k)) submission to FDA. Master File – a reference source that a person submits to the Department of Health master file may contain detailed information on a specific manufacturing facility, process, methodology, or component used in the manufacture, processing, or packaging of a medical device. Person – any individual, partnership, corporation, association, scientific or academic establishment, Government agency, or organizational unit thereof, or any other legal entity. PMA – any premarket approval application for a class III medical device, including all information submitted with or incorporated by reference therein. ``PMA'' includes a new drug application for a device. PMA amendment – information an applicant submits to the Department of Health to modify a pending PMA or a pending PMA supplement. PMA supplement – a supplemental application to an approved PMA for approval of a change or modification in a class III medical device, including all information submitted with or incorporated by reference therein. Reasonable probability – it is more likely than not that an event will occur. Statement of material fact – a representation that tends to show that the safety or effectiveness of a device is more probable than it would be in the absence of such a representation. A false affirmation or silence or an omission that would lead a reasonable person to draw a particular conclusion as to the safety or effectiveness of a device also may be a false statement of material fact, even if the statement was not intended by the person making it to be misleading or to have any probative effect. Serious, adverse health consequences – any significant adverse experience, including those which may be either life-threatening or involve permanent or long term injuries, but excluding injuries that are nonlife-threatening and that are temporary and reasonably reversible. Thirty (30) - day PMA supplement – a supplemental application to an approved PMA in accordance with § 10608. Transitional device – a device subject to 21 U.S.C. § 360j(1) of the act, that is, a device that the FDA considered to be a new drug or an antibiotic drug before May 28, 1976. SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10699