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).