§ 814.3 - Definitions.

§ 814.3 Definitions.

For the purposes of this part:

(a) Act means the Federal Food, Drug, and Cosmetic Act (sections 201-902201–902, 52 Stat. 1040 et seq., as amended (21 U.S.C. 321-392–392)).

(b) FDA means the Food and Drug Administration.

(c) IDE means an approved or considered approved investigational device exemption under section 520(g) of the act and parts 812 and 813.

(d) Master file means a reference source that a person submits to FDA. A 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.

(e) PMA means 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 under section 520(1) of the act.

(f) PMA amendment means information an applicant submits to FDA to modify a pending PMA or a pending PMA supplement.

(g) PMA supplement means 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.

(h) Person includes any individual, partnership, corporation, association, scientific or academic establishment, Government agency, or organizational unit thereof, or any other legal entity.

(i) Statement of material fact means 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.

(j) 30-day PMA supplement means a supplemental application to an approved PMA in accordance with § 814.39(e).

(k) Reasonable probability means that it is more likely than not that an event will occur.

(l) Serious, adverse health consequences means 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.

(m) HDE means a premarket approval application submitted pursuant to this subpart seeking a humanitarian device exemption from the effectiveness requirements of sections 514 and 515 of the act as authorized by section 520(m)(2) of the act.

(n) HUD (humanitarian use device) means a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer not more than 48,000 individuals in the United States per year.

(o) Newly acquired information means data, analyses, or other information not previously submitted to the agency, which may include (but are not limited to) data derived from new clinical studies, reports of adverse events, or new analyses of previously submitted data (e.g., meta-analyses) if the studies, events or analyses reveal risks of a different type or greater severity or frequency than previously included in submissions to FDA.

(p) Human cell, tissue, or cellular or tissue-based product (HCT/P) regulated as a device means an HCT/P as defined in § 1271.3(d) of this chapter that does not meet the criteria in § 1271.10(a) and that is also regulated as a device.

(q) Unique device identifier (UDI) means an identifier that adequately identifies a device through its distribution and use by meeting the requirements of § 830.20 of this chapter. A unique device identifier is composed of:

(1) A device identifier - a —a mandatory, fixed portion of a UDI that identifies the specific version or model of a device and the labeler of that device; and

(2) A production identifier - a —a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of the device:

(i) The lot or batch within which a device was manufactured;

(ii) The serial number of a specific device;

(iii) The expiration date of a specific device;

(iv) The date a specific device was manufactured.

(v) For an HCT/P regulated as a device, the distinct identification code required by § 1271.290(c) of this chapter.

(r) Universal product code (UPC) means the product identifier used to identify an item sold at retail in the United States.

(s) Pediatric patients means patients who are 21 years of age or younger (that is, from birth through the twenty-first year of life, up to but not including the twenty-second birthday) at the time of the diagnosis or treatment.

(t) Readily available means available in the public domain through commonly used public resources for conducting biomedical, regulatory, and medical product research.

[51 FR 26364, July 22, 1986, as amended at 61 FR 15190, Apr. 5, 1996; 61 FR 33244, June 26, 1996; 73 FR 49610, Aug. 22, 2008; 78 FR 5582158821, Sept. 24, 2013; 79 FR 1740, Jan. 10, 2014; 82 FR 26349, June 7, 2017]