§ 810.2 Definitions. As used in this part: ( a ) *Act* means the Federal Food, Drug, and Cosmetic Act.
( b ) Agency or FDA means the Food and Drug Administration.
( c ) Cease distribution and notification strategy or mandatory recall strategy means a planned, specific course of action to be taken by the person named in a cease distribution and notification order or in a mandatory recall order, which addresses the extent of the notification or recall, the need for public warnings, and the extent of effectiveness checks to be conducted.
( d ) *Consignee* means any person or firm that has received, purchased, or used a device that is subject to a cease distribution and notification order or a mandatory recall order. Consignee does not mean lay individuals or patients, i.e., nonhealth professionals.
( e ) *Correction* means repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a device, without its physical removal from its point of use to some other location.
( f ) *Device user facility* means a hospital, ambulatory surgical facility, nursing home, or outpatient treatment or diagnostic facility that is not a physician's office.
( g ) *Health professionals* means practitioners, including physicians, nurses, pharmacists, dentists, respiratory therapists, physical therapists, technologists, or any other practitioners or allied health professionals that have a role in using a device for human use.
( h ) *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.
( i ) *Reasonable probability* means that it is more likely than not that an event will occur.
( j ) *Serious, adverse health consequence* means any significant adverse experience, including those that 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.
( k ) *Recall* means the correction or removal of a device for human use where FDA finds that there is a reasonable probability that the device would cause serious, adverse health consequences or death.
( l ) *Removal* means the physical removal of a device from its point of use to some other location for repair, modification, adjustment, relabeling, destruction, or inspection.
( m ) *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 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 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.
[61 FR 59018, Nov. 20, 1996, as amended at 78 FR 58821, Sept. 24, 2013]