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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2013]
[CITE: 21CFR810.2]
See Related Information on Definitions. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES

PART 810 -- MEDICAL DEVICE RECALL AUTHORITY

Subpart A--General Provisions

Sec. 810.2 Definitions.

As used in this part:

(a)Act means the Federal Food, Drug, and Cosmetic Act.

(b)Agency orFDA means the Food and Drug Administration.

(c)Cease distribution and notification strategy ormandatory 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)Reasonable probability means that it is more likely than not that an event will occur.

(i)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.

(j)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.

(k)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.

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