Title 21: Food and Drugs
PART 810—MEDICAL DEVICE RECALL AUTHORITY
Contents
Subpart A—General Provisions
石家庄43中§810.1 Scope. §810.2 Definitions. §810.3 Computation of time. §810.4 Service of orders.
Subpart B—Mandatory Medical Device Recall Procedures
§810.10 Cea distribution and notification order. §810.11 Regulatory hearing. §810.12 Written request for review of cea distribution and notification order. §810.13 Mandatory recall order. §810.14 Cea distribution and notification or mandatory recall strategy. §810.15 Communications concerning a cea distribution and notification or mandatory recall order. §810.16 Cea distribution and notification or mandatory recall order status reports. §810.17 Termination of a cea distribution and notification or mandatory recall order. §810.18 Public notice.
2012年高考语文作文题目AUTHORITY: 21 U.S.C. 321, 331, 332, 333, 334, 351, 352, 355, 360h, 360i, 371, 374, 375.
SOURCE: 61 FR 59018, Nov. 20, 1996, unless otherwi noted.
Subpart A—General Provisions
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§810.1 Scope.
Part 810 describes the procedures that the Food and Drug Administration will follow in exercising its medical device recall authority under ction 518(e) of the Federal Food, Drug, and Cosmetic Act. 生态环境 英语
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§810.2 Definitions.
As ud in this part:
(a) Act means the Federal Food, Drug, and Cosmetic Act.
(b) Agency or FDA means the Food and Drug Administration.
(c) Cea distribution and notification strategy or mandatory recall strategy 副词修饰什么befamousformeans a planned, specific cour of action to be taken by the person named in a cea distribution and notification order or in a mandatory recall order, which address 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, purchad, or ud a device that is subject to a cea 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 u to some other location.
(f) Device ur 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, nurs, 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 u.
fiend(h) Human cell, tissue, or cellular or tissue-bad 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.
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(j) 4366Serious, adver health conquence means any significant adver experience, including tho 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 u where FDA finds that there is a reasonable probability that the device would cau rious, adver health conquences or death.
(l) Removal means the physical removal of a device from its point of u 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 u by meeting the requirements of §830.20 of this chapter. A unique device identifier is compod 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
托福词汇表(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 rial number of a specific device; 我心永恒英文歌词
