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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H - MEDICAL DEVICES
 
PART 810MEDICAL DEVICE RECALL AUTHORITY
 

Subpart A - General Provisions
   § 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 - Cease distribution and notification order.
   § 810.11 - Regulatory hearing.
   § 810.12 - Written request for review of cease distribution and notification order.
   § 810.13 - Mandatory recall order.
   § 810.14 - Cease distribution and notification or mandatory recall strategy.
   § 810.15 - Communications concerning a cease distribution and notification or mandatory recall order.
   § 810.16 - Cease distribution and notification or mandatory recall order status reports.
   § 810.17 - Termination of a cease distribution and notification or mandatory recall order.
   § 810.18 - Public notice.

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 otherwise noted.

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