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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, 2014]
[CITE: 21CFR820.80]
See Related Information on Receiving, in-process, and finished device acceptance. 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 820 -- QUALITY SYSTEM REGULATION

Subpart H--Acceptance Activities

Sec. 820.80 Receiving, in-process, and finished device acceptance.

(a) General. Each manufacturer shall establish and maintain procedures for acceptance activities. Acceptance activities include inspections, tests, or other verification activities.

(b) Receiving acceptance activities. Each manufacturer shall establish and maintain procedures for acceptance of incoming product. Incoming product shall be inspected, tested, or otherwise verified as conforming to specified requirements. Acceptance or rejection shall be documented.

(c) In-process acceptance activities. Each manufacturer shall establish and maintain acceptance procedures, where appropriate, to ensure that specified requirements for in-process product are met. Such procedures shall ensure that in-process product is controlled until the required inspection and tests or other verification activities have been completed, or necessary approvals are received, and are documented.

(d) Final acceptance activities. Each manufacturer shall establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria. Finished devices shall be held in quarantine or otherwise adequately controlled until released. Finished devices shall not be released for distribution until:

(1) The activities required in the DMR are completed;

(2) the associated data and documentation is reviewed;

(3) the release is authorized by the signature of a designated individual(s); and

(4) the authorization is dated.

(e) Acceptance records. Each manufacturer shall document acceptance activities required by this part. These records shall include:

(1) The acceptance activities performed;

(2) the dates acceptance activities are performed;

(3) the results;

(4) the signature of the individual(s) conducting the acceptance activities; and

(5) where appropriate the equipment used. These records shall be part of the DHR.

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