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CFR - CODE OF FEDERAL REGULATIONS TITLE 21

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Help7 | More About 21CFR 8

[Code of Federal Regulations] [Title 21, Volume 8] [CITE: 21CFR820]

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

PART 820QUALITY SYSTEM REGULATION

Subpart O - Statistical Techniques

Sec. 820.250 Statistical techniques.

(a) Where appropriate, each manufacturer shall establish and maintain procedures
for identifying valid statistical techniques required for establishing,
controlling, and verifying the acceptability of process capability and product
characteristics.

(b) Sampling plans, when used, shall be written and based on a valid statistical
rationale. Each manufacturer shall establish and maintain procedures to ensure
that sampling methods are adequate for their intended use and to ensure that
when changes occur the sampling plans are reviewed. These activities shall be
documented.

Authority: 21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h, 360i, 360j, 360l,
371, 374, 381, 383; 42 U.S.C. 216, 262, 263a, 264.
Source: 61 FR 52654, Oct. 7, 1996, unless otherwise noted.

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