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21 CFR Part 820 · Quality Management System Regulation

§ 820.250 Statistical techniques

Subpart O - Statistical Techniques Official text on eCFR Amendment history
Removed from 21 CFR. The Quality Management System Regulation (QMSR) replaced the Quality System Regulation on 2 Feb 2026. Removed by the Quality Management System Regulation, effective 2 February 2026: Part 820 now incorporates ISO 13485:2016 by reference (§ 820.7) and requires it in § 820.10. See § 820.10. The text below is the former QSR wording, kept for reference.

(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. EFFECTIVE DATE NOTE: At 89 FR 7523, Feb. 2, 2024, part 820 was revised, effective Feb. 2, 2026. For the convenience of the user, the revised text is set forth as follows: PART 820—QUALITY MANAGEMENT SYSTEM REGULATION (EFF. 2-2-26) Subpart A—General Provisions Sec. 820.1 Scope. 820.3 Definitions. 820.5 [Reserved] 820.7 Incorporation by reference. 820.10 Requirements for a quality management system. Subpart B—Supplemental Provisions 820.20–820.30 [Reserved] 820.35 Control of records. 820.40 [Reserved] 820.45 Device labeling and packaging controls. Subparts C–O [Reserved] 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. Subpart A—General Provisions

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What FDA inspectors cite under § 820.250

Form FDA 483 observations citing this section, fiscal years 2009–2026 (Devices).

  • Sampling plans 225
  • Statistical techniques - Lack of or inadequate procedures 164
  • Sampling methods - Lack of or inadequate procedures 102
  • Appropriateness 6
  • Review of sampling methods for adequacy 2
  • Invalid technique 2

Warning letters citing § 820.250

12 FDA warning letters since 2017 cite this section :

FDA guidance that cites § 820.250

Amendment history

Federal Register documents that created or amended this section.