Source: http://www.emergogroup.com/resources/regulations-united-states/21-cfr-820
Timestamp: 2016-05-29 13:22:46
Document Index: 677889422

Matched Legal Cases: ['art 820', 'art 820', 'art 820', 'art 820', 'art 820', 'art 820', '§ 820', '§ 820', '§ 820', '§ 820', '§ 820', '§ 820', '§ 820', '§ 820', '§ 820', '§ 820', '§ 820', '§ 820', '§ 820', '§ 820', '§ 820', '§ 820', '§ 820', '§ 820', '§ 820', '§ 820', '§ 820', '§ 820', '§ 820', '§ 820', '§ 820', '§ 820', '§ 820', '§ 820', '§ 820', 'art 80704', 'art 80104', 'art 80304', 'art 82104', 'art 80604', 'art 82004']

US FDA Quality System Regulation (QSR) – 21 CFR Part 820
US FDA (21 CFR Part 820): Quality System Regulation (QSR)
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[Code of Federal Regulations][Title 21, Volume 8][Revised as of April 1, 2014][CITE: 21CFR820]
Title 21 - Food and DrugsChapter I - Food and Drug AdministrationDepartment of Health and Human Services (HHS)Subchapter H - Medical DevicesPart 820 QUALITY SYSTEM REGULATION (QSR)
Subpart A--General Provisions § 820.1
§ 820.3
§ 820.5
- Quality System.
Subpart B--Quality System Requirements § 820.20
- Management responsibility.
§ 820.22
- Quality Audit.
§ 820.25
Subpart C--Design Controls § 820.30
- Design Controls.
Subpart D--Document controls § 820.40
- Document Controls.
§ 820.50
- Purchasing Controls.
§ 820.60
§ 820.65
Subpart G--Production and Process Controls § 820.70
- Production and process controls.
§ 820.72
- Inspection, measuring, and test equipment.
- Process validation.
Subpart H--Acceptance Activities § 820.80
- Receiving, in-process, and finished device acceptance.
§ 820.86
- Acceptance status.
Subpart I--Nonconforming Product § 820.90
- Nonconforming product.
Subpart J--Corrective and Preventive Action § 820.100
§ 820.120
- Device labeling.
§ 820.130
Subpart L--Handling, Storage, Distribution, and Installation § 820.140
§ 820.150
§ 820.160
§ 820.170
Subpart M--Records § 820.180
§ 820.181
- Device master record.
§ 820.184
- Device history record.
§ 820.186
- Quality system record.
§ 820.198
- Complaint files.
Subpart O--Statistical Techniques § 820.250
(e) Exemptions or variances . (1) Any person who wishes to petition for an exemption or variance from any device quality system requirement is subject to the requirements of section 520(f)(2) of the act. Petitions for an exemption or variance shall be submitted according to the procedures set forth in 10.30 of this chapter, the FDA's administrative procedures. Guidance is available from the Food and Drug Administration, Center for Devices and Radiological Health, Division of Small Manufacturers, International and Consumer Assistance, 10903 New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993-0002, 1-800-638-2041 or 301-796-7100, FAX: 301-847-8149.
[61 FR 52654, Oct. 7, 1996, as amended at 65 FR 17136, Mar. 31, 2000; 65 FR 66636, Nov. 7, 2000; 69 FR 29829, May 25, 2005; 72 FR 17399, Apr. 9, 2007; 75 FR 20915, Apr. 22, 2010]
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.
DocumentLanguageNumberPublished Establishment Registration & Device Listing For Manufacturers & Importers Of Devices en 21 CFR Part 80704/2010 Food, Drug and Cosmetic Act - Medical Devicesen Chap 509/2014 Labeling en 21 CFR Part 80104/2012 Medical Device Reportingen 21 CFR Part 80304/2010 Medical Device Tracking Requirements en 21 CFR Part 82104/2011 Medical Devices; Reports Of Corrections And Removalsen 21 CFR Part 80604/2010 Quality Systems Regulations (QSR) en 21 CFR Part 82004/2014 General Guidance Documents