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 A–General Provisions § 820.1 – Scope. § 820.3 – Definitions. § 820.5 – Quality system. Subpart B–Quality System Requirements § 820.20 – Management responsibility. § 820.22 – Quality audit. § 820.25 – Personnel. Subpart C–Design Controls § 820.30 – Design controls. Subpart D–Document Controls § 820.40 – Document controls. Subpart E–Purchasing Controls § 820.50 – Purchasing controls. Subpart F–Identification and Traceability § 820.60 – Identification. § 820.65 – Traceability. Subpart G–Production and Process Controls § 820.70 – Production and process controls. § 820.72 – Inspection, measuring, and test equipment. § 820.75 – 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 – Corrective and preventive action. Subpart K–Labeling and Packaging Control § 820.120 – Device labeling. § 820.130 – Device packaging. Subpart L–Handling, Storage, Distribution, and Installation § 820.140 – Handling. § 820.150 – Storage. § 820.160 – Distribution. § 820.170 – Installation. Subpart M–Records § 820.180 – General requirements. § 820.181 – Device master record. § 820.184 – Device history record. § 820.186 – Quality system record. § 820.198 – Complaint files. Subpart N–Servicing § 820.200 – Servicing. Subpart O–Statistical Techniques § 820.250 – Statistical techniques.
