CFR section
21 CFR 820.20(d): Management responsibility
PART 820-QUALITY SYSTEM REGULATION · Subpart B-Quality System Requirements
Key facts
| Citation | 21 CFR 820.20(d) |
|---|---|
| Section | Management responsibility |
| Part | PART 820-QUALITY SYSTEM REGULATION |
| Subpart | Subpart B-Quality System Requirements |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices, Drugs, General, Other_Regulations |
| Regulation text (excerpt) | (d) Quality planning. Each manufacturer shall establish a quality plan which defines the quality practices, resources, and activities relevant to devices that are designed and manufactured. The manufacturer shall establish how the requirements for quality will be met. |
At a glance
- 100–999 Inspections citing this section
- 10–99 Warning letters citing this section
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About CFR sections cited by the FDA
Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.