CFR section
21 CFR 820.30(a): Design controls
PART 820-QUALITY SYSTEM REGULATION · Subpart C-Design Controls
Key facts
| Citation | 21 CFR 820.30(a) |
|---|---|
| Section | Design controls |
| Part | PART 820-QUALITY SYSTEM REGULATION |
| Subpart | Subpart C-Design Controls |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices, Drugs, Food/Cosmetics, General, Other_Regulations |
| Regulation text (excerpt) | (a) General. (1) Each manufacturer of any class III or class II device, and the class I devices listed in paragraph (a)(2) of this section, shall establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met. (2) The following class I devices are subject to design controls: (i) Devices automated with computer software; and (ii) The devices listed in the following chart. Section Device 868.6810 Catheter, Tracheobronchial… |
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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.