CFR section
21 CFR 1010.2(c): Certification
PART 1010-PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL · Subpart A-General Provisions
Key facts
| Citation | 21 CFR 1010.2(c) |
|---|---|
| Section | Certification |
| Part | PART 1010-PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL |
| Subpart | Subpart A-General Provisions |
| Subchapter | 21 CFR J Radiological |
| Product types cited | Devices |
| Regulation text (excerpt) | (c) Such certification shall be based upon a test, in accordance with the standard, of the individual article to which it is attached or upon a testing program which is in accordance with good manufacturing practices. The Director, Center for Devices and Radiological Health may disapprove such a testing program on the grounds that it does not assure the adequacy of safeguards against hazardous electronic product radiation or that it does not assure that electronic products comply with the… |
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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.