CFR section
21 CFR 1010.2(a): Certification
PART 1010-PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL · Subpart A-General Provisions
Key facts
| Citation | 21 CFR 1010.2(a) |
|---|---|
| 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) | (a) Every manufacturer of an electronic product for which an applicable standard is in effect under this subchapter shall furnish to the dealer or distributor, at the time of delivery of such product, the certification that such product conforms to all applicable standards under this subchapter. |
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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.