CFR section
21 CFR 1010.4(d): Variances
PART 1010-PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL · Subpart A-General Provisions
Key facts
| Citation | 21 CFR 1010.4(d) |
|---|---|
| Section | Variances |
| 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) | (d) Certification of equipment covered by variance. The manufacturer of any product for which a variance is granted shall modify the tag, label, or other certification required by § 1010.2 to state: (1) That the product is in conformity with the applicable standard, except with respect to those characteristics covered by the variance; (2) That the product is in conformity with the provisions of the variance; and (3) The assigned number and effective date of the variance. |
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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.