CFR section
21 CFR 1010.3(a)(2): Identification
PART 1010-PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL · Subpart A-General Provisions
Key facts
| Citation | 21 CFR 1010.3(a)(2) |
|---|---|
| Section | Identification |
| 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) | (2) The place and month and year of manufacture: (i) The place of manufacture may be expressed in code provided the manufacturer has previously supplied the Director, Center for Devices and Radiological Health with the key to such code. (ii) The month and year of manufacture shall be provided clearly and legibly, without abbreviation, and with the year shown as a four-digit number as follows in this paragraph. Alternatively, a manufacturer may utilize a manufacturing symbol and date format that… |
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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.