Description
During recent factory inspections several manufacturers of microwave ovens expressed concern over the need to retain the results of tests for electronic product radiation safety. Such records, as required by 21 CFR 1002.30(a)(2) must be retained for a period of five years as specified in 21 CFR 1002.31. As a result of the rapidly increasing production rates, the quantity of such test records has resulted in storage problems. The *Center for Devices and Radiological Health* has been requested to provide some relief for this situation. The FDA agrees that the public health or safety will not be adversely affected if guidance is established that would shorten the retention period for some records.
Scope & Applicability
Product Classes
1product listed under 21 CFR 1002.61; compliance survey instruments for microwave ovens; Compliance survey instruments for microwave oven compliance; The subject of the compliance survey instruments being calibrated.; Compliance survey instruments for microwave ovens.
Stakeholders
3Entity responsible for submitting NDINs
Entity holding the lot of product
Entity responsible for submitting NDINs
Regulatory Context
Attributes
1Records must be kept for at least 2 years after Agency decision
Identified Hazards
Hazards
1Radiation emitted by products that must be protected against
Related CFR Sections (3)
- 21CFR1002.41§ 1002.41 Disposition of records obtained by dealers and distributors.
(a) Information obtained by dealers and distributors pursuant to § 1002.40 shall immediately be forwarded to the appropriate manufacturer unless:Read full regulation →
- 21CFR1002.30§ 1002.30 Records to be maintained by manufacturers.
(a) Manufacturers of products listed under table 1 of § 1002.1 shall establish and maintain the following records with respect to such products:Read full regulation →
- 21CFR1002.31§ 1002.31 Preservation and inspection of records.
(a) Every manufacturer required to maintain records pursuant to this part, including records received pursuant to § 1002.41 , shall preserve such records for a period of 5 years from the date of the record.Read full regulation →
See Also (3)
- CPG Sec. 396.200 Exemption for Certain Sunlamp Product Purchaser Records (Status: Final)
- Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (Part 2) (Status: Final)
- Exemption from Reporting and Record keeping Requirements for Certain Sunlamp Product Manufacturers (Status: Final)