§1030.10. Microwave ovens. — Inbound Citations

(iv) Upon application by a manufacturer, the Director, Center for Devices and radiological Health, Food and Drug Administration, may grant an exemption from one or more of the statements (radiation safety warnings) specified in paragraph (c)(6)(i) of this section. Such exemption shall be based upon a determination by the Director that the microwave oven model for which the exemption is sought should continue to comply with paragraphs (c)(1) through (3) of this section under the adverse condition of use addressed by such precautionary statement(s). An application shall be submitted to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Copies of the written portion of the application, including supporting data and information, and the Director's action on the application will be maintained by the Dockets Management Branch for public review. The application shall include:

(a) The specific microwave oven model(s) for which the exemption is sought.

(b) The specific radiation safety warning(s) from which exemption is sought.

(c) Data and information which clearly establish that one or more of the radiation safety warnings in paragraph (c)(6)(i) of this section is not necessary for the specified microwave oven model(s).

(d) Such other information and a sample of the applicable product if required by regulation or by the Director, Center for Devices and Radiological Health, to evaluate and act on the application.

(iv) Upon application by a manufacturer, the Director, Center for Devices and radiological Health, Food and Drug Administration, may grant an exemption from one or more of the statements (radiation safety warnings) specified in paragraph (c)(6)(i) of this section. Such exemption shall be based upon a determination by the Director that the microwave oven model for which the exemption is sought should continue to comply with paragraphs (c)(1) through (3) of this section under the adverse condition of use addressed by such precautionary statement(s). An application shall be submitted to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Copies of the written portion of the application, including supporting data and information, and the Director's action on the application will be maintained by the Dockets Management Branch for public review. The application shall include:

(a) The specific microwave oven model(s) for which the exemption is sought.

(b) The specific radiation safety warning(s) from which exemption is sought.

(c) Data and information which clearly establish that one or more of the radiation safety warnings in paragraph (c)(6)(i) of this section is not necessary for the specified microwave oven model(s).

(d) Such other information and a sample of the applicable product if required by regulation or by the Director, Center for Devices and Radiological Health, to evaluate and act on the application.

(iv) Upon application by a manufacturer, the Director, Center for Devices and radiological Health, Food and Drug Administration, may grant an exemption from one or more of the statements (radiation safety warnings) specified in paragraph (c)(6)(i) of this section. Such exemption shall be based upon a determination by the Director that the microwave oven model for which the exemption is sought should continue to comply with paragraphs (c)(1) through (3) of this section under the adverse condition of use addressed by such precautionary statement(s). An application shall be submitted to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Copies of the written portion of the application, including supporting data and information, and the Director's action on the application will be maintained by the Dockets Management Branch for public review. The application shall include:

(a) The specific microwave oven model(s) for which the exemption is sought.

(b) The specific radiation safety warning(s) from which exemption is sought.

(c) Data and information which clearly establish that one or more of the radiation safety warnings in paragraph (c)(6)(i) of this section is not necessary for the specified microwave oven model(s).

(d) Such other information and a sample of the applicable product if required by regulation or by the Director, Center for Devices and Radiological Health, to evaluate and act on the application.