§ 804.33 - Alternative reporting requirements.

(a) Distributors may request exemptions from any or all of the reporting requirements in this part. These requests are required to be in writing and to include both the information necessary to identify the firm and device and an explanation why the request is justified.

(b) FDA may grant a distributor, in writing, an exemption from any or all of the reporting requirements in this part and may change the frequency of reporting to quarterly, semiannually, annually, or other appropriate time periods. In granting such exemptions, FDA may impose other reporting requirements to ensure the protection of public health and safety. FDA may also authorize the use of alternative reporting media such as magnetic tape or disk, in lieu of FDA forms.

(c) FDA may revoke alternative reporting options, in writing, if FDA determines that protection of the public health justifies a return to the requirements as stated in this part.