§1002.40. Records to be obtained by dealers and distributors. — Inbound Citations
21 C.F.R. § 1002.40
Statutory Authority
Cited by 1 regulation in release Current.
Citations to 21 C.F.R. § 1002.40 as a whole
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(a) Information obtained by dealers and distributors pursuant to § 1002.40 shall immediately be forwarded to the appropriate manufacturer unless:(1) The dealer or distributor elects to hold and preserve such information and to immediately furnish it to the manufacturer when advised by the manufacturer or the Director, Center for Devices and Radiological Health, that such information is required for purposes of section 535 of the Act; and(2) The dealer or distributor, upon making the election under paragraph (a)(1) of this section, promptly notifies the manufacturer of such election; such notification shall be in writing and shall identify the dealer or distributor and the electronic product or products for which the information is being accumulated and preserved.