Yes, under 21 CFR 803.18(b)(1)(ii) of the eMDR Final Rule, an entity is required to keep paper or electronic copies of all reports submitted to us or to importers, distributors, or manufacturers. In addition, under 21 CFR 803.18(b)(1)(iii) of the eMDR Final Rule, an entity must keep copies of all electronic acknowledgments sent by FDA in response to the entity’s eMDRs.
