§4.105. What are the postmarketing safety reporting recordkeeping requirements for your combination product or constituent part? — Inbound Citations

(c) For combination products containing a device constituent part, Importers must submit the reports to the manufacturer and to FDA described in § 4.102(c)(1) of this chapter and maintain the records described in §§ 4.102(c)(1) and 4.105(b) of this chapter.