§ 4.104. How and where must you submit postmarketing safety reports for your combination product or constituent part?
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/us/cfr/t21/s§ 4.104·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)If you are a constituent part applicant, you must submit postmarketing safety reports in accordance with the regulations identified in § 4.102(b) that are applicable to your product based on its application type.
(b)If you are a combination product applicant, you must submit postmarketing safety reports required under § 4.102 in the manner specified in the regulation applicable to the type of report, with the following exceptions:
(1)You must submit the postmarketing safety reports identified in § 4.102(c)(1)(i) and
(ii)in accordance with § 314.80(g) of this chapter if your combination product received marketing authorization under an NDA or ANDA or in accordance with § 600.80(h) of this chapter if your combination product received marketing authorization under a BLA.
(2)You must submit the postmarketing safety reports identified in § 4.102(c)(2)(ii) and (c)(3)(ii) in accordance with § 803.12(a) of this chapter if your combination product received marketing authorization under a device application.
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§ 4.104
How and where must you submit postmarketing safety reports for your combination product or constituent part?
Fed. Reg.×4
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