Medical Devices:

Links to U.S. Laws and Regulations

Pre-Market Approval (PMA):

21 CFR Sub. Ch. H, Pt. 814, Sub. Pt. B, §§ 814.20-814.39

Pre-Market Notification (PMN):

21 USC § 360(k)

21 CFR Sub. Ch. H, Pt. 807, Sub. Pt. E, §§ 807.81-807.100

Investigational Device Exemption (IDA):

21 USC § 360j(g)

21 CFR Sub. Ch. H, Pt. 812, Sub. Pt. B, §§ 812.20-812.38

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