| | Preamble: 21 CFR Parts 20 and 814 |
 | | Upon further consideration, the agency agrees that placing the HDE provisions in the IDE regulations is inappropriate because section 520(m) of the act is intended to facilitate the discovery and use of HUD's rather than to promote their use in clinical studies. |
| | Although the final rule for HDE's provides for marketing approval under subpart H of part 814, rather than investigation under part 812, this comment does raise the issue of whether the HDE application, which is a marketing application under part 814, must contain "valid scientific evidence" as defined in § 860.7. |
| | In order to implement this exemption, FDA is amending the premarket approval regulations in part 814 by creating new subpart H. This final regulation prescribes the procedures for submitting HDE applications, amendments, and supplements; procedures for obtaining an extension of the exemption; and the criteria for FDA review and approval of HDE's. |
| www.fda.gov /oc/gcp/preambles/61fr33232.html (13985 words) |
