CFR section
21 CFR 812.35(a)(1): Supplemental applications
PART 812-INVESTIGATIONAL DEVICE EXEMPTIONS · Subpart B-Application and Administrative Action
Key facts
| Citation | 21 CFR 812.35(a)(1) |
|---|---|
| Section | Supplemental applications |
| Part | PART 812-INVESTIGATIONAL DEVICE EXEMPTIONS |
| Subpart | Subpart B-Application and Administrative Action |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices, Drugs, General |
| Regulation text (excerpt) | (1) Changes requiring prior approval. Except as described in paragraphs (a)(2) through (a)(4) of this section, a sponsor must obtain approval of a supplemental application under § 812.30(a), and IRB approval when appropriate (see §§ 56.110 and 56.111 of this chapter), prior to implementing a change to an investigational plan. If a sponsor intends to conduct an investigation that involves an exception to informed consent under § 50.24 of this chapter, the sponsor shall submit a separate… |
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