Source: http://www.emergogroup.com/resources/regulations-united-states/21-cfr-812
Timestamp: 2016-09-30 15:08:30
Document Index: 128434957

Matched Legal Cases: ['art 812', 'art 812', 'ART 812', '§ 812', '§ 812', '§ 812', '§ 812', '§ 812', '§ 812', '§ 812', '§ 812', '§ 812', '§ 812', '§ 812', '§ 812', '§ 812', '§ 812', '§ 812', '§ 812', '§ 812', '§ 812', '§ 812', '§ 812', '§ 812', '§ 812', '§ 812', '§ 812', '§ 812', '§ 812', '§ 812']

US FDA Quality System Regulation (QSR) – 21 CFR Part 812
US FDA (21 CFR Part 812): Investigational device exemptions (IDE)
[Code of Federal Regulations][Title 21, Volume 8][Revised as of April 1, 2014][CITE: 21CFR812]
Title 21 - Food and DrugsChapter I - Food and Drug AdministrationDepartment of Health and Human Services (HHS)Subchapter H - Medical DevicesPART 812 INVESTIGATIONAL DEVICE EXEMPTIONS
Subpart A--General Provisions § 812.1
§ 812.2
§ 812.3
- Labeling of investigational devices.
- Prohibition of promotion and other practices.
§ 812.10
- Waivers.
§ 812.18
- Import and export requirements.
- Address for IDE correspondence.
Subpart B--Application and Administrative Action § 812.20
§ 812.25
- Investigational plan.
§ 812.27
- Report of prior investigations.
§ 812.30
- FDA action on applications.
§ 812.35
- Supplemental applications.
§ 812.36
- Treatment use of an investigational device.
§ 812.38
- Confidentiality of data and information.
§ 812.40
- General responsibilities of sponsors..
§ 812.42
- FDA and IRB approval.
§ 812.43
- Selecting investigators and monitors.
§ 812.45
- Informing investigators.
§ 812.46
- Monitoring investigations.
§ 812.47
- Emergency research under 50.24 of this chapter.
Subpart D--IRB Review and Approval § 812.60
- IRB composition, duties, and functions.
§ 812.62
- IRB approval.
§ 812.64
- IRB's continuing review.
§ 812.65
- [Reserved].
§ 812.66
- Significant risk device determinations.
Subpart E--Responsibilities of Investigators § 812.100
- General responsibilities of investigators.
§ 812.110
- Specific responsibilities of investigators.
- Disqualification of a clinical investigator.
Subpart G--Records and Reports § 812.140
§ 812.145
[45 FR 3751, Jan. 18, 1980, as amended at 46 FR 8956, Jan. 27, 1981; 46 FR 14340, Feb. 27, 1981; 53 FR 11252, Apr. 6, 1988; 62 FR 4165, Jan, 29, 1997; 62 FR 12096, Mar. 14, 1997]
(4) There is reason to believe that the risks to the subjects are not outweighed by the anticipated benefits to the subjects and the importance of the knowledge to be gained, or informed consent is inadquate, or the investigation is scientifically unsound, or there is reason to believe that the device as used is ineffective.
(a) Changes in investigational plan -- (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 investigational device exemption (IDE) application in accordance with 812.20(a).
(d) FDA action on treatment IDE applications -- (1) Approval of treatment IDE's. Treatment use may begin 30 days after FDA receives the treatment IDE submission at the address specified in 812.19, unless FDA notifies the sponsor in writing earlier than the 30 days that the treatment use may or may not begin. FDA may approve the treatment use as proposed or approve it with modifications.
Sec. 812.65 [Reserved].
Authority: 21 U.S.C. 331, 351, 352, 353, 355, 360, 360c-360f, 360h-360j, 371, 372, 374, 379e, 381, 382, 383; 42 U.S.C. 216, 241, 262, 263b-263n.Source: 45 FR 3751, Jan. 18, 1980, unless otherwise noted.