(a) Approval or disapproval. FDA will notify the sponsor in writing of the date it receives an application. FDA may approve an investigation as proposed, approve it with modifications, or disapprove it. An investigation may not begin until:
(1) Thirty days after FDA receives the application at the address in § 812.19 for the investigation of a device other than a banned device, unless FDA notifies the sponsor that the investigation may not begin; or
(2) FDA approves, by order, an IDE for the investigation.
(b) Grounds for disapproval or withdrawal. FDA may disapprove or withdraw approval of an application if FDA finds that:
(1) There has been a failure to comply with any requirement of this part or the act, any other applicable regulation or statute, or any condition of approval imposed by an IRB or FDA.
(2) The application or a report contains an untrue statement of a material fact, or omits material information required by this part.
(3) The sponsor fails to respond to a request for additional information within the time prescribed by FDA.
(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 inadequate, or the investigation is scientifically unsound, or there is reason to believe that the device as used is ineffective.
(5) It is otherwise unreasonable to begin or to continue the investigation owing to the way in which the device is used or the inadequacy of:
(i) The report of prior investigations or the investigational plan;
(ii) The methods, facilities, and controls used for the manufacturing, processing, packaging, storage, and, where appropriate, installation of the device; or
(iii) Monitoring and review of the investigation.
(c) Notice of disapproval or withdrawal. If FDA disapproves an application or proposes to withdraw approval of an application, FDA will notify the sponsor in writing.
(1) A disapproval order will contain a complete statement of the reasons for disapproval and a statement that the sponsor has an opportunity to request a hearing under part 16.
(2) A notice of a proposed withdrawal of approval will contain a complete statement of the reasons for withdrawal and a statement that the sponsor has an opportunity to request a hearing under part 16. FDA will provide the opportunity for hearing before withdrawal of approval, unless FDA determines in the notice that continuation of testing under the exemption will result in an unreasonble risk to the public health and orders withdrawal of approval before any hearing.
[45 FR 3751, Jan. 18, 1980, as amended at 45 FR 58842, Sept. 5, 1980]
Notes of Decisions
Goodlin v. Medtronic, Inc., 167 F.3d 1367 (11th Cir. 1999).
“See 21 C.F.R. § 812.30 (b)(4). 3 . For a detailed description of the PMA process, see Worthy v.”
Blinn v. Smith & Nephew Richards, Inc., 55 F. Supp. 2d 1353 (M.D. Fla. 1999).
“21 C.F.R. § 812.30 . IDEs are specifically exempted from many of the requirements to which they would otherwise be subject as Class III medical devices.”
Isbell v. Medtronic, Inc., 97 F. Supp. 2d 849 (W.D. Tenn. 1998).
· cites it 4× “Based on the information submitted, the FDA will approve the device under the IDE unless “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 inadequate, or the *853…”
Nexell Therapeutics, Inc. v. Amcell Corp., 143 F. Supp. 2d 407 (D. Del. 2001).
“IDE studies that are not scientifically sound in the context of device development, and will thus result in prolonging the investigation of your device, will be disapproved under 21 C.F.R. § 812.30 (b). Therefore, we request that you refrain from supplying your device to…”
Yale-New Haven Hosp. v. Leavitt, 470 F.3d 71 (2d Cir. 2006).
“3(m), if it determines that “[t]here is reason to believe that the risks to the subjects are not outweighed by the anticipated benefits to the subjects and the *85 importance of the knowledge to be gained,” 21 C.F.R. 812.30(b)(4). Use of significant risk devices in clinical…”
Robinson v. Endovascular Tech., Inc., 190 Cal. App. 4th 1490 (Cal. Ct. App. 2010).
· cites it 3× “( 21 C.F.R. § 812.30 (1994).) *1494 After the IDE application has been approved, the FDA prohibits any deviation from the investigational plan, design, manufacturing techniques, clinical protocol, warnings or consent form which could potentially affect clinical subjects unless…”
Yale-New Haven Hosp. v. Leavitt, 470 F.3d 71 (2d Cir. 2006).
“3(m), if it determines that "[t]here 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," 21 C.F.R. 812.30(b)(4). Use of significant risk devices in clinical trials…”
Mize v. Mentor Worldwide LLC (Cal. Ct. App. 2020).
“( 21 C.F.R. § 812.30 .) If the FDA approves an IDE application, few changes to the investigational plan are permitted.”
Goodlin v. Medtronic, Inc., 167 F.3d 1367 (11th Cir. 1999).
“See 21 C.F.R. § 812.30 (b)(4). 3 For a detailed description of the PMA process, see Worthy v.”
— 21 C.F.R. § 812.30(b)(4) — 2 cases
Yale-New Haven Hosp. v. Leavitt, 470 F.3d 71 (2d Cir. 2006).
“3(m), if it determines that “[t]here is reason to believe that the risks to the subjects are not outweighed by the anticipated benefits to the subjects and the *85 importance of the knowledge to be gained,” 21 C.F.R. 812.30(b)(4). Use of significant risk devices in clinical…”
Yale-New Haven Hosp. v. Leavitt, 470 F.3d 71 (2d Cir. 2006).
“3(m), if it determines that "[t]here 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," 21 C.F.R. 812.30(b)(4). Use of significant risk devices in clinical trials…”
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