The investigational plan shall include, in the following order:
(a) Purpose. The name and intended use of the device and the objectives and duration of the investigation.
(b) Protocol. A written protocol describing the methodology to be used and an analysis of the protocol demonstrating that the investigation is scientifically sound.
(c) Risk analysis. A description and analysis of all increased risks to which subjects will be exposed by the investigation; the manner in which these risks will be minimized; a justification for the investigation; and a description of the patient population, including the number, age, sex, and condition.
(d) Description of device. A description of each important component, ingredient, property, and principle of operation of the device and of each anticipated change in the device during the course of the investigation.
(e) Monitoring procedures. The sponsor's written procedures for monitoring the investigation and the name and address of any monitor.
(f) Labeling. Copies of all labeling for the device.
(g) Consent materials. Copies of all forms and informational materials to be provided to subjects to obtain informed consent.
(h) IRB information. A list of the names, locations, and chairpersons of all IRB's that have been or will be asked to review the investigation, and a certification of any action taken by any of those IRB's with respect to the investigation.
(i) Other institutions. The name and address of each institution at which a part of the investigation may be conducted that has not been identified in paragraph (h) of this section.
(j) Additional records and reports. A description of records and reports that will be maintained on the investigation in addition to those prescribed in subpart G.
Notes of Decisions
Guckin v. Nagle, 259 F. Supp. 2d 406 (E.D. Pa. 2003).
“5 , and whether the consent materials comply with the provisions of 21 C.F.R. § 812.25 (g) and 21 C.F.R. § 50.”
Chmielewski v. Stryker Sales Corp., 966 F. Supp. 839 (D. Minnesota 1997).
“21 C.F.R. § 812.25 . The MDA contains an express preemption provision: Except as provided in subsection (b) of this section, no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement— (1)…”
Konrady v. Oesterling, 149 F.R.D. 592 (D. Minnesota 1993).
“Importantly, the Investigational Plan also describes evaluation criteria and documentation procedures which will enable the manufacturer and the FDA to evaluate the device as the investigation proceeds.”
Nexell Therapeutics, Inc. v. Amcell Corp., 143 F. Supp. 2d 407 (D. Del. 2001).
“See also 21 C.F.R. § 812.25 . After the FDA reviews the plan and grants an IDE, the manufacturer may begin the clinical trials.”
Isbell v. Medtronic, Inc., 97 F. Supp. 2d 849 (W.D. Tenn. 1998).
“Pursuant to 21 C.F.R. § 812.25 , the manufacturer must submit a detailed statement regarding the intended use of the device and the objectives and planned duration of the investigational study; a written protocol describing the methodology to be used and an analysis of the…”
Chambers v. Osteonics Corp., 917 F. Supp. 624 (S.D. Ind. 1996).
“Although regulations prohibit the inclusion of exculpatory language by which a subject waives or appears to waive any legal rights, the consent form is required to at least alert the subject to the possibility of the loss of certain legal rights. See 21 C.”
Teal v. Argon Med. Devices, Inc. (E.D. Mich. 2021).
“Judicial Notice As a preliminary matter, Rex requests that the Court take judicial notice of several FDA documents: (1) FDA website publication on Pre-market Notification/510(k) Clearance Process; (2) Guidance for Cardiovascular Intravascular Filter 510(k) Submissions; and (3)…”
Suttman-Villars v. Argon Med. Devices, Inc (D.N.M. 2021).
“II Discussion As an initial matter, Rex requests that the Court take judicial notice of three FDA documents: (1) an “FDA website publication on Pre-market Notification/5 10(k) clearance process;” (2) the FDA’s “Guidance for Cardiovascular Intravascular Filter 510(k)…”
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