investigational device definition

investigational device means any device being assessed for safety and/or performance in a clinical investigation;

investigational device means a device that is assessed in a clinical investigation;

investigational device means a de- vice, including a transitional device, that is the object of an investigation.

Examples of investigational device in a sentence

• If we are required to collect data on human subjects, the FDA will require us to file an application for an Investigational Device Exemption, or IDE with the FDA and obtain IDE approval prior to commencing the human clinical trials.

• The performance of human surgeries with the SPORT Surgical System will require an Investigational Device Exemption (“IDE”) from the FDA, which must be submitted and approved in advance.

• In the case of the Celution System in Thermal Burn Injury this will require approval under the Investigational Device Exemption mechanism.

• The clinical trial using PoNS™ is considered to be of non-significant risk and, therefore, shall not require an Investigational Device Exemption submission.

• To the extent required by applicable Laws of the FDA, the Company or applicable Subsidiary has submitted to the FDA or otherwise has in effect an Investigational Device Exemption or amendment or supplement thereto for each clinical trial it has conducted or sponsored or is conducting or sponsoring; all such submissions were in material compliance with applicable Laws when submitted and no material deficiencies have been asserted by the FDA with respect to any such submissions.

More Definitions of investigational device

investigational device means a device that:

investigational device means a device that has been assessed in a clinical trial;

investigational device means a device, including a transitional device, that is the object of an investigation.

investigational device means a de- vice, including a transitional device, that is the object of an investigation.21 CFR Ch. I (4–1–16 Edition)

investigational device means a device that is assessed in a clinical investigation; (47)‘clinical investigation plan’ means a document that describes the rationale, objectives,

investigational device means a device that is assessed in a clinical investigation; c) Araştırma amaçlı cihaz: Bir klinik araştırma kapsamında değerlendirilmekte olan cihazı,

investigational device. The BioCardia® CardiAMP™ System, consisting of the CardiAMP cell separator and autologous bone marrow mononuclear cells delivered using the Helix transendocardial delivery catheter Sponsor: BioCardia, Inc. 000 Xxxxxxxx Xx Xxxxx X Xxx Xxxxxx, XX 00000 Consultant: As a Steering Committee (SC) consultant for the Study, I certify that I, my spouse or dependent children (check the appropriate box for each statement): [ ] Have [ X ] Do not have Have an ownership interest, stock options, or other financial interest (i.e., equity interest) in the Sponsor (public or non-public) that owns the Investigational Device being evaluated in the Study. [ ] Have [ X ] Do not have Have property or other financial interest (i.e., proprietary interest) in the Investigational Device being evaluated in the Study; including, but not limited to, a patent or patent interest, trademark, copyright, licensing agreement, or any arrangement tied to a current or future right to receive royalties associated with the development or eventual commercialization of the Investigational Device. [ ] Have [X ] Do not have Receive payments from the Sponsor that owns the respective Investigational Device during the term of the conduct of the Study; nor do I anticipate receiving payments from the Sponsor during a 1 year period following completion of the Study. Applicable payments (i.e., financial interest) include, but are not limited to, grants to fund projects or research or compensation in the form of monetary payments, equipment, or retainers for consultation or honoraria. If the response to any of the above statements is affirmative, completion of the Disclosure of Financial Interest is required. Xxxx Xxxxxxx Name of Consultant (Printed or Typed) /s/ Xxxxxxxx X. Xxxxxxx 2/15/2021 Signature of Consultant Date BioCardia CardiAMP Study Steering Committee Consulting Agr Xx. Xxxx Xxxxxxx Schedule 5 DISCLOSURE OF FINANCIAL INTEREST Title of Clinical Study: Randomized Controlled Pivotal Trial of Autologous Bone Marrow Mononuclear Cells Using the CardiAMP System in Patients with Post Myocardial Infarction Heart Failure (CardiAMP Heart Failure Trial)