Class III medical device definition

Class III medical device means a medical device that the FDA has
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Examples of Class III medical device in a sentence

  • EB-301 is regulated as a Class III medical device and is anticipated to enter a clinical market authorization registration study in China in 2H 2022 to confirm its safety and effectiveness.

  • From time to time, the FDA may disagree with the classification of a new Class I medical device and require the manufacturer of that device to apply for approval as a Class II or Class III medical device.

  • The costs of establishing compliance with QSR’s, cGMP and other regulatory standards for a Class III medical device pursuant to Section 2.2(d) will be borne by Fenwal and amortized in the Cost of Goods for all Platelet Sets and Plasma Sets over a five-year period.

  • To date, the FDA has indicated that it intends to regulate the Aastrom CPS for stem cell therapy as a Class III medical device through the Center for Biologics Evaluation and Research.

  • Supplier may share with Sientra information about any Supplier performed or sponsored in vitro studies, trials and assessments relating to the Products and shall notify Sientra of any actually known facts, circumstances or events that will result in the loss of Class III medical device status for the Breast Implant Products.

  • Ulti- mately, the FDA is authorized to grant premarket ap- proval for a Class III medical device only if the agency finds that there is “reasonable assurance” that the device is “safe and effective.” 21 U.S.C. § 360e(d)(2).

  • If during the term of this Agreement the Company decides to engage in Class III medical device manufacturing at either or both of the Reading Facilities, the parties agree to meet and negotiate the requirements for these positions.

  • It is undisputed that a heart valve is a Class III medical device.

  • To date, the FDA has indicated that it intends to regulate the Aastrom CPS product for stem cell therapy as a Class III medical device through the Center for Biologics Evaluation and Research.

  • A 510(k) concurrence will be granted if the submitted information establishes that the proposed device is "substantially equivalent" to a legally marketed Class I or Class II medical device or a Class III medical device for which the FDA has not required PMAs. The Company has received FDA concurrence under Section 510(k) for the PerioTemp.

Related to Class III medical device

  • medical device means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

  • in vitro diagnostic medical device means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:

  • Class III Gaming means Class III Gaming as defined in the IGRA.

  • Clinical Development means the conduct of clinical trials in humans to assess the dosing, safety and/or efficacy of the Product, including but not limited to Phase I Clinical Trials, Phase II Clinical Trials, Phase Ill Clinical Trials and Phase IV Clinical Trials.

  • Nuclear medicine technologist means an individual who holds a current certification with the American Registry of Radiological Technologists or the Nuclear Medicine Technology Certification Board.