Valid Scientific Evidence definition

Valid Scientific Evidence means evidence from well-controlled investigations,
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Valid Scientific Evidence means evidence from well-controlled investigations, partially controlled studies, studies and objective trials without matched controls, well- documented case histories conducted by qualified experts, and reports of significant human experience with a marketed device, from which it can fairly and responsibly be concluded by qualified experts that there is reasonable assurance of the safety and effectiveness of a device under its conditions of use.
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Valid Scientific Evidence means evidence from well-controlled investigations, partially controlled studies, studies and objective trials without matched controls, well- documented case histories conducted by qualified experts, or reports of significant human experience with a marketed device, from which it can fairly and responsibly be concluded by qualified experts that there is reasonable assurance to substantiate that a representation is true.
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Examples of Valid Scientific Evidence in a sentence

  • Valid Scientific Evidence BackgroundEvidence submitted to FDA, in a PMA or a 510(k) notification, regarding the use of a medical device in the treatment or diagnosis of disease is obtained from clinical trials, which are research studies involving patients.

  • Complete removal of mesh may not be possible and additional surgeries may not always fully correct the complications However, for Post-Effective Date Urogynecologic Surgical Mesh, a non-verbatim description of these risks may include, but are not limited to, the risks listed in the bullet points above, depending upon the available Valid Scientific Evidence.

  • However, for Post- Effective Date Urogynecologic Surgical Mesh, BARD may, in any Marketing Materials, represent or imply that such Urogynecologic Surgical Mesh is “soft” or that it has “multidirectional elasticity” within the body after implantation or use any other phrases having an equivalent meaning, if such statement is supported by Valid Scientific Evidence.

  • However, for Post- Effective Date Urogynecologic Surgical Mesh, BARD may, in any Marketing Materials, representor imply that such Urogynecologic Surgical Mesh is “soft” or that it has “multidirectional elasticity” within the body after implantation or use any other phrases having an equivalent meaning, if such statement is supported by Valid Scientific Evidence.

  • Resulting prevalences were consistent with those estimated for China in GBD 1990.WPRO B3 Recorded RA mortality is high.

  • Complete removal of mesh may not be possible and additional surgeries may not 22 always fully correct the complications 23 However, for Post-Effective Date Urogynecologic Surgical Mesh, a non-verbatim 24 description of these risks may include, but are not limited to, the risks listed in the bullet points 25 above, depending upon the available Valid Scientific Evidence.

  • CODE §§17.41 et seq.3.4. BARD shall not, in any Marketing Materials, make any claim comparing safety or efficacy clinical outcomes with the use of Urogynecologic Surgical Mesh to any non-mesh procedure safety or efficacy clinical outcomes, unless any such representation is supported by Valid Scientific Evidence.

  • For example, artisans such as weavers, jewellers, shoe makers, brass utensil manufacturers, and stone carvers in the surveyed areas rely on raw materials brought from other regions of India.

  • However, for Post-Effective Date Urogynecologic Surgical Mesh, BARD may, in any Marketing Materials, represent or imply that Significant Complications can be eliminated with surgical experience or technique alone, if such statement is supported by Valid Scientific Evidence.

  • Publications meeting Valid Scientific Evidence Definition for Durations > 6 hours Pub# Publication Citation1 Abusaid GH, Ahmad M.


More Definitions of Valid Scientific Evidence

Valid Scientific Evidence means evidence from well-controlled investigations, partially controlled studies, studies and objective trials without matched controls, well- documented case histories conducted by qualified experts, and reports of significant human experience with a marketed device, from which it can fairly and responsibly be concluded by
Sample 1Sample 2Sample 3
Valid Scientific Evidence means evidence from well-controlled investigations, partially controlled studies, studies and objective trials without matched controls, well- documented case histories conducted by qualified experts, or reports of significant human
Sample 1

Related to Valid Scientific Evidence

  • clinical evidence means clinical data and clinical evaluation results pertaining to a device of a sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefit(s), when used as intended by the manufacturer;

  • Clinical evaluation means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer;

  • Radiopharmaceutical quality assurance means, but is not limited to, the performance of appropriate chemical, biological, and physical tests on potential radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment, authentication of product history, and the keeping of proper records.

  • Public research university means Rutgers, The State University

  • Therapeutic school means a residential group living facility:

  • Clinical nurse specialist means a registered nurse with relevant post-basic qualifications and 12 months’ experience working in the clinical area of his/her specified post-basic qualification, or a minimum of four years’ post-basic registration experience, including three years’ experience in the relevant specialist field and who satisfies the local criteria.

  • Peer-reviewed medical literature means a published scientific study in a journal or other publication in which original manuscripts have been published only after having been critically reviewed for scientific accuracy, validity and reliability by unbiased independent experts, and that has been determined by the international committee of medical journal editors to have met the uniform requirements for manuscripts submitted to biomedical journals. Peer-reviewed medical literature does not include publications or supplements to publications that are sponsored to a significant extent by a pharmaceutical manufacturing company or health carrier.

  • Medical evaluation means the process of assessing an individual's health status that includes a medical history and a physical examination of an individual conducted by a licensed medical practitioner operating within the scope of his license.

  • Objective medical evidence means reports of examinations or treatments; medical

  • Clinical Staff means those employees of a provider who are responsible for providing clinical services to clients.

  • Licensed mental health professional or "LMHP" means a physician, licensed clinical psychologist, licensed professional counselor, licensed clinical social worker, licensed substance abuse treatment practitioner, licensed marriage and family therapist, certified psychiatric clinical nurse specialist, licensed behavior analyst, or licensed psychiatric/mental health nurse practitioner.

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • Biomarker means a parameter or characteristic in a patient or Patient Sample, the measurement of which is useful (a) for purposes of selecting appropriate therapies or patient populations or monitoring disease susceptibility, severity or state, or monitoring therapies for such patient and/or (b) for predicting the outcome of a particular treatment of such patient.

  • Soil scientist means an individual duly qualified in accordance with standards set by the Federal Office of Personnel Management.