Medical Device Report definition

Medical Device Report or “MDR” means a report filed with FDA to communicate an event when Seller or Buyer becomes aware (as such phrase is defined in 21 CFR 803.3(c)) of information that reasonably suggests that one of its marketed Products:
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Medical Device Report means all reports required to be submitted to FDA consistent with 21 CFR Part 803. “Merger Consideration Spreadsheet” has the meaning set forth in S ection 5.1(b).
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Medical Device Report means all reports required to be submitted to FDA consistent with 21 CFR Part 803.
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Examples of Medical Device Report in a sentence

  • Complaints are evaluated to de- termine whether the complaint rep- resents an event which is required to be reported to FDA under part 803 of this chapter, Medical Device Report- ing.(b) Each manufacturer shall review and evaluate all complaints to deter- mine whether an investigation is nec- essary.

  • Complaints are evaluated to de- termine whether the complaint rep- resents an event which is required to be reported to FDA under part 803 of this chapter, Medical Device Report- ing.

  • The FDA Medical Device Report (MDR) system includes reports of bougies rupturing and leaving mercury inside the patient as well as in the room.

  • Among its earliest reports, Allergan submitted a Medical Device Report (“MDR”) involving a case of BIA-ALCL to the FDA on 6/23/2010.

  • This amount, along with the approximately $9 million in outstanding Manitoba Savings Bonds of previous issues, will bring our total issue of saving bonds of the province to between 45 and 50 million.

  • Any serious adverse event that requires a Medical Device Report will be reported by the Sponsor to the FDA in accordance with Sponsor’s Medical Device Reporting SOP.

  • Each device failure/adverse event will be assessed for possible reporting as a Medical Device Report (MDR), and a determination will be made in accordance with the Sponsor’s standard operating procedure.

  • CL and HJL agree to notify the other within two (2) business days of receipt from any customer of any complaint or fileable Medical Device Report (“MDR”) relating to the Product.

  • Medical Device Report (MDR) 3006028115-2019-00002 was filed after a patient died and a malfunction which resulted in delay of therapy due to false negative results of the firm's (b)(4) assays using the VERIGENE SP instrument was reported.

  • You must submit any written report or additional information required under this part to FDA, CDRH, Medical Device Report- ing, P.O. Box 3002, Rockville, MD 20847–3002.

Related to Medical Device Report

  • 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:

  • 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.

  • 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.

  • Consumables and medical devices means (consumables) items that require regular replacement (e.g. batteries) to keep a medical device (such as a hearing aid) operational. Many medical devices require consumables.

  • 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.

  • 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;

  • Clinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient;

  • Forensic analysis means the practice of gathering, retaining, and analyzing computer-related data for investigative purposes in a manner that maintains the integrity of the data.

  • Licensed behavior analyst means a person who holds current certification or meets the standards to be certified as a board certified Behavior Analyst or a board certified Assistant Behavior Analyst issued by the Behavior Analyst Certification Board, Inc., or any successor in interest to that organization and whom the Board of Psychological Examiners licenses as a Behavior Analyst.

  • Analytical x-ray system means a group of components utilizing x-rays to determine the elemental composition or to examine the microstructure of materials.

  • Clinical Data means the information concerning the safety or performance that is generated from the use of a device and that are sourced from the following:

  • Investigational Medicinal Product means the study drug or control material as defined in the Protocol.

  • Diagnostic clinical procedures manual means a collection of written procedures that describes each method (and other instructions and precautions) by which the licensee performs diagnostic clinical procedures; where each diagnostic clinical procedure has been approved by the authorized user and includes the radiopharmaceutical, dosage, and route of administration.

  • Drug abuse means any pattern of pathological use of drugs that causes impairment in social or occupational functioning, or that produces physiological dependency evidenced by physical tolerance or by physical symptoms when it is withdrawn.

  • Drug test means a test designed to detect the illegal use of a controlled substance.

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • 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.

  • Marketing Materials has the meaning ascribed thereto in NI 41-101;

  • Diagnostic source assembly means the tube housing assembly with a beam-limiting device attached.

  • Drug therapy management means the review of a drug therapy regimen of a patient by one or more pharmacists for the purpose of evaluating and rendering advice to one or more practitioners regarding adjustment of the regimen.

  • Phase I Clinical Trial means a study in humans which provides for the first introduction into humans of a product, conducted in normal volunteers or patients to generate information on product safety, tolerability, pharmacological activity or pharmacokinetics, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(a) or its foreign equivalents.

  • Protocols means written directions and orders, consistent with the department’s standard of care, that are to be followed by an emergency medical care provider in emergency and nonemergency situations. Protocols must be approved by the service program’s medical director and address the care of both adult and pediatric patients.

  • Phase 4 Clinical Trial means a Clinical Study in any country which is conducted after Regulatory Approval of a product has been obtained from an appropriate Regulatory Authority, consisting of trials conducted voluntarily for enhancing marketing or scientific knowledge of an approved indication and trials conducted due to request or requirement of a Regulatory Authority.

  • COVID-19 test means a viral test for SARS-CoV-2 that is:

  • Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.