Medical Device Reporting System definition

Medical Device Reporting System is a system of incident reporting to the Federal Food and Drug Administration (FDA), for all medical devices which are approved for inter-state commerce, where such incidents lead to corrective action relevant to medical devices. Medical Device Reporting Systems maintained by the Distributor shall comply with all applicable laws, the rules and regulations promulgated by the Federal or any State. This system is intended to allow data to be correlated between the FDA and manufactures to improve the protection of health and safety of patients, users and others by reducing the likelihood of the same type of adverse incident being repeated in different places at different times.
Sample 1Sample 2Sample 3

Examples of Medical Device Reporting System in a sentence

  • Data in the Medical Device Reporting System and the scientific literature indicate that some individuals are at risk of severe anaphylactic reactions to natural latex proteins.

  • Disproportionality analysis for signal detection of implantable cardioverter- defibrillator related adverse events in the FDA Medical Device Reporting System.

  • For example, your firm failed to develop, maintain and implement MDR procedures as a manufacturer of a medical device.Your response states your firm " is in the process of developing a documented Medical Device Reporting System.

  • See Section V.A.2 for information on FDA Adverse Event Reporting Syste (FAERS), Elecronic Medical Device Reporting System (eMDR), and Vaccine Adverse Event Reporting System (VAERS).

  • On May 23, 2022, a query was conducted of the Medical Device Reporting System (MDR) for product code LFL over a 20 year period with date limiters of January 01, 2002, to December 31, 2021.

Related to Medical Device Reporting System

  • 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:

  • Web Site Accessibility Standards/Specifications means standards contained in Title 1 Texas Administrative Code Chapter 206.

  • Web Site Accessibility Standards/Specifications means standards contained in Title 1 Texas Administrative Code Chapter 206.

  • 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.

  • 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.

  • Operational Manual means the manual referred to in Section 3.03 of this Agreement;

  • Quality system means documented organizational procedures and policies: internal audits of those policies and procedures: management review and recommendation for quality improvement.”

  • Marketing Information means marketing studies, marketing analyses, and similar research and information designed to identify potential customers and business relationships.

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

  • Good Clinical Practices means the FDA’s standards for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials contained in 21 C.F.R. Part 50, 54, 56, 312, 314, 320, 812, and 814 and (ii) “Good Laboratory Practices” means the FDA’s standards for conducting non-clinical laboratory studies contained in 21 C.F.R. Part 58.

  • Information Technology Systems means all information technology systems, Software, computers, workstations, databases, routers, hubs, switches, networks and other information technology equipment used or held for use in, or otherwise relating to, the Business.