Device Master File definition

Device Master File means all documentation necessary for TRANSMEDICS’ submission of a master file on the Products for 510K approval by the FDA and any equivalent Regulatory Agencies in other nations.
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Device Master File means materials that may be used to provide detailed information to the FDA about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of the Products or Material.
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Device Master File means Clearside’s device master file number [***].
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Examples of Device Master File in a sentence

  • The Profile 3.0 Device Master File (GSD) allows field devices from various manufacturers to be exchanged without having to reconfigure.

  • For each type or family of our products Amphenol Alden maintains a Device Master File that contains or references documents which demonstrate the conformity to the requirements for design and development and records for design and development changes.

  • For each type or family of our products Amphenol Alden maintains a Device Master File that contains or references documents which demonstrate the conformity to ISO 13485:2016 and applicable regulatory requirements.

  • The PROFIBUS-PA system requires a description of the device parameters, e.g. output data, input data, data format, data volume and supported transmission rate, so that it can integrate the field devices into the bus system.These data are contained in a Device Master File (GSD file) which is placed at the disposal of the PROFIBUS-PA master while the communication system is being commissioned.Device bitmaps can also be integrated.

  • FRESENIUS shall maintain a copy of all records needed for the portion of the Device Master File which relates to the Products.

  • TRANSMEDICS shall own a Device Master File and any registration with the regulatory agencies for the Products where the Products are determined to be medicinal products.

  • Provided the submission is sufficient to satisfy all regulatory requirements, SHL shall have the right in consultation with XPI to determine which documents and/or information may be contained within the Device Master File.

  • One of the tiers of documents supporting the quality manual is a " Device Master File" or " Device Master Record" (DMR) for each product type (see 4.4.5).

  • SURMODICS shall assist CABG’s regulatory compliance efforts by maintaining and updating a Device Master File with the FDA containing such information about the SURMODICS Reagents as is finally agreed between SURMODICS and the FDA.

  • Vericel may request that Matricel disclose certain Confidential Information directly to the FDA that Vericel believes will be required or that is required by FDA to be provided in the Device Master File (“MAF) or by direct correspondence with the FDA.


More Definitions of Device Master File

Device Master File means the Food and Drug Administration (FDA) Master File on PolyActive(TM) having formal FDA number ****. The first FDA filing of MAF PolyActive(TM) was done by IsoTis N.V. in February 2001 to the FDA Center for Devices and Radiological Health of the FDA. An update and amendment thereof was issued to the FDA by IsoTis N.V. in June 2006.
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Device Master File shall have the meaning set forth in Section 7.4(g);
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Device Master File means a master file as defined in 21 CFR §814.3, or a comparable submission of manufacturing or other information with respect to any medical device product (or any component thereof) to a Regulatory Authority made in accordance with applicable Laws by a Person who intends to authorize other Persons to rely on the information to support a submission to such Regulatory Authority without the holder of such master file having to disclose the information to the other Person(s).
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Device Master File means a device reference source submitted to the FDA as defined by 21 CFR 814.3.
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Device Master File means the device master file for Polymer intended to be filed or filed by Tepha with the U.S. Food and Drug Administration. * Denotes confidential information that has been omitted from the exhibit and filed separately, accompanied by a confidential treatment request, with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934.
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Device Master File means the detailed information concerning the Product which is submitted to the relevant Governmental Authority and which is intended for incorporation into the Regulatory Dossier.
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Related to Device Master File

  • Drug Master File or “DMF” is described in 21 C.F.R. Part 314.420. A DMF is a submission to the FDA that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.

  • Master File has the meaning set forth in the CAISO Tariff.

  • Death master file means the United States social security administration’s death master file or any other database or service that is at least as comprehensive as the United States social security administration’s death master file for determining that a person has died.

  • DMF means a drug master file, as provided for in 21 CFR § 314.420 or similar submission to or file maintained with the FDA or other Governmental Authority or Regulatory Authority that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.

  • HEPA filter means high-efficiency particulate air filters that are rated to achieve a minimum initial particle-removal efficiency of 99.97 per cent using ASTM F 1471– 93 or equivalent standard;

  • APIs means SAP application programming interface and accompanying or related Documentation, source code, tools, executable applications, libraries, subroutines, widgets and other materials made available by SAP or through SAP tools or SAP Software Development Kit (and all derivative works or modifications thereof) to Provider that allow Provider to integrate the Provider Service with the Cloud Service, including any access code, authentication keys or similar mechanisms to enable access of the APIs.

  • Regulatory Materials means regulatory applications, submissions, notifications, communications, correspondence, registrations, Regulatory Approvals or other filings made to, received from or otherwise conducted with a Regulatory Authority in order to Develop, Manufacture, or Commercialize a Licensed Product in a particular country or jurisdiction.

  • Clinical Data means the information with respect to the Licensed Product or the Licensed Compound made, collected or otherwise generated under or in connection with pre-clinical, clinical, or the post-Approval studies for the Licensed Compound or Licensed Product, including any data, reports and results with respect to any of the foregoing.

  • Death master file match means a search of the death master file that results in a match of the social security number or the name and date of birth of an insured, an annuity owner or a retained asset account holder.[PL 2017, c. 129, §1 (NEW).]

  • Manufacturing Process means any process for—

  • API means American Petroleum Institute.

  • Electronic device technology means a technology involving

  • Drug means (i) articles or substances recognized in the official United States Pharmacopoeia

  • Web spray adhesive means any aerosol adhesive that is not a mist spray or special purpose spray adhesive.

  • NEC Electronics products means any product developed or manufactured by or for NEC Electronics (as defined above).

  • Step therapy protocol means a protocol or program that establishes the specific

  • Study Data shall have the meaning set forth in Section 8.1.

  • Biological Samples means any physical samples obtained from Study Participants in accordance with the Protocol for the purposes of the Study.

  • Program Materials means the documents and information provided by the Program Administrator specifying the qualifying EEMs, technology requirements, costs and other Program requirements, which include, without limitation, program guidelines and requirements, application forms and approval letters.

  • Case file means a record that is assembled and maintained for each application approved for state cost sharing.

  • Study Materials means all the materials and information created for the Study, or required to be submitted to the Sponsor including all data, results, Biological Samples, Case Report Forms (or their equivalent) in whatever form held, conclusions, discoveries, inventions, know-how and the like, whether patentable or not, relating to the Study, which are discovered or developed as a result of the Study, but excluding the Institution’s ordinary patient records.

  • Label means a display of written, printed, or graphic matter upon the immediate container of any article. A requirement made by or under authority of this chapter that any word, statement, or other information appear on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any, of the retail package of such article or is easily legible through the outside container or wrapper.

  • NDA means a New Drug Application, as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding foreign application, registration or certification.

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

  • Spray buff product means a product designed to restore a worn floor finish in conjunction with a floor buffing machine and special pad.

  • Drug Product means a specific drug in dosage form from a known source of manufacture, whether