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 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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Examples of Device Master File in a sentence

  • SHL shall assist XPI in maintaining and submitting a Device Master File (MAF) to the FDA and other Regulatory Authorities that may be used to provide detailed information about facilities or articles used in the manufacturing, processing, packaging, and storing of the Devices.

  • 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.

  • Contents may include proprietary information and can be referenced only with the specific permission of the Device Master File holder.

  • The ACI-Maix-Membrane Products shall be manufactured and tested in accordance current device GMP regulations and the information contained in the FDA Device Master File (MAF).

  • Licensee shall pay Tepha a total sum of * to support Tepha's research and developments efforts and completion of filing of the Device Master File for the Polymer with the FDA, which said Research and Development payments shall be deemed earned and due as follows: * which the parties acknowledge has been paid prior to the Effective Date; and * earned and due at the rate of * per month beginning January 1, 2003; and * upon the completion of filing of the Device Master File with the FDA.

  • Upon execution of this Agreement, Tepha will use diligent efforts to complete and file a Device Master File with the FDA for the Polymer, and to maintain and update the Device Master File for the remainder of this Agreement.

  • Process/product and cleaning validation for the manufacture of the Polymer shall be performed by Tepha in accordance with the Device Master File.

  • For clarity, Clearside will not assign or transfer to Bausch Health the Device Master File.

  • Medtronic will file a Device Master File with the FDA for the System which will contain all relevant device data related to the use of the System with the Drug.

  • Vyteris shall be primarily responsible and shall have the principal right to interface with the FDA or other regulatory authority with respect to the Device Master File for the Product, and may communicate with the FDA or any regulatory authority regarding the Device Master File, provided that Vyteris shall provide copies to Ferring of all such communications.


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 means a device reference source submitted to the FDA as defined by 21 CFR 814.3.
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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 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 shall have the meaning set forth in Section 7.4(g);
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Device Master File means Clearside’s device master file number [***].
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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.

  • DMF means any drug master file filed with the FDA, and any equivalent filing in other countries or regulatory jurisdictions.

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

  • Electronic Product Code™ (EPC) means an identification scheme for universally identifying physical objects via RFID tags and other means. The standardized EPC data consists of an EPC (or EPC identifier) that uniquely identifies an individual object, as well as an optional filter value when judged to be necessary to enable effective and efficient reading of the EPC tags. In addition to this standardized data, certain classes of EPC tags will allow user-defined data. The EPC Tag Data Standards will define the length and position of this data, without defining its content.

  • 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 materials developed or compiled in preparation for Regulatory Authority meetings, regulatory applications, submissions, dossiers, notifications, registrations, Regulatory Approvals and/or other filings made to or with, or other approvals granted by, a Regulatory Authority that are necessary or reasonably desirable for the Development, manufacture, market, sale, or Commercialization of a Licensed Product in a particular regulatory 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.

  • Investigational Product means the Study Drug identified above and the control material, as further detailed in the Protocol;

  • Manufacturing Process means any process for—

  • API means American Petroleum Institute.

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

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

  • 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.

  • 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

  • NDA means a New Drug Application, as defined in the regulations promulgated by the United States Food and Drug Administration, or any foreign equivalent thereof.