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 or other Regulatory Body about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of the Products.

Device Master File means Clearside’s device master file number [***].

Examples of Device Master File in a sentence

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.
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).
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.
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.
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.
Contents may include proprietary information and can be referenced only with the specific permission of the Device Master File holder.
And (ii) failure to maintain the Device Master File will allow OctoPlus to acquire the Production Equipment for ****, ****.
Micron shall be solely responsible for ensuring the completeness and accuracy of the Device Master File, and shall expeditiously respond to and address any questions from the FDA regarding the contents of the Device Master File or Micron’s Approved Product.

More Definitions of Device Master File

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.

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).

Device Master File shall have the meaning set forth in Section 7.4(g);

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.

Device Master File means a device reference source submitted to the FDA as defined by 21 CFR 814.3.

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.