This guideline only applies to the master files (MAFs) submitted to the Center for Devices and Radiological Health (CDRH). In addition, a master file may be considered when several applications may be submitted for different products which may use a common material or process, etc., such as the same sterilization method. To help preserve the trade secrets of the ancillary medical device industry and at the same time facilitate the sound scientific evaluation of medical devices, FDA established the device master file system. The other party, while willing to allow FDA's confidential review of this information, may not want the IDE, premarket notification, or PMA applicant to have direct access to the information. In order that a sound scientific evaluation may be made of the PMA, IDE, or other device submission, the review of data and other information related to the other party's product, facility, or manufacturing procedures is required. Often the applicant needs to use another party's product (e.g., ingredient, subassembly, or accessory) or facility in the manufacture of the device. Introduction to Master Files for Devices (MAFs)Ī premarket approval application (PMA) or an investigational device exemption application (IDE) usually contains data and other information that the applicant has developed and regards as trade secret or confidential commercial financial information.
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