Device master file

Ticona Topas. FDA Drug Master File DMF 12132, established, FDA Device Master File, MAF 1043, estab-hshed. 

Conclude this process by documenting flie selection. Include all of the scoring sheets, concept descriptions, and related data. This will become part of the medical device master file, and perhaps play a role in getting product approval and it will be useful when concepts need to be reconsidered later in order to make final decisions. 

The Food and Drug Administration requires that for each device there be a device master file. The length and breadth of that rule becomes clearer when it is explained that the file need not be... 

Investigational New Drug Applications (INDs), NDAs, Premarket Approval Applications (PMAs), Premarket Notifications (5 lO(k)s), Investigational Device Exemptions (IDEs), Biological Master Files (BMFs) and DMFs that are referenced in the current application. 

A timely and systematic approach is needed for the independent review of excipients to encourage the development of new excipients. A number of independent review models are used in other industries, such as food, cosmetics, and medical devices, and could be adapted to the review of excipients. IPEC is currently surveying its members to determine which system might be most useful (28), and IPEC has developed an Excipient Master File Guide to standardize and harmonize the information needed to review a new excipient (29). The format of the master file is modeled after the electronic ICH CTD for presenting chemistry, manufacturing, and controls and safety information. 

The purpose of this document is to list the data needed for orthopedic devices containing UHMWPE. These data should be included in premarket notifications (510k), Investigational Device Exemptions (IDE) applications. Premarket Approval (PMA) applications, reclassification petitions, and master files to aid FDA in determining the substantial equivalence and/or safety and effectiveness of UHMWPE in implantable orthopedic devices. In this document UHMWPE is referred to as polyethylene (PE). 

Many manufacturers can provide biocompatibility data either in their literature or as an FDA Master File. Often material manufacturers will advertise that a material meets class IV biocompatibility requirements. Class VI requirements are an old set of tests published in the U.S. Pharmacopeia that were developed for testing food packaging. They are similar to the cytotoxicity, acute toxicity, and subchronic toxicity tests. However, the data provided by a materials manufacturer are on samples that have not seen the processing and storage of the device. The data simply are an indication that the material can pass the initial set of biocompatibility tests if processed appropriately. 

Failure to maintain procedures to ensure that the device design is correctly translated into production specifications. For example, the [redacted] software source code version 1.6 did not go through a formally documented design transfer process. The source code s electronic file transfer to the master chip before production release was not documented and the approved sonrce code version 1.6 (hardcopy or electronic file) was not retained nnder Docnment Controls. 

The first item allows you to select which devices (hardware and/or software synthesizers) are used for MIDI playback and tune code generation. Selected items will show up on the device list in the track header for MIDI tracks. Although you can select from a number of devices for playback, only the default Master hus (DirectX SoftSynth) will allow you to render projects with MIDI files. 

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