DEVICE MASTER FILE (MAF)
Companies that sell materials, components or manufacturing services should consider the benefits of a DEVICE MASTER FILE (MAF) with the Center for Devices and Radiological Health (CDRH). A MASTER FILE is a service for your customers but also helps you to maintain control on your company’s proprietary information. Consider the content of a Device Master File, how it is used by the FDA and your customers, and how it provides a shield around your company’s intellectual property, while providing the quality information your customer needs for their medical device application. Originally conceived as a means for submitting data in support of a PreMarket Approval Application (PMAA), Master Files also serve to support Investigational Device Applications, 510(k) applications and deNovo submissions. The Device Master File owner controls the content and access to the file by way of a letter to the customer and FDA indicating the scope of access to the proprietary information.
A Device Master File typically provides proprietary data about a material, a component, or a manufacturing process that the holder of the Master File wishes to make available to FDA on behalf of the customer, without relinquishing control of the contents to the customer. The proprietary information can take many forms, including proprietary test results and manufacturing processes. A typical material MAF might include proprietary chemical test results, formulations, biocompatibility and toxicology test results, literature articles and comparative analysis to other materials. Components, such as batteries, may have reliability and compatibility data, including decay curves, explosive and altitude testing results and storage information. Contract manufacturers may include process validation protocols and reports, cleaning validation reports and other proprietary manufacturing information. Process flow charts, raw material suppliers and process risk analysis documents are also included in aDevice Master File. Consider the content of a Device Master File can be any proprietary information that FDA may need in reviewing your customer’s medical device submission.
Only customers that you designate by letter may have access to your Device Master File at the FDA. You can indicate in the letter the portions of the Device Master File to which you will allow the access and for the specific device submission; so customers have to request access each time it is referenced. Some suppliers charge their customers for access to the Device Master File, but this has become less common. The value of the access to the Device Master File is only worth the amount of money that your customer saves by having access to your MAF on file with the US FDA. If you don’t manage the content to keep it fresh and accurate, there is no value to your customer. The best Device Master Files are organized with a detailed Table of Contents which allows the customer to know whether or not the contents may be of value to their regulatory efforts. Typically the holder of the MAF will provide a copy of the Table of Contents at no charge to prospective customers to demonstrate the value of the file contents. Although unusual, a device manufacturer may choose to file their own MAF in order to facilitate review by different divisions to the same corporate quality information.
HOW FDA USES the CONTENT:
FDA will only access your Device Master File when your customer makes a submission to the Agency and includes your access letter. Only at that time, as the FDA reviews the submission and as the customer designates within the submission, the FDA reviewer will open and review the referenced contents. This is when the customer will need to be specific as to how the content in the Master File supports their requirements for the submission. As an example, if the applicant contends that the material’s biocompatibility testing is included in the master file, that section of the MAF would be referenced with a justification for why these data are relevant to the device under review. If the FDA needs more data, the reviewer states that to the applicant. If the applicant should request of the MAF holder to add more information and the holder agrees, then the existing File may be supplemented as an amendment to the MAF. Some Master File holders might decide that the additional testing is the responsibility of the customer, or both parties might strike an agreement to share costs and data access.
PROTECTING DATA in the MAF:
Your proprietary information is more secure in the DEVICE MASTER FILE than it is under a confidential disclosure to your customers because the only time the information is accessed by the FDA is when a submission is filed. However, FDA has made it clear that “under the Freedom of Information Act (FOI), information in 510(k)s, IDEs, PMAs and other device-related submissions, such as MAFs, is subject to public disclosure unless determined by FDA to be trade secret or confidential commercial or financial information within the meaning of 21 CFR 20.61 or otherwise prohibited from public disclosure.”
FDA is required to publish a detailed summary of the safety and effectiveness data forming the basis for the FDA decision to approve, or deny a customer’s PMA (other submission types have different disclosure requirements.) Therefore it is possible that some information included in the publication would be derived from the contents of the MAF. To ensure the best protection of proprietary data, MAF holders should identify information in their MAFs which are trade secret or confidential commercial/financial information within the meaning of 21 CFR 20.61. Of course, MAF information already in the public domain is subject to disclosure (e.g., any published literature, catalog, or product specification sheets distributed by the MAF holder to potential customers).
HOW TO SUBMIT A MAF:
There is no fee to submit a Device Master File to the FDA, nor any charge to make amendments. There are however, certain requirements in the file submission so that FDA can log-in the MAF in an expedient manner. Each MAF is given a file number that must be used on the access letters. Maintaining the data within the Device Master File as current and of value to your customers should be simple if the MAF is laid out initially with a comprehensive outline. Not all sections of the MAF need be filed at the same time, as some companies find that filing the portions needed by the first customer helps to expedite the process and “break the ice”. It is important to realize that FDA does not “approve” the data in the Device Master File in advance when it is filed. It is only reviewed by particular FDA reviewers when the customer submits the access letter, and only for that particular submission. There is no limit to the number of MAF that a single company may file.
If you think your company would like to know more about creating and filing a Device Master File, you can find additional information at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketApprovalPMA/ucm142714.htm
or contact us at Paladin Medical, Inc. We can help you get started, work with your staff to compile and file the MAF and help you to decide the content that can best help your customers succeed. We have outline templates and guides to maintaining a current MAF. www.paladinmedical.com
©Paladin Medical, Inc. 2015