The FDA has released a guidance document concerning electronic study data, providing medical device companies with a definitive format for submitting clinical and non-clinical data to the various branches of the Agency, including the Center for Biologics Evaluation and Research (CBER) and the Center for Devices and Radiological Health (CDRH). The FDA is encouraging manufacturers to adopt these new data submission standards early in the product development cycle.
One of the main goals of the draft guidance, ‘Providing Regulatory Submissions in Electronic Format – Standardized Study Data’, released in February 2012, is to improve the FDA’s efficiency at processing new drug applications, 510(k)s, pre-marketing approval applications and other important submissions. The sheer volume of data received by the Agency as supporting documentation for these processes essentially demands a standardized formatting method. Standardization improves analysis and facilitates more informed decision-making on the part of reviewers.
What does the guidance mean for medical device manufacturers? Medical device companies will be required to provide standardized study submission plans that describe the data standards used, and certain standards (including CDRH Event Problem Codes) should become a regular feature of study documentation. Data must be validated prior to submission (for both technical and business standard conformity), and any data that resists easy standardization must be brought to the attention of reviewers and explained.
These requirements are easy enough for manufacturers to follow, and could in fact have the pleasant side effect of improving efficiency on the manufacturer side of the submission process as well – particularly when it comes time to go back and forth with the FDA concerning the clarification of data or outcomes. The guidance document references technical support teams that will be staffed by CDRH and other Administration personnel in order to answer questions regarding the classification and standardization of medical device data.
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Aptiv Solutions Blogging Team