For hopeful applicants, the FDA submission process for medical devices is a long and complex one. However, a study ran by Booz Allen Hamilton, an American technology consulting firm, has some timely recommendations to revise the procedure. Administrated under the third Medical Device User Fee Amendments (MDUFA III), the measures outline a total of four ideas that would streamline and simplify applying.
How to Improve the FDA Medical Device Process
1. The FDA needs developed principles and established, standardized norms in order to have uniformity in decision-making throughout the review process. As it stands, there is much ambiguity and personal bias injected into what gets the green light and what doesn’t. According to the study, this needs to be resolved.
2. By the same token, a multipronged, holistic approach needs to be applied to the lifecycle management activities inherently tied to the application process. By addressing a total of five components linked to application quality, the FDA can approach objective standardization of the content it reviews on a grand scale. This improves the quality of the applications themselves, helping save people from submitting time-wasting applications that would get rejected otherwise.
3. Mandatory training needs to be provided in no less than three primary IT systems already in place by MDUFA III. There is a differential in knowledge between those submitting research and data to the FDA and those at the FDA receiving it. The agents of the FDA need a more thorough understand of the IT systems being used throughout the industry, and it’s unfair to penalize applicants because of the IT systems they chose.
4. Metrics need to be developed to assess the ongoing review process as a whole. The FDA isn’t some sentient, mysterious Wizard-of-Oz-like entity concerned with judging and reviewing – it’s made of people. Fallible, busy, opinionated human beings. Methods to analyze and chart personnel-related issues like training satisfaction, learning and staff behavior changes should be important, as they affect the way employees in the FDA consider, sort, and judge applications.
If written into the regulations, the above proposals would arguably change the landscape of the FDA’s application process, opening the floodgates of innovation. By motivating more people to apply, the industry itself would be driven forward by a freer, more populated market.
The changes would also inspire a more active, idea-laden atmosphere where the fear or rejection is minimized. Less work to apply means more applications, which equates to more devices and science on the cutting edge of medtech. And, in the end, this all sums up to more lives saved and improved through the wonder of technology.
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