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dh239 replied to the topic Changes in FDA under Trump's Administration in the forum Regulatory Basics for Medical Devices 7 years, 6 months ago
The net effect of the increased user fees seems to be pointing to increased cost for small to mid-sized businesses in the medical device field and a greater burden on the end user of the device.
Small companies that produce potentially life-saving innovations already get bullied out of the marketplace due to a lack of the vast resources that larger corporations have. By increasing the burden on these businesses, the pace of development, especially through these avenues, would be hampered. Furthermore, the remodeling would not entirely remove the burden from American taxpayers but rather would funnel the burden into the industry itself, ultimately trickling down to those who need the devices. It would not be uncommon to see the increased costs be passed to only the American taxpayers that require treatment, and this would be a much greater burden because fewer individuals would be there to bear it.
There are benefits to this proposal, as have been outlined by my peers, but it is difficult to assess it as having more pros than cons when considering the needs of the patients and of the smaller businesses in the industry.