FDA simplifies process for novel medical devices

Truly innovative devices that do not have a “substantially equivalent” predecessor are automatically lumped into Class III, reserved for high-risk devices, and need a costly clinical trial to gain approval. But not all new products are high risk. To fix this barrier to innovation, FDA created the de novo approval pathway in 1997, enabling applicants to apply for approval as low- or moderate-risk devices.

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The Sunshine Act: Promising Clarity & Providing Confusion

The logic behind the Sunshine Act says that providing clarity on any money that pharma and device makers pay to doctors and hospitals will reduce the occurrence or appearance of corruption. .

The idea is that by making those payments a matter of public record makes it undesirable for companies to try to influence medical experts.

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