In addition to re-evaluating its pharmacotherapeutic review process against the backdrop of reform, the FDA is proposing changes to its medical device review process. Essentially, it’s focusing on the scheme in which medical device makers have to prove their product is similar to one already in the marketplace before launching it commercially. This proposal may be in response to critics of the present process, which bypasses clinical trial rigor — potentially releasing an unsafe device to public. Other points the FDA is considering:

• Making the approval process smoother for so-called medical devices brand-new to the market (novel), as those would not be similar to a product currently on the market but are still relatively low-risk.
• Issuing guidelines on when a device on the market shouldn’t be used as the basis for approval of a new device; so that approvals cannot be based on an unsafe product.
• Issuing alerts/bulletins to medical device makers to better communicate changes in preapproval expectations.

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