, 4 tweets, 1 min read Read on Twitter
THREAD: We announced two more steps in efforts to modernize FDA’s 510(k) path for medical devices. go.usa.gov/xEZwe 510(k) devices coming to market should account for advances in technology that improve safety or performance or meet modern safety and performance criteria.
Our final guidance issued today establishes an approach whereby manufacturers of certain devices may be able to demonstrate that their products meet objective safety and performance criteria that are based on modern technological principles.
We’re also seeking comment on steps we could take to further encourage development of innovations that enhance the safety of 510(k) devices, including whether we should post a list of #FDA-cleared devices that demonstrated substantial equivalence to older predicate devices.
We believe these steps would create more transparency about these technologies, with the goal of driving device manufacturers to offer patients devices with the latest improvements. We look forward to reviewing feedback on these approaches.
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