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US FDA Launching New Premarket Approval (PMA) Pilot Program for High-risk Medical Devices

The FDA are currently setting up a pilot programme on several high risk medical devices, they hope that the outcome of this programme will allow them to have a more efficient PMA process.

Currently the authority is searching for nine applicants who will be enrolled from the end of September 2017 to Dec 2018, as soon as nine suitable applications are accepted the pilot will begin. It has been noted that the FDA are focusing on the quality issues of the pre-market process in order to drive down high-risk device recalls, with the ultimate goal to streamline the complex and expensive PMA process without compromising controls for safety and effectiveness of devices.

This initiative could lead to less costly and time-consuming PMA requirements for manufacturers of high-risk devices.

Here at Instem we understand that the PMA process can be long, costly and error prone. We hope that this pilot is successful and our customers can get their products to market more efficiently.

If you wanted to speak to any of our experts about Medical Device submissions or to view our solutions that will help bring your life enhancing products to market faster please reach out to us.

Speak to our team via email [email protected] or call us on +44 1244 287 900.



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