Tuesday, June 3, 2014

New FDA Proposal to Expedite Approval Process for Medical Devices

At Mark-10 we’re always closely watching medical device trends and recently the FDA has proposed a new program to help speed up the approval process for devices that treat or diagnose patients with serious conditions whose needs aren’t met by current technology.

The new program would have more interactive engagement with FDA staff and unlike other existing programs, this one focuses on reducing the time associated with product development and not just reducing the time to market.

According to the FDA, to be eligible for participation, a medical device must:
“Be intended to treat or diagnose a life-threatening or irreversibly-debilitation disease or condition, represent one of the following:
1.       No approved alternative treatment/diagnostic exists, or
2.       A breakthrough technology that provides a clinically meaningful advantage over existing technology, or
3.       Offers a significant, clinically meaningful advantage over existing approved alternatives, or
4.       Availability is in the patient’s best interest
And have an acceptable data development plan that has been approved by the FDA.”

At Mark-10, we’re happy to play a helping role for medical device manufacturers to meet their quality objectives. Our line of force and torque measurement systems may be used for numerous applications, including fastener torque, needle sharpness, catheter torque, tube terminal pull tests, peel testing, tensile testing, and more. Visit our website to learn more.