FDA recently announced its new Safer Technologies Program (STeP), which intends to make medical devices and combination devices eligible through the Breakthrough Devices Program (BDP).
Requirements for eligible devices include those that significantly improve the safety of currently available treatments or diagnostics for underlying diseases or conditions associated with less serious morbidities and mortalities.
Today’s guest is Mike Drues of Vascular Sciences, who joins Jon Speer to discuss how this new program may be applicable to your medical device and design efforts.
“Neither the STeP, nor the BDP is a pathway to market.”
“The STeP and the BDP are separate and distinct animals. If you get BDP designation, you are not eligible for STeP, or vice versa.”
“Regulation is all about the interpretation of words and our ability to defend our interpretation.”
“Like the BDP, STeP doesn’t say anything about prevention of diseases, injuries, or conditions. They only talk about treatment or diagnosis. This is a huge concern.”
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Nick Tippmann is the Chief Marketing Officer for Greenlight Guru, a MedTech Lifecycle Excellence Platform (MLE) that provides an industry-specific solution to help medical technology innovators around the world use quality as an accelerator to move beyond baseline compliance and achieve True Quality. Tippmann is...