The STeP Program is not the result of legislative activity and will require buy-in from the FDA and industry. An important difference between the STeP Program and the Breakthrough Devices program is legislative support. The Breakthrough Devices Program was enacted by the 21st Century Cures Act and amended by the FDA Reauthorization Act of 2016. In this respect, the Breakthrough Devices Program benefits from its legislative support and the governmental resources committed to its success. This provides the accountability necessary to help ensure the promises of the Breakthrough Devices Program are met, allowing industry to have more confidence using this program.Read More
In this third installment of our three-part series, we cover some anonymous but real-world examples of Pre-Sub issues we have encountered in 2019 and 2020. We discuss FDA’s inability to compromise on data that are necessary and Least Burdensome for a submission unless the studies are 100% of their own making—defeating the very purpose behind the Pre-Sub. We call it “It’s my way or the highway.” We also cover when they have backtracked on deals struck in Pre-Sub discussion—again defeating the very purpose behind the Pre-Sub. We call it “When the review team acts like Lucy and pulls up the football at the last second and Charlie Brown misses.” And among a few other smaller topics, how they unfairly edit meeting minutes to reflect points or matters not stated or discussed—again defeating the very purpose behind the Pre-Sub. We call it “He said, she said.” We conclude with key areas for FDA to fix.Read More
In this second installment of our three-part series, we cover the more technical aspects and strategies behind a Pre-Sub. In this installment we review the decision of whether to have a Pre-Sub or not, how to persuade FDA to your position in writing a Pre-Sub request, and some preliminary thoughts about how to prepare for a Pre-Sub.Read More
Join us as we begin a new series on our experiences with FDA's Pre-Sumission process. In this first installment, we focus on the idea behind this series of Client Alerts.
To explore the strange world of FDA Pre-Submission meetings we use the metaphor of the Addams Family—the popular 1960's TV comedy. You remember the characters—the patriarch and matriarch, Gomez and Morticia, who play the Office and Division Directors at FDA who in their running of the household are completely unaware that their family just doesn't fit into the real world, that people are afraid of their ways, and don't understand their intentions---which are often out of sync with the world outside their home.Read More
The medical device industry is ever-evolving. Our experts weigh in on what they expect to see from industry in the new year in this Client Alert. With each of our specialists commenting on their specific areas of expertise, this is a Client Alert that shouldn't be overlooked by anyone engaged in regulatory affairs.
Continue reading to see what each of our in-house regulatory affairs experts expect to see in 2019, within their particular disciplines..Read More