Special Pathways for Innovative Devices: A Guide to the FDA’s Breakthrough Device and Safer Technologies Programs
The FDA is practically begging devicemakers to explore innovative methods and technologies to address serious and unmet medical needs. So much so, it’s willing to help you do just that with its special review pathways: Breakthrough Device Program and Safer Technologies Program (STeP).
The Special Pathways for Innovative Devices: A Guide to the FDA’s Breakthrough Device and Safer Technologies Programs management report takes you through the process every step of the way.
While both programs offer additional agency consultation and priority review status, each differs in its approach to device innovation. If you’re at all unclear on the specific criteria, intricacies of the submission process and detailed benefits, you’re missing out.
Special Pathways for Innovative Devices clarifies the ins and outs of the Breakthrough Device Program’s focus on development of new and unique treatments for life-threatening or irreversibly debilitating diseases. The report contrasts this with STeP, which is designed to promote methods and technologies that have the potential to significantly improve the safety of treatments for less-serious diseases.
The report also includes information on reimbursement considerations for program-approved devices and how reimbursement may change in the near future.
If you’re looking for successful applications in the Breakthrough Device and STeP programs, this report is the answer.
- Eligibility requirements for both programs
- Timing and content of submissions
- Review process
- Unique handling for combination products
- Reasons for withdrawal of breakthrough device designation
- Outlook for reimbursement for digital health products
- Impending repeal of the Medicare Coverage of Innovative Technology (MCIT) rule and its impact on breakthrough devices
Getting a breakthrough or STeP designation can propel your device to success. This success begins with Special Pathways for Innovative Devices: A Guide to the FDA’s Breakthrough Device and Safer Technologies Programs.
About the Contributors
Kristin Davenport, of counsel at Covington & Burling, advises medical device companies regarding premarket strategies and pathways, the premarket submission process, advertising and promotion, compliance and enforcement matters, and import/export issues. She has extensive experience with 510(k) premarket notifications, de novo petitions, premarket approval applications, investigational device exemptions, device modifications, 513(g) Requests for Information, MDR reporting, device recalls and Part 806 reports.
Rujul Desai, of counsel at Covington & Burling, advises clients on drug pricing, market access, reimbursement, strategic contracting and regulatory solutions for drugs, biologics, devices and diagnostics. He brings deep experience with biopharma, specialty pharmacy and pharmacy benefit management (PBM) companies. Desai has held a number of leadership roles in the biopharma, PBM and specialty pharmacy industry, including with CVS Caremark, UCB and most recently as vice president at Avalere Health.
Who Will Benefit
- Regulatory, quality and compliance specialists
- Device design teams
- Software developers
Add to Cart
Kristin Davenport and Rujul Desai
Save money with a license agreement allowing significant numbers of users access to an electronic version of this book. For multi-user access to multiple titles, FDAnews offers the FDAnews Books Library — a personalized collection of FDAnews publications that is fully searchable. Contact Customer Service for a quote or more information.
Not satisfied with your publication? For the PDF version, you must notify FDAnews within 24 hours of receipt of purchase and we will refund 100 percent of your purchase price.