Medical Device Premarket Review Pathways and FDA Mechanisms for Expedited Review – Webinar Recording/Transcript
Finding a successful premarket pathway for your medical device can bring effective, crucial treatments to patients at a quicker speed, saving lives and improving symptoms. There are multiple ways to gain a faster review — or reach a customer base within an expedited time frame — but none of them are without complexity.
Do you have a device that you’re considering pushing forward to the market at a faster than typical speed? Have you been trying to better understand the Breakthrough Designation process or the recent Safer Technologies Program for Medical Devices (STeP)? Is your team interested in learning more about 510(k), de novo or PMA pathways?
The Medical Device Premarket Review Pathways and FDA Mechanisms for Expedited Review presentation will detail the avenues that you can take to achieve a successful premarket review from the FDA. Legal and regulatory experts Kristin Davenport, Rujul Desai and Christina Kuhn will share insights into the final guidance from the FDA around the STeP program and how navigating the eligibility criteria and submission requirements differ from those necessary to obtain a Breakthrough Designation. They’ll also discuss specific questions around situations that could arise for an organization jumping into this process, like what to do with two devices that have the same intended use. Finally, they’ll share their thoughts on the current state of the Medical Coverage of Innovative Technology (MCIT) Pathway.
- FDA Premarket Review Pathways
- Best practices for interacting with the FDA
- Criteria and processes for various pathways
- Submission timing and content requirements for obtaining a designation
- Eligibility for designation for specific situations, including two devices with the same intended use or combination considerations
- Breakthrough Device Designation and STeP
- Criteria for Breakthrough Device Designation
- Submission timing and content requirements
- Benefits of breakthrough designation or STeP program inclusion
- Medical Coverage of Innovative Technology (MCIT) Pathway
- Updates on the current MCIT program status
- CMS’ final rule on coverage, repeal of that rule and concerns around the original provisions and plans
- MCIT connections to the upcoming 21st Century Cures Act
Order today for insights into which process is best for you and how you can find success at the end of the journey.
Meet Your Presenters
Kristin Davenport, of counsel at Covington & Burling LLP, 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. Ms. Davenport regularly prepares 513(g) requests for information to obtain FDA’s views regarding the classification and applicable regulatory requirements for novel devices, such as mobile medical applications. She develops successful premarket strategies for clients and frequently participates in pre-submission meetings with CDRH. She navigates issues that arise during the premarket review process and has successfully represented device companies in administrative appeals.
Rujul Desai, of counsel at Covington & Burling LLP, advises clients on drug pricing, market access, reimbursement, strategic contracting and regulatory solutions for drugs, biologicals, devices and diagnostics. He brings deep experience with biopharma, specialty pharmacy and pharmacy benefit management (PBM) companies. Mr. 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. He has led engagements across a wide range of U.S. and global market access and reimbursement issues, including optimizing new product launches, pricing, PBM and payer formulary access, value-based contracting, distribution network design, patient access and hub services, affordability programs, e-prescribing, digital health and the use of health economic data and modeling.
Christina Kuhn is an associate at Covington & Burling LLP and advises medical device, pharmaceutical, and biotech companies on a broad range of FDA regulatory strategy and compliance matters. She has experience with cutting-edge and complex medical technologies, including software and digital health products, oncology products, next-generation sequencing, diagnostics, and combination products. Ms. Kuhn frequently helps multinational device manufacturers, as well as start-up device companies, navigate the premarket regulatory process, advising companies on regulatory classification, clinical development strategy, and agency interactions. She also has significant experience counseling medical device companies on postmarket compliance requirements.
Who Will Benefit
- Medical device companies
- Digital health companies
- Regulatory affairs specialists
- Compliance specialists
- Quality specialists
- QSR staff
- Inspections and audit team members
- Postmarket safety professionals
- Submissions and approvals staff
- Research and development team members
- Commercial operations staff
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Jan. 12, 2022