Every year medtech professionals look forward to the FDA Forum hosted by Medical Device Manufacturers Association (MDMA), Fogarty Innovation’s policy partner. This year, the two-day virtual event once again gave valuable insight to attendees on key regulatory issues and trends that will directly affect the regulatory and business strategies of companies of all sizes.
With more than 100 medtech professionals in attendance, the forum was kicked off by MDMA president and CEO Mark Leahey. Wide-ranging topics included getting the most out of pre-submissions, De Novo pathway updates, strategies to succeed during the review process, VALID Act updates, insight on navigating the 510(k) program and observations on digital health trends.
Speakers and panelists included Bill Brodbeck, STERIS Corporation; Heather Rosecrans, MDMA and Greenleaf Health; Marjorie Shuman, FDA; Anthony Piotrkowski, STERIS Corporation; Jamie Wilson, Stryker Spine; Daniel Schultz, Greenleaf Health; Craig Coombs, Coombs Medical Devices Consulting; and Chris Reed and Cassie Scherer, Medtronic; among many other industry and regulatory body experts.
Following are highlights of three particularly relevant topics from this informative conference: an update to the MDUFA agreement; tips for startups participating in the FDA review process; and insights into the digital health and data realm.
Update on the Medical Device User Fee and Modernization Act (MDUFA)
The FDA and industry recently reached an agreement in principal for a framework of a MDUFA reauthorization, which will determine how much funding the industry will provide for FDA product reviews from 2023 to 2027 and specify the performance goals the agency will be measured against.
MDMA, in partnership with AdvaMed and other industry trade organizations, worked to represent the industry’s interests to propose an efficient, effective and transparent process to help ensure new technologies are introduced to market in a timely manner. The framework will now be reviewed by Congress.
Strategies to succeed during the review process
While updates to the process to gain medical device approval are ongoing, best practices for success will remain the same. The panel shared wisdom from their own experience for companies undergoing the process. Here are select suggestions:
Create a clear regulatory strategy early on that defines the intended use of your device and therefore will point to the correct classification. This involves constantly interacting with your design and development team to incorporate existing guidance and understanding what testing is needed based on product risks.
The regulatory strategy document should take into consideration the entire product life cycle to prevent surprises later on and mitigate risk during submission by anticipating potential questions and how to address them. This document is also critical for the marketing team so they understand the indication for the product and their target market from the outset.
The FDA’s precept process can help validate what’s possible and what’s not in terms of your product development. Go into your pre-submission meeting with a well-designed plan and clear direction for your technology and R&D, rather than with open-ended questions.
Preparing your submission
To minimize time and resources, make sure to fill in the Refuse to Accept (RTA) checklist, which will speed the process and help the FDA reviewer by providing a roadmap of your submission.
Closely follow the FDA’s format, taking note of minor things like making sure pages are numbered correctly and all links work. If you deviate from the standard, make sure you provide the rationale.
When you find out who your reviewer is, reach out and introduce yourself, then leverage any opportunity to talk to them, such as making use of the FDA’s new 10-day call policy. Even if you don’t have specific questions, it provides an opportunity to get to know them, which can ease the process. Note any advice they offer, then follow up with an email so you have a written record and can keep track of details during the lengthy process.
Digital health trends and the questions around data security
Digital health has exploded with no end in sight. The forum’s discussion revolved around the current state and future of digital health as it relates to the FDA. Over the last few years, the organization has made efforts to create a more streamlined and efficient regulatory oversight to support software-driven innovation, evolve the medical advice framework and set up a structure that can handle new advances in AI innovation.
The good news is that the FDA plans to expand on these initial building blocks with the input of industry and other key stakeholders, with the ultimate aim of supporting an efficient approach for rapid iteration of AI-enabled technology, while maintaining transparency of the post-market performance. For example, the FDA has already created a pilot digital health software precertification (pre-cert) program designed to help identify best practices.
The FDA has also created a Digital Health Center of Excellence to provide training and strengthen partnerships with relevant organizations. One of the exciting aspects of this evolution is the FDA’s desire to address health equity via digital health technologies.
In addition, the organization has already authorized a few products through its predetermined change control plan, and it is actively hosting workshops on AI product transparency.
The FDA has a large role to fulfill as it tackles new ways to consider device risk and the impact data and machine-learned or deep learning algorithms will have on safety. There are also continuing questions about balancing privacy and value as medtech companies seek to access vast amounts of data to train AI. Databases have more than doubled in the past six years, and there will continue to be conversations about how to handle this valuable information.
With these and many other issues and questions to answer, security will continue to be a pressing and ever-evolving issue.