The FDA Safety and Innovation Act was signed into law this past week by President Obama. This important legislation will impact the medical device industry – and the medical community at large – in a number of different ways, and representatives of groups such as Biocom, CONNECT, and the West Wireless Health Institute had an important hand in guiding the Act to its final draft.
One of the key aspects of the FDA Safety and Innovation Act is the extension of the user fee program, which will see medical device companies paying just under $600 million in fees during the course of the five calendar years that the Act is in effect. These fees are intended to help offset the costs of the FDA’s plans to simplify, streamline, and otherwise improve a wide range of different aspects of the current regulatory path to market for devices.
On the schedule are a re-think of the current de novo process that removes the requirement to file a 510(k) premarket notification, a change in how device modifications affect the requirement to submit a new 510(k) application, and a number of amendments to IDE approval standards, especially from a reviewer’s perspective. Post-market scrutiny will be also be enhanced on the FDA side with regard to medical devices, with recall trend monitoring, additional audit checks, and the new ability to issue an administrative order reclassifying a low-risk product as a Class III device if post-market data supports the decision.
The FDA Safety and Innovation Act is part of the continuing trend at the Administration to improve transparency and communication between stakeholders in moving a medical device to market. The Act also attempts to ease some of the strain felt by companies that have experienced delays in reclassification, appeals, and regulatory approval over the course of the past 10 years as the FDA has been overwhelmed by the number of 510(k) applications streaming through its doors.
- Subscribe to our blog to stay informed on industry news and insight.
- Contact us to learn more about this topic, or medical device clinical trials or adaptive clinical trials overall.
- Watch our latest videos, webinars, and whitepapers covering adaptive design execution and benefits, medical device requirements on the FDA 510(k) process, and much more.
Aptiv Solutions Blogging Team