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FDA Announces Changes to 510(k) Process

The last several years have brought many changes to the medical device quality and regulatory industries, and recent FDA announcements promise even more in the near future. As announced in late November 2018, there are significant updates planned for the 510(k) submission process, specifically related to the use of predicates. 

In keeping with industry trends, a major factor cited for the upcoming changes was an emphasis on the risk-based

In recent years, patient care has swiftly advanced as manufacturers used predicates to quickly move greatly needed devices to market. However, as technology rapidly advanced in the last decade, an increasing number of intricate devices have used outdated devices as predicates. In some of cases, the predicates used have not even been on the market for many years. Advancing medical devices to the market without properly vetting them places consumers at increased risk, which has been a driving factor of the change. As FDA Commissioner Scott Gottlieb explained in an interview with CNBC, “What we want to do is constantly push the market toward incorporating better technology and better capabilities by advancing the predicates and always looking forward so the . . . predicates the device companies are using as the basis of their approvals are constantly incorporating newer and better technology to make the devices better and safer.”

This latest announcement follows several other changes announced by the FDA in recent years, including the adoption of MDSAP, increased expectations for post-market surveillance, and the planned adoption of ISO 13485 as the foundation for quality system legislation. If your company is struggling to navigate the rapid changes occurring in the industry, Medpoint can help. Our consultants have the experience necessary to successfully help you remain compliant, achieve compliance, and bring new devices successfully to market. To learn more, contact us today at or 800-200-9292.

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