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Medical device development relies heavily on standards to ensure patient safety, efficacy, and regulatory compliance. Organizations such as ASTM, AAMI/ISO, and USP establish critical test methods to ensure adequate cleaning and sterility, mechanical performance, biocompatibility, and material integrity. These standards streamline innovation while safeguarding patients, reducing redundant testing, and maintaining U.S. competitiveness in global markets.

The FDA’s Critical Role in Standards Development

For decades, FDA scientists and regulators have been active participants in shaping these medical device standards and often hold leadership roles on individual standards or committees. Their direct experience with reviewing ~20,000 medical device submissions per year renders their input invaluable on both the types of standards needed and the specific content needed within those standards. Because biomedical technology is advancing rapidly, particularly in design innovation and material selection, it is critical to patient safety that standards keep pace. Up-to-date standards not only protect patients but also benefit U.S. companies by streamlining the regulatory process. With well-defined, current standards, US manufacturers can focus on conducting only the studies necessary for patient safety, and avoid unnecessary, costly and time-consuming testing that would put them at a disadvantage in the global market.

Executive Order Freezes Communication and Participation in Standards Development

A chair of an AAMI working group announced last week that the FDA will be pulling away from communication and participation in standards development within AAMI and ISO as a result of a January 20, 2025 executive order from the White House. Other FDA scientists confirmed the freeze applies to all regulatory activities, including their ASTM participation. The freeze is not a permanent cessation of standard development activities, but no timeline has been given.

Risks of Reduced FDA Participation

Without FDA’s frontline regulatory experience, standards may lag behind medical device advancements, in areas such as AI-driven devices, nanotechnology, and biocompatible materials. Outdated standards could fail to address emerging risks, including cybersecurity vulnerabilities in connected devices or novel biomaterial interactions. U.S. manufacturers may face redundant testing to meet divergent global standards, increasing costs and time-to-market compared to international competitors.

Since the lack of FDA participation can put patients at risk, while also adversely affecting American medical device manufacturers, we sincerely hope that the new administration permits continued involvement of FDA personnel in the standards process.