Inside FDA’s Latest CDRH Annual Report: Trends Device Manufacturers Should Watch
FDA’s Center for Devices and Radiological Health (CDRH) uses its Annual Report to signal where it is spending its budget and attention. The 2024 report isn't just a retrospective; it is a forward-looking roadmap emphasizing novel authorizations, the "Home as a Health Care Hub" initiative, and a relentless focus on digital health and cybersecurity.
For small and mid-sized manufacturers, these high-level themes translate into concrete regulatory risks. The report highlights continued growth in novel device authorizations (De Novo and PMA), suggesting that FDA is becoming more comfortable with advanced technologies—provided the evidence is robust. However, it also signals that the agency is modernizing its post-market surveillance tools (MAUDE, active surveillance), meaning they are getting faster at detecting signals when products fail in the field.
The Shift to the Home & Cyber-Safety
Two specific priorities stand out: "Home as a Health Care Hub" and Cybersecurity. FDA is actively encouraging devices that move care out of the hospital, but this comes with stricter scrutiny on usability, labeling, and lay-user safety. If your device is listed under a professional-use product code but marketed for home use, you are creating a compliance mismatch that FDA is now primed to spot.
Similarly, cybersecurity is no longer an IT issue; it is a safety issue. The report underscores that "designing security in" is mandatory. If your device listings include software-enabled product codes but your design history file lacks a robust cybersecurity architecture, you are exposed during your next inspection or pre-market submission.
Aligning Your Strategy with CDRH Priorities
BRS LLC helps you translate these federal priorities into a defensible regulatory strategy:
- Product Code Hygiene: We review your device listings to ensure your Product Codes and Regulation Numbers accurately reflect your technology (e.g., software-enabled vs. hardware-only), preventing delays at Customs.
- Home Use Alignment: We help assess if your current registration data and labeling support a "Home Use" claim or if you need to adjust your regulatory filing.
- Pathway Advisory: We provide executive guidance on whether your novel technology fits a 510(k) or requires a De Novo strategy, aligning with CDRH's push for innovation.
- Post-Market Vigilance: We help set up U.S. Agent workflows that ensure you catch FDA safety signals early, rather than waiting for a Warning Letter.
Our goal is to help you align with where CDRH is heading, not just where it has been. Don't let legacy data hold back your modern portfolio.