21st Century Cures Act — Device Provisions
The 21st Century Cures Act (Public Law 114-255), signed December 13, 2016, is the most significant legislation affecting FDA device regulation since FDASIA (2012). Its device provisions reshaped how FDA regulates software, digital health, and innovative devices.
Breakthrough Device Designation
The Act created the Breakthrough Device Designation program by adding FD&C Act § 515B. This programme provides:
- Priority review for devices that provide more effective treatment or diagnosis of serious or life-threatening conditions
- Enhanced FDA-manufacturer interaction during development
- Organisational commitment — senior FDA staff assigned to the review
- No lower regulatory standard — the device must still meet the applicable SE or safety/effectiveness threshold
This replaced and improved on the earlier "Expedited Access Pathway" pilot.
Software exclusions — FD&C Act § 520(o)
One of the most impactful device provisions, § 520(o) excludes certain software functions from the definition of a device:
| Excluded software function | Description |
|---|---|
| Administrative support software | Scheduling, billing, claims processing |
| General wellness | Functions for maintaining a healthy lifestyle that present a low risk |
| Electronic patient records (EHR/EMR) | Clinical EHR functions not intended for diagnosis/treatment |
| Transferring, storing, displaying data | Software that transfers data without analysing or interpreting it |
| Certain clinical decision support (CDS) | CDS that is not the primary basis for a clinical decision and for which the basis for recommendation can be independently reviewed |
The CDS exclusion in particular has been the subject of extensive FDA guidance (finalised in 2022) — determining whether software falls within or outside the exclusion is one of the most contested questions in US digital health regulation.
Predetermined Change Control Plans (PCCPs)
The Act directed FDA to establish a framework for Predetermined Change Control Plans — pre-specified plans submitted with a device's premarket submission that describe anticipated future modifications and the methods to evaluate those changes. FDA finalised PCCP guidance in 2024. This is particularly important for AI/ML-based SaMD.
HDE and humanitarian device reforms
The Act made additional modifications to the Humanitarian Device Exemption:
- Further clarified the profit restriction exemption for paediatric devices
- Directed FDA to streamline the HUD designation and HDE approval process