FDA Safety and Innovation Act (FDASIA)
The FDA Safety and Innovation Act (FDASIA), signed into law on July 9, 2012 (Public Law 112-144), made significant changes to the FDA medical device regulatory framework. It is the most significant device legislation since the Medical Device Amendments of 1976.
Key medical device provisions
De Novo as a standalone pathway
Prior to FDASIA, De Novo classification was only available after receiving a Not Substantially Equivalent (NSE) determination on a 510(k). FDASIA amended FD&C Act § 513(f)(2) to allow manufacturers to submit a De Novo classification request directly — without first filing a 510(k) and receiving an NSE. This made De Novo a true standalone pathway for novel, low-to-moderate risk devices.
MDUFA III (Medical Device User Fee Amendments III)
FDASIA reauthorised the Medical Device User Fee program under MDUFA III (covering FY2013–FY2017), establishing:
- User fees for 510(k), PMA, De Novo, and PMA supplement submissions
- Performance goals for FDA review timelines
- Provisions for small business fee reductions
- Enhanced transparency and reporting requirements
Unique Device Identification (UDI) mandate
FDASIA added FD&C Act § 519(f), directing FDA to establish a unique device identification system. This led directly to FDA's UDI final rule (21 CFR Part 830) issued in September 2013, requiring device labellers to include a unique device identifier on device labels.
Humanitarian Device Exemption (HDE) reform
FDASIA modified the HDE pathway:
- Increased the patient population threshold from 4,000 to 8,000 individuals per year in the USA
- Removed the profit restriction for paediatric devices — HDE holders may generate profit on paediatric HDE devices without IRB approval
Breakthrough therapies and priority review
FDASIA established the Breakthrough Therapy Designation for drugs — a concept later extended to devices through the 21st Century Cures Act (2016) as the Breakthrough Device Designation.
Third-party 510(k) review expansion
FDASIA expanded the accredited persons program (third-party 510(k) review) to include a broader range of Class II device types, allowing FDA-accredited third parties to review certain 510(k) submissions and make SE recommendations to FDA.
Interoperability and health IT
FDASIA directed FDA, ONC, and FCC to produce a report on the regulation of health information technology — an early step toward the current digital health and SaMD regulatory framework.