Skip to main content

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 under FD&C Act § 506 Designation under FD&C Act § 515B.

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.

Official resources​

This change became effective on June 10, 2013, allowing manufacturers to petition for De Novo classification directly if their device is novel and does not have a suitable predicate for 510(k) comparison.