FDARA Signed into Law

On August 18, 2017 the President signed FDARA into law. The Act may be cited as the FDA Reauthorization Act of 2017.

For device manufacturers, Title II is Fees Relating to Devices. It sets the user fees for the next few years.

In addition, Title VII is entitled Device Inspection and Regulatory Improvements. The title has the following sections.

Sec. 701 Risk-based inspections for devices
Sec. 702 Improvements to inspections process for device establishments
Sec. 703 Reauthorization of inspection program
Sec. 704 Certificates to foreign governments for devices
Sec. 705 Facilitating international harmonization
Sec. 706 Fostering innovation in medical imaging
Sec. 707 Risk-based classification of accessories
Sec. 708 Device pilot projects
Sec. 709 Regulation of over-the-counter hearing aids
Sec. 710 Report on servicing of devices