On Feb. 13, 2018, FDA Commissioner Scott Gottlieb, MD, released the FDA's budget request, which includes about $400 million in additional funding to support the development of medical technology and devices.
Here are the FDA's eight planned initiatives:
1. Promote domestic manufacturing by developing efficient regulatory pathways for modern drug and biological product manufacturing technologies. Through science-based regulation, the FDA aims to help reduce the cost and uncertainty of adopting these new manufacturing platforms.
2. Create a Center of Excellence on Compounding for Outsourcing Facilities, which would identify and propose solutions to market barriers preventing pharmacies from becoming outsourcing facilities.
3. Establish a voluntary certification program for device manufacturers. The FDA would recognize third-party certifiers and offer regulatory incentives to achieve certification, increasing competition and device quality.
4. Use clinical data to better inform product review. The FDA will establish a new capability to conduct near-real-time evidence evaluation down to the level of individual EHRs for at least 10 million individuals in a range of healthcare settings in the U.S.
5. Allow companies to market lower-risk digital health technologies without FDA premarket review and market higher-risk digital health technologies after a streamlined FDA premarket review if the company receives a prior third-party certification. The FDA plans to create a Center of Excellence on Digital Health to facilitate this, the regulatory build new capacity to evaluate and recognize third-party certifiers and support a cybersecurity unit to complement the advances in software-based devices.
6. Build a knowledge management system and portal to existing and evolving information on drug development. The system would also be connected to previous regulatory decisions.
7. Develop clinical trial networks to encourage investment in and innovation of products targeted to rare diseases.
8. Create a new review platform that would shift generic drug review from a text-based to a data-based assessment with structured submissions and FDA assessments. This would also support efforts to update generic drug labeling and encourage wider adoption of generic medicines.
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