The View from Washington: What Device Makers Need to Know about FDA’s Latest Strategic Priorities and Initiatives

• Posted in Legal, Clinical & Regulatory | August 31, 2011 | Comments (0)
• Tags: fda, supplier, supply chain, regulatory, omtec, product development
• By: Martin Browning

Agency Announces Five Key Priorities over Next Five Years

Continuously hammered by Congress, news media and the international health community, the U.S. FDA has responded with a five-year plan that could have far-reaching consequences for the medical device industry.

In late April 2011, FDA Commissioner Margaret Hamburg and her staff released a 50-page report on FDA’s Strategic Priorities, 2011-2015: Responding to the Public Health Challenges of the 21st Century. The report outlines five goals and accompanying actions that cut across all types of FDA-regulated products. In addition, the report sets two more goals specifically targeting the medical device industry.

FDA’s five cross-cutting priorities over the next five years include:

1. Advance regulatory science and innovation
2. Strengthen the safety and integrity of the global supply chain
3. Strengthen compliance and enforcement activities to support public health
4. Address the unmet public health needs of special populations, and
5. Advance medical countermeasures and emergency preparedness

The theme running throughout the entire strategic plan is the agency’s renewed focus on regulatory science and innovation. “Science underlies everything we do at this agency, and to serve the public health we must have the capacity to effectively oversee the translation of breakthrough discoveries in science into innovative, safe and effective products and life-saving therapies for the people who need them most,” the Commissioner says.

Let’s examine where these priorities intersect the interests of the device industry.