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Medical technology manufacturers and FDA share a common goal: To ensure patients have timely, access safe and effective medical devices and diagnostics. To achieve that shared goal, manufacturers and FDA must have clear, well-understood regulatory requirements and open lines of communication.
As the regulator, FDA sets the rules of the road; they are responsible for developing regulations and explaining through guidance and other communications how it expects manufacturers to meet those regulations. But the agency does not have a monopoly on expertise, especially when considering the vast array of medical technologies. That is why the agency must have an open dialogue with medtech manufacturers and other stakeholders to benefit from their expertise to ensure any requirement makes sense, is achievable and will not inadvertently stifle innovation.
For their part, medical technology manufacturers need clear and unambiguous requirements from the agency. The challenge of bringing new innovations to patients would be impossible if the goal posts for compliance kept moving.
Both FDA and medtech companies have their responsibilities to bring safe and effective products to market, and it requires meaningful interaction. It’s a constant learning process that hinges on open communication. It’s working together to achieve what works for both.
While there is always a healthy tension between regulators and the regulated, taking an adversarial approach to compliance is not productive. Dr. Alpert offers a helpful analogy.
She says, “You don’t get people to follow the speed limit by stopping everybody. You teach them when they take drivers’ ed, you post the speed limits, and then you catch the people who are not complying. That’s a smart regulatory approach.”
Get more insight from Dr. Alpert in the video below. Learn more about FDA’s interactions with manufacturers and other health care stakeholders.
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