On August 18th, President Trump signed the FDA Reauthorization Act (FDARA). Besides reauthorizing user fees for pharmaceuticals and medical devices for five years the law also focuses on many aspects of device regulation.
One of the focuses on the law is to improve efficiency and reliability when it comes to inspections. Under the new FDARA the FDA must adhere to a risk-based medical device inspection schedule. The schedule will be based on several factors: compliance history, the nature of the device, past inspection history, and whether the organization utilizes an internal audit system.
As mentioned above, one of the goals of this law is for the FDA to run more efficiently. One of the ways they must do this is through improved transparency. Past industry concerns have been that the FDA has at times been unpredictable and not always been clear with reasons for their decisions. As a result the FDA now must make the timing of their inspections more predictable, and more importantly open lines of communication to expedite the resolution of inspection finding.
This last directive in the FDARA should not be understated. The ability for medical device organizations to ask for informal feedback can ease the burden of taking on costly corrective measures with no real guidance from the FDA that their fix will actually address the problem. In fact the FDA must respond to a request for non-binding feedback within 45 days if the issues they singled out involved a public health priority, emerging safety issue, or would be a major systemic undertaking by the device organization.
In short, the changes that the FDARA are making can be beneficial to device manufactures, but only if they take advantage of them. By proactively opening communication with the FDA during all phases of inspection the likelihood that extensive corrective measures will be needed should be reduced.
Criterion Edge is a regulatory writing company that provides outsourced writing services to the pharmaceutical and medical device industries. The company’s expertise in regulatory writing best practices, honed over decades, produces superior deliverables and provides budget, resource and timeline flexibility for regulatory managers. Criterion Edge empowers companies to deliver superior health care solutions. To learn more about how Criterion Edge can help you achieve your regulatory goals, click here to contact us, call us at 805-202-5520, or use the email: email@example.com.
June 17-21, 2019
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