FDA has issued draft guidance providing for more timely nonbinding feedback following medtech facility inspections to advise whether the companies’ proposed corrective actions appear adequate to the agency.
The draft guidance proposes a process by which companies can request nonbinding feedback on certain kinds of observations issued on a Form 483. It outlines a standardized method for companies to request nonbinding feedback and describes how the agency evaluates and responds to such requests.
FDA said it will try to provide feedback within 45 calendar days to say whether the company’s proposed corrective actions appear adequate, partially adequate or inadequate. Previously, companies could ask for such feedback, but FDA had no standardized process for providing it. Timely nonbinding feedback may help device manufacturers avoid taking actions that are unlikely to satisfactorily address a problem flagged by inspectors, according to the agency.
A request for nonbinding feedback must describe how one or more observations meet one or more of the statutory criteria: involve a public health priority, implicate systemic or major actions, or relate to emerging safety issues.
“When device firms have questions about our inspectional observations, it’s important for communications between the agency and manufacturers to be clear and efficient so companies can address safety and quality issues as quickly and as adequately as possible to help them come into compliance with our regulations,” said Jeff Shuren, M.D., director of the Center for Radiological Devices and Health, in a prepared statement. “Providing companies with earlier feedback can help us fulfill an important part of our work to ensure FDA-regulated devices meet our rigorous expectations for quality, safety and effectiveness.”
|
Tell Us What You Think!