February 15, 2019
“Our mission to provide patients and health care providers with timely access to safe, high-quality medical devices includes conducting prompt, yet thorough, inspections of device manufacturing facilities. 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. “We’re publishing a draft guidance today that proposes a standardized process for providing this type of timely, efficient, and nonbinding feedback to manufacturers with respect to proposed corrective actions in response to our inspectional observations. 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.”
The FDA today issued a draft guidance titled Nonbinding Feedback After Certain FDA Inspections of Device Establishments, a requirement under the FDA Reauthorization Act of 2017 (FDARA). The draft guidance proposes a process by which companies can request from the FDA nonbinding feedback on certain kinds of documented inspectional observations that are issued on a Form 483, during either premarket or postmarket inspections of device establishments. It identifies a standardized method for communicating and submitting requests for nonbinding feedback and describes how the FDA evaluates and responds to such requests.
Previously, companies could ask for feedback on their proposed corrective actions, but there was no standardized process for providing nonbinding feedback. Timely nonbinding feedback can help device manufacturers determine whether proposed actions to address inspectional observations are adequate, possibly avoiding taking unnecessary actions that are not likely to satisfactorily address an inspectional observation.
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. Once a company files a request for feedback, the FDA intends to provide nonbinding feedback within 45 calendar days or notify the company within 45 calendar days that the request is not eligible to receive nonbinding feedback. The FDA’s feedback should identify whether the proposed actions to address inspectional observations, if appropriately implemented, appear adequate, partially adequate or inadequate.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.