- FDA is launching an effort to improve communications with medical device companies by establishing a process for giving nonbinding feedback on corrective actions stemming from inspection observations.
- In a draft guidance, FDA said the process will standardize how it will evaluate and respond to requests for feedback about observations documented on a Form 483 during premarket and postmarket inspections of device establishments.
- Once a company files a request for nonbinding feedback, FDA intends to provide its response within 45 calendar days or notify the company within that time if the request is not eligible for the feedback.
Companies have always been able to ask for nonbinding feedback on the corrective actions they propose in response to FDA’s inspection observations. No standard channel has existed, however, for FDA to offer nonbinding advice.
The new process is intended to streamline the agency's responses so companies can address safety and quality issues as quickly and adequately as possible, Jeff Shuren, director of the Center for Radiological Devices and Health, said in a press release. The process should help device manufacturers avoid taking unnecessary actions that are unlikely to address the agency’s observations, according to FDA.
"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," device center chief Jeff Shuren said in a statement.
A request for nonbinding feedback should be submitted within 15 business days after a Form 483 is issued. If a company is also submitting a response to the Form 483, the agency recommends both be included in the same submission but as two distinct documents.
A company should include a detailed description, timeline and supporting documents for the actions it plans to take to correct the conditions described in FDA's observations and prevent a recurrence. The request must: describe how the observation meets statutory criteria, involve a public health priority, implicate systemic or major actions, or relate to emerging safety issues, according to the draft guidance.
FDA said its feedback should identify whether a company's proposed actions to address inspection observations appear adequate, partially adequate or inadequate. The agency also said it will provide a recommendation on what may be needed for the proposed actions to be considered adequate.