Requesting Nonbinding Feedback on Form FDA 483 Inspectional Observations
This guidance explains how device establishment owners can request nonbinding feedback from FDA regarding their proposed actions to address certain inspectional observations documented on Form FDA 483. It outlines the submission process, eligibility criteria, and FDA's evaluation and response procedures.
What You Need to Know? 👇
What is the purpose of FDA’s nonbinding feedback after device inspections?
The nonbinding feedback helps device firms determine whether their proposed corrective actions adequately address FDA 483 observations, potentially avoiding unnecessary investment in solutions that may not satisfactorily resolve inspectional findings.
Who is eligible to request nonbinding feedback after an FDA device inspection?
The owner, operator, or agent in charge of the device establishment, or their designated representative, can request nonbinding feedback. The request must come from the person who received the FDA 483 form.
What are the statutory eligibility criteria for receiving nonbinding feedback?
Observations must involve a public health priority, implicate systemic or major actions, or relate to emerging safety issues. These typically involve conditions that could result in violative products causing death or serious injury.
How quickly must a request for nonbinding feedback be submitted after an FDA inspection?
Requests must be submitted within 15 business days after issuance of the FDA 483 form to be considered timely. Late requests may not qualify for the statutory nonbinding feedback process.
How long does FDA have to provide nonbinding feedback once a request is received?
FDA must provide nonbinding feedback within 45 calendar days of receiving a timely, eligible request. If the request doesn’t meet eligibility criteria, FDA will notify the requestor within the same timeframe.
Does implementing FDA’s nonbinding feedback guarantee compliance or prevent future regulatory action?
No. FDA’s nonbinding feedback doesn’t guarantee adequacy, prevent future citations, or limit FDA’s regulatory options. Firms remain responsible for ensuring compliance with applicable laws and regulations regardless of feedback received.
What You Need to Do 👇
Recommended Actions
- Review Form FDA 483 observations to determine if they meet eligibility criteria (public health priority, systemic issues, or emerging safety concerns)
- Prepare request package within 15 business days including:
- Clear identification as feedback request
- Contact information and establishment details
- Detailed justification for eligibility
- Comprehensive corrective action plan with timeline
- Supporting documentation
- Submit request to designated FDA contact provided during inspection
- If feedback received, evaluate FDA’s recommendations for:
- Adequacy of proposed actions
- Additional measures needed
- Implementation planning
- Document implementation of corrective actions, whether following FDA feedback or alternative approach
- Maintain awareness that implementing FDA’s feedback does not guarantee compliance or prevent future regulatory action
Key Considerations
Safety
- Observations must involve public health priority that could result in release of violative products causing death or serious injury
- Observations must relate to emerging safety issues that could result in devices likely to cause death or serious injury
- Systemic or major deficiencies must be addressed to prevent release of nonconforming devices that pose serious public health risks
Other considerations
- Request must be submitted within 15 business days after Form FDA 483 issuance
- Request must come from owner, operator, agent in charge or designated representative
- Request must include clear identification as “Request for Nonbinding FDA Feedback After a Device Inspection”
- Detailed justification explaining how observations meet eligibility criteria must be provided
- Proposed corrective actions with timeline and supporting documentation must be included
- FDA will respond within 45 calendar days if request meets eligibility criteria