Medical device manufacturers know that the FDA can inspect their establishment any time,
even without notice. There are four main reasons the FDA will inspect a device establishment: routine, “for cause,” pre-approval and compliance follow-up. When an FDA investigator observes any conditions which are in violation of the regulations, the firm will be issued a FDA Form 483. Firms are encouraged to respond to the 483 with their proposed corrective action plans and implement those plans immediately.
Responding to a 483 can be a nerve-racking process as the writer wants to ensure that the corrective actions will satisfy the FDA and put their establishment back into compliance (consider these 10 key elements when drafting a 483 response or contact us with any compliance questions).
Fortunately, the FDA is able to provide non-binding feedback on proposed actions to address certain observations cited on a 483 per section 702 of the FDA Reauthorization Act of 2017 (FDARA) (Public Law 115-52). This feedback could assist the firm in determining whether the actions proposed in a 483 response are adequate, thereby helping to avoid unnecessary investment in solutions that will not satisfy an inspectional observation. Recently, the FDA released a Guidance Document on submitting a request for nonbinding feedback.
Who: The request should be made by the person who received the 483 or the owner, operator or designated representative of the establishment.
What: The request should include the following information:
- The requester’s name, address, phone number, and e-mail address
- The establishment’s name, address, FDA Establishment Identification (FEI) number and the date(s) of the inspection
- A description of how one or more observations from the 483 “involves a public health priority,” “implicates systemic or major actions,” or “relates to emerging safety issues (as determined by [the FDA]).” Note that the FDA is only required to provide nonbinding feedback if one of these eligibility criteria are met.
- Details and a timeline of the proposed actions to the observation(s) identified in the 483 along with any supporting documentation
Where: The request should be sent to the same FDA contact who would receive the 483 response.
When: Submit the request within 15 days of receiving the 483.
How: Submit the request by mail or e-mail and include “Request for Nonbinding FDA Feedback After a Device Inspection” in the cover letter/subject line.
Within 45 days of receipt, the FDA will either deny the request or provide their non-binding feedback. Unless the FDA indicates that the proposed actions appear adequate, they will explain why the actions are partially adequate or inadequate and provide suggestions for improvement.
As the name suggests, establishments are not required to adhere to the FDA’s nonbinding feedback nor is there any guarantee that following the feedback will achieve compliance or prevent the FDA from issuing the same or additional observations.
Has non-binding feedback from the FDA helped you achieve compliance? Share your experiences below!Communication - Credit to https://www.semtrio.com/ via photopin (license)