Draft Guidance: Requesting Nonbinding Feedback After an FDA Inspection of Your Medical Device Establishment
On Tuesday, February 19th, FDA published a draft guidance for medical device makers which identifies a process for companies to request nonbinding feedback on certain FDA Form 483 deficiencies noted during pre or postmarket inspections.
In its draft guidance, FDA states that the intention of nonbinding feedback is to inform a Sponsor’s implementation of actions in response to inspectional observations. Nonbinding feedback can help medical device companies determine if certain proposed actions would be adequate, therefore avoiding unnecessary investment in solutions which would not satisfactorily address the inspectional observations. In 2017, section 704(h)(2) was added to the Federal Food, Drug, & Cosmetic (FD&C) Act, requiring FDA to provide nonbinding feedback within 45 days of receiving a Sponsor’s request.
Submitting the Request
A request for nonbinding feedback “should come from the person to whom FDA issues the Form FDA 483 or from someone who can otherwise demonstrate to the Agency that they are the owner, operator, or agent in charge of the establishment or a designated representative of such person(s).” The request should be sent to the FDA contact identified to receive the response to the Form FDA and must be made in a ‘timely manner,’ which is defined to be no more than 15 business days after the 483 is issued.
Requests for nonbinding feedback should be submitted with the response to the 483. FDA notes that, although it is being submitted with the response, requests should be a distinctly separate document and should include a cover letter that includes:
- A header that clearly and conspicuously states “Request for Nonbinding FDA Feedback After a Device Inspection”
- The name, address, phone number, and email address of the person submitting the request
- The name, address, and FDA Establishment Identification (FEI) number of the establishment that was inspected and the date(s) of the inspection
- A justification describing how the request meets at least one of the eligibility criteria specified in FD&C Act section 704(h)(2)(B)(ii)), described below
Under Section 704(h)(2), “a request for nonbinding feedback must describe how one or more observations ‘involve a public health priority,’ ‘implicate systemic or major actions,’ or ‘relate to emerging safety issues (as determined by [FDA]).’” In the draft guidance, FDA provides three situations where the request for nonbinding feedback will meet these criteria:
- The conditions documented in the Agency’s observations have resulted in, or are likely to result in, the release of a violative product that may cause death or serious injury.
- The quality system or subsystem(s) deficiencies have resulted in, or likely to result in, “the production of nonconforming, violative, and/or defective finished devices.”
- FDA’s observations relate to an emerging safety issue that is likely to result in death or serious injury if unresolved.
Justification of Request
Requests for nonbinding feedback should contain justification explaining in detail why the requestor believes that one or more of the eligibility criteria are met. If one or more have been met, the FDA is required to provide nonbinding feedback; if none of the criteria have been met, providing nonbinding feedback is not required.
Proposed Responsive Actions
In addition to the eligibility criteria justifications, the request for nonbinding feedback should state the proposed actions in response to the observation(s). These actions should include a detailed description and timeline of the activities the firm plans to take to correct the conditions described in the observations, and how to prevent future recurrence. Submissions should include any supporting documentation for the FDA to adequately evaluate the proposed actions.
FDA’s Response to Nonbinding Feedback
If one or more of the eligibility criteria have been met, FDA is required to provide nonbinding feedback within 45 calendar days of receiving the request. The Agency’s feedback should identify whether the proposed actions appear adequate, partially adequate, or inadequate to address inspectional observations. If the proposed actions are determined to be “partially adequate or inadequate, FDA intends to:
- Acknowledge the submitted proposed actions submitted, including references (where appropriate) to sections, page numbers, or tables
- Explain why the proposed actions (or elements of the proposed actions) do not appear adequate
- Provide a recommendation on what may be needed for FDA to consider the proposed 242 actions (or elements of the proposed actions) adequate”
Nonbinding feedback is the Agency’s best recommendation for the establishment’s specific factual circumstances based on the information provided in the request. This feedback is intended to be used to inform the firm’s implementation of actions in response to inspectional observations and is not required to be implemented by the medical device company. If implemented, nonbinding feedback does not exempt the company from receiving FDA cited inspectional observations or other regulatory action. It is the responsibility of the owners, operators, and agents to ensure compliance with all FDA rules, regulations, and requirements.
FDA issued this draft guidance for comment purposes only and is asking interested individuals to provide written or electronic feedback by April 22, 2019.