To Ask, or Not to Ask, That is the Question: FDA Guidance on Nonbinding Feedback After Certain Inspections of Device Establishments

FDA recently issued a draft guidance document, Nonbinding Feedback After Certain FDA Inspections of Device Establishments, which outlines the process for obtaining FDA feedback on proposed remedial actions in response to observations issued on a Form 483, the Agency’s Inspectional Observations Form, following an inspection.

Background

Section 702 of the FDA Reauthorization Act of 2017 (FDARA) amended the Federal Food, Drug, and Cosmetic Act (FDCA) to require FDA to provide nonbinding feedback in certain circumstances after an FDA inspection of a device establishment.  Specifically, FDCA section 704(h)(2) states:

(A) The Secretary shall, with respect to a request described in subparagraph (B), provide nonbinding feedback with respect to such request not later than 45 days after the Secretary receives such request.

(B) A request described in this subparagraph is a request for feedback—

(i) that is made by the owner, operator, or agent in charge of such establishment in a timely manner; and

(ii) with respect to actions proposed to be taken by a device establishment in a response to a report received by such establishment pursuant to subsection (b) that involve a public health priority, that implicate systemic or major actions, or relate to emerging safety issues (as determined by the Secretary).

Statutory Eligibility and Justification

In the draft guidance, FDA reiterates the statutory criteria for nonbinding feedback: the request must describe how one or more observations “involve a public health priority,”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]).”  The request must, therefore, include a justification as to why one of the eligibility criteria is met.  FDA provides the following examples of observations that would likely meet the statutory criteria for nonbinding feedback:

• An observation regarding conditions that, if unaddressed, are likely to result in the release of a violative product that may cause death or serious injury.
• An observation regarding quality system or subsystem deficiencies which have or are likely to result in a nonconforming, violative and/or defective device.
• An observation relating to an emerging safety issue that, if unresolved, is likely to result in the release of devices likely to cause death or serious injury.

Request for Feedback

Eligible requests should be submitted no later than 15 business days after a Form 483 is issued and should be addressed to the same FDA contact responsible for receiving any response to the Form FDA 483.  Any response to a Form 483 should be distinct from a request for nonbinding feedback, although the two submissions can be sent together.

The request should state the inspectional observation for which feedback is being requested as well as the proposed remedial actions, including a proposed timeline.

FDA’s Response

Upon receiving a request, FDA will first determine whether the eligibility criteria are met.  If not, FDA will notify the requestor within 45 days that the request is ineligible. If the request does meet one of the criteria, FDA is required to provide nonbinding feedback within 45 calendar days.  This feedback will indicate whether the proposed actions appear adequate, partially adequate, or inadequate.  Where FDA’s feedback is that a proposed action is partially adequate or inadequate, FDA will provide an explanation and a recommendation as to what may be needed for FDA to consider the proposed actions adequate.

Limitations of Feedback

The draft guidance articulates the limitations of the feedback provided by FDA, watering down most of the utility of this program.  Specifically, the guidance notes that FDA’s feedback “may not adequately address the cause of the problems that led to the inspectional observations, and additional action may be warranted.”  The guidance also notes that FDA’s feedback does not prevent additional observations or regulatory action.  Any response from FDA would, therefore, provide little comfort to a sponsor who had already admitted that a Form 483 observation “involve[s] a public health priority,” “implicate[s] systemic or major actions,” or “relate[s] to emerging safety issues (as determined by [FDA]).”  The process, therefore, puts sponsors in a lose-lose situation.  While the admissions could be used in an enforcement action or a products liability lawsuit to demonstrate knowledge of a problem, a failure to request available feedback could be used to show negligence or willful ignorance of the same.

We encourage stakeholders to review the draft guidance and provide comments under docket number FDA-2018-D-4711.  The comment period closes on April 22, 2019.