FDA is issuing final guidance on how device firms may request review of a decision to withhold issuance of a Certificate to Foreign Government (CFG). What is a CFG? In many cases, foreign governments will seek official assurance that products exported to their countries are in compliance with U.S. law or meet specific U.S. regulations, such as Quality System Regulations (QSR). In these cases, firms may request that FDA provide a CFG. If a domestic firm’s manufacturing establishment has an outstanding Form 483, due to a bad QSR inspection, or is conducting a Class I or II product recall, the non‑compliance may lead FDA to refuse to issue a CFG until it is resolved.
In 2017, Congress amended the export provisions of the Federal Food, Drug, and Cosmetic Act (FDCA) to establish specific procedural rights and appeal options for device companies faced with a CFG denial. The following year, FDA issued a draft guidance on how the statutory change will be implemented. We explained the background and summarized FDA’s draft guidance here.
Our main complaint about the draft guidance was a lack of clarity and detail on implementation of the statute. We are pleased to report that the final guidance is improved in this regard. Here are the key points:
Grounds for Denial
Pursuant to the amendment to the FDCA, a CFG may denied in the event of an injunction, a seizure action, a Class I or II voluntary recall, or an establishment out of compliance with the QSR.
If a CFG is denied due to non‑compliance with the QSR, FDA will provide a “substantive summary” of the specific grounds for non‑compliance. It appears likely that this information will be distilled from the inspectional observations in a Form 483.
Plan of Correction
A firm may submit a “plan of correction” responsive to the substantive summary. FDA states that they interpret a plan of correction to be a response to inspectional observations. The procedure is as follows:
- The firm submits via e‑mail the steps it is taking to address the inspectional observations and prevent a recurrence, including timeframes for completing the actions. The email subject line should state “Plan of Correction.”
- FDA reserves the right to seek clarification of the plan before making a decision. FDA intends to provide a response within 90 days, with due allowance for the complexity of the issues and the responsiveness of the firm.
- If the plan is determined to be sufficient, FDA will issue a CFG (provided no other grounds of denial are present).
Appeal of Denial
A firm whose CFG has been denied has a right to supervisory review and an opportunity for an in‑person meeting or teleconference. The appeal must be submitted by email within 60 days of denial. CDRH will follow its usual procedures (per this guidance). CBER will use its Formal Dispute Resolution Request (FDRR) process (per this guidance). In both cases, FDA indicates an intent to follow the standard timelines in Section 517A(b) but does not guarantee it, which may be a questionable interpretation of the statute, which directed FDA to follow the standards of the Section 517A(b).
A firm whose CFG has been denied has the right to request review of the decision based upon new information, including evidence that corrective actions are being or have been implemented to address FDA’s substantive summary of the grounds for denial. Once again, this review can be obtained by submitting an email. Once again, FDA says it will target 90 days for a decision, to the extent possible.
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A right of supervisory appeal of a CFG denial is unlikely to be successful unless FDA has issued a Form 483 that is plainly wrong (a high bar in most cases). The plan of correction (or the request for review based on new information) appear to offer greater potential. Since it is likely that FDA will put the most important QSR non-compliance in its substantive summary, a firm could use the vehicle of a plan of correction to help unlock CFGs sooner than would ordinarily be the case. Additionally, there may be a collateral benefit of obtaining a relatively quick read on FDA’s assessment of a corrective action plan addressing the most serious Form 483 issues. Certainly, it remains to be seen how FDA actually implements the new procedures, but the final guidance holds out the prospect of improved communication with FDA as firms seek to resolve outstanding Form 483s.