FDA’s Device Center Issues Two Guidances for Appeals

The FDA has released two guidances for appeals of regulatory decisions, one each for mammography facilities and the other for medical device premarket reviews. These are the first two final guidances to come out of the FDA’s device center to date in 2022, and both describe a multi-stage appeal process available to the affected parties.

The Mammography Quality Standards Act of 1994 requires that a mammography facility be accredited and undergo periodic review by the accreditation organization of record. A new guidance states that a mammography facility that disagrees with an accreditation body’s decision to not accredit or reaccredit the facility can appeal the decision directly to that accreditation body. If the facility’s administrators still disagree with the results of that appeal, they can request a review by the director of the FDA’s Division of Mammography Quality Standards (DMQS). The operators of the facility can request a formal hearing before an appeals board at the Department of Health and Human Services if they are dissatisfied with the outcome at the DMQS review.

The appeals guidance for premarket decisions also presents a staged review process, but has a channel for appeals that can skip a stage when circumstances warrant. This telescoped review process allows a manufacturer to appeal directly to the next-level supervisor or even to the director of the Center for Devices and Radiological Health (CDRH).

There are several regulatory decisions that fall under the scope of this guidance, such as a not-substantially-equivalent (NSE) determination for 510(k) devices. Denials of PMA applications and investigational device exemptions are also eligible for this appeals process, as are FDA refusals to admit a device into the breakthrough devices program. These are all deemed significant regulatory decisions, while a number of other FDA actions are considered non-significant decisions, such as requests for additional information for 510(k) applications.

The standard process for appealing a significant decision is to appeal the decision to the next level up the CDRH organizational chart. In most instances, this would be an appeal to the Office of Health Technology of which the examining office is part. From there, an appeal would rise to the Office of Product Evaluation and Quality, then the office of the center director. This type of appeal could eventually rise to the office of the FDA commissioner. Under some circumstances, an appeal can be made directly to the FDA commissioner, but this is for exceptional cases involving an immediate hazard to public health or other similar considerations.

The telescoped review can take an appeal as far up as the center director, but there are conditions applied to this type of review. The appeal must be based on a significant regulatory or policy question, or revolve around a novel or unresolved question of medical science. A telescoped review can be used when the next-level supervisor has been involved in the regulatory action under review, but the agency is within its rights to decline to undertake a telescoped review.

These reviews can be handled with teleconferences and in-person meetings, although the manufacturer has the option of a paper review. The FDA can consult with an outside expert to process an appeal, but an appeal can also be reviewed by an advisory panel that would offer scientific expertise. There is also the dispute resolution advisory panel process, which is a separate function from the standard medical device advisory committee process.

Among the other appeals processes described in this guidance is the citizen’s petition, the petition for administrative reconsideration of action, and the petition for administrative stay of action. The guidance states that the FDA is often asked about judicial remedies, which can be filed with or without the agency’s assent. However, the guidance recommends that any potential litigants go through the entire course of internal FDA appeals before filing suit.