By Mitchell S. Fuerst, and Kelly L. Lightfoot - Fuerst Ittleman, PL
From tongue depressors to tanning beds to pacemakers, the U.S. Food and Drug Administration (FDA) regulates medical devices under a specific set of statutes, regulations, and policies. Many of these devices are reviewed by the agency before entering the market under the 510(k) premarket notification or premarket approval (PMA) programs. FDA regulations governing premarket submission processes are confusing and can be even further complicated when disputes arise between FDA and a device sponsor during the review process, which frequently occurs.
Common sources of these disputes are FDA requests for additional information from the device sponsor (likely manufacturers or distributors) after an initial submission. Often these requests arise when the agency deems data submitted by the sponsor to be deficient. Device sponsors usually find these requests overly burdensome or inappropriate. Disputes may also arise from a negative agency decision, like the issuance of a “not substantially equivalent” (NSE) determination for a 510(k) device.
When faced with disputes, device sponsors may not be aware of the administrative and judicial options available.
Administratively, a sponsor can file several types of petitions and requests with FDA. These include citizen petitions, petitions for administrative reconsideration, and requests for an internal agency review of the decision. FDA also has other formal means of dispute resolution, including formal evidentiary public hearings, public hearings before a board of inquiry, hearings before a public advisory committee, and public hearings before the FDA commissioner.
Each of these options has certain requirements – including filing timeframes – which the sponsor must satisfy to use the particular resolution process. These options can be tedious for device sponsors as they often involve protracted administrative proceedings, in‑person meetings with the FDA, and written agency correspondence. Additionally, as none of these options imposes a timeframe on FDA to render a final decision, engaging in these options can lead a device sponsor into an interminable administrative quagmire with little possibility for reprieve.
The FDA also utilizes unwritten “preferences” and “policies” in handling administrative procedural issues, which can be unpredictable and unclear for device sponsors. In situations where FDA utilizes unwritten procedures, a sponsor can fall into administrative traps, which may be unlawful or ultra vires. Thus, having a robust understanding of FDA administrative procedure in these circumstances is critical. However, administrative options are often the first choice for small businesses as the cost of litigating FDA can be prohibitive. Dealing with FDA administratively can be effective if the sponsor has a good working relationship with the FDA reviewer assigned to the sponsor’s device.
Judicial remedies are also available to sponsors. The Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. § 360g(a)) provides for nine specific situations in which a party may file a petition with federal courts of appeal for judicial review. Under 21 U.S.C. § 360g, any party adversely affected by a “an FDA determination regarding whether a medical device is “substantially equivalent” (SE) may seek judicial review in a United States Court of Appeals within thirty days of the order. In litigation currently before the D.C. Circuit, FDA has argued that this statute does not provide for direct judicial review of orders that a device is not SE. Instead, according to the FDA, this statute only provides relief in the face of a SE determination.
Fuerst Ittleman, PL, on behalf of a device sponsor, has countered that the statute and legislative history of the FDCA clearly provide for direct judicial review of both NSE and SE orders. The parties are awaiting a decision on this issue, a question of first impression for the Court.
Additionally, under certain circumstances, device sponsors may seek a writ of mandamus (under 28 U.S.C. § 1651) requesting a federal court of appeals to exercise jurisdiction over a particular matter. To utilize this option, however, there are several prerequisites that a sponsor must satisfy. The device sponsor must show, for instance, that FDA acted unreasonably and that the public has been harmed by FDA’s actions. A writ of mandamus is an extraordinary remedy and the burden on the sponsor is quite onerous.
While administrative means of device dispute resolution can be effective, judicial pathways also exist and are sometimes the most effective means for conclusion of a dispute with the FDA. The choice of which path to take is a business decision that must be evaluated from the device sponsor’s unique perspective. Sponsors should always be aware that device dispute resolution, both administrative and judicial, can be lengthy, possibly adding six months or more onto the review time. Fuerst Ittleman regularly represents medical device sponsors in FDA device submissions, appeals, and disputes.
By Mitchell S. Fuerst, and Kelly L. Lightfoot
Fuerst Ittleman, PL
1001 Brickell Bay Dr., 32nd Floor
Miami, FL 33131
305-350-5690
www.fuerstlaw.com
South Florida Legal Guide 2012 Edition