At the Food and Drug Administration’s (FDA) Ophthalmic Devices Advisory Committee Panel meeting held this past July, Susan Alpert, PhD, MD, laid down the law on unapproved excimer lasers. The question is, will they enforce it; and if so, when?
According to Alpert, Director of the FDA Office of Device Evaluation, there are no custom excimer lasers. Home built, black box, custom built lasers—whatever term you choose—they don’t qualify as custom devices under the Food, Drug, and Cosmetic statutes. Devices that do are of types not generally available in finished form, are intended for use on an individual patient, and are made in a specific form for that patient. Or, they must meet the special needs of a practitioner and be not generally used by other members of the same profession. Alpert said, "Devices such as excimer lasers clearly don’t fall into that category. They are clearly not for individual patients and they are clearly of a type that is generally used by practitioners of ophthalmology."
Imported lasers, manufactured for use outside the United States and later imported back in, also are unapproved unless the importer shows they are identical to approved Summit and VISX models. And users of unapproved lasers, whether imported or home built, face significant liability.
But, Alpert said, the FDA is giving everyone with an unapproved laser a chance to come into the fold. Her agency will work with users and importers of unapproved lasers to identify the requirements that they must meet for compliance. She proposed a two-tier moratorium program. One tier will be a short grace period during which affected individuals can contact the agency to find out what to do to submit an investigational device exemption (IDE) application or Premarket Approval Application (PMA). The second part will be a period for submissions made by individual or companies. Alpert said, "All will be expected to meet the law. We will publish the time periods."
After the moratorium ends, Alpert continued, the FDA will take action against illegal products with warnings, seizures, and injunctions.
In the wake of this hearing, many in the field are left wondering why the FDA delayed so long before it moved against unapproved lasers. And although promised for release 2 to 3 weeks after the hearing, the agency waited close to 3 months before disclosing any further information on the moratorium. Not until October 10, 1996, did the FDA give any time lines for the process. In a letter signed by Alpert and Lillian J. Gill, Director, Office of Compliance, the agency announced that owners of unapproved lasers, whether homemade or imported, have until January 15, 1997 to identify themselves to the FDA, obtain information about the IDE application process, and submit an IDE application.
One prominent ophthalmologist in the South expressed an erosion of confidence in the FDA. Like many of those practicing within IDE guidelines, supporting clinical and regulatory employees, complying with necessary paperwork, and maintaining extensive databases, he is unhappy with users of unapproved lasers. He said that short of threatening letters and warnings, the FDA has done nothing about the issue in 18 months. "What message does that send to the professional community about how serious the FDA is? They expect detailed and strict compliance among doctors and companies with IDEs while colleagues operate with a fraction of the cost and effort, carrying no regulatory burden and paying no Pillar Point fees. I am not talking about a legal message but a perception that, to the professional community, it doesn’t matter what they do, because the FDA won’t do anything about it."
Another FDA official, Morris Waxler, PhD, was reluctant to characterize the period during which the FDA failed to act against illegal lasers as either unduly long or unreasonable. "Some of the questions have been rather thorny legal ones. I think the FDA has just been trying to solve a series of problems and we need to take diligent time and not interfere with anybody’s rights in these matters. These are issues that one cannot openly discuss and there are ambiguities in the law that have to be really worked with. It has taken probably longer than any one would have expected but I don’t think people anticipated the nuances in this matter to be so difficult."
Despite numerous complaints from industry and ophthalmologists over the past two years, the agency has also been slow to act on imported lasers. It only issued an import alert against used Summit lasers last February. As a result, the US Customs Service reportedly detained a number at their point of entry. And, recently one importer has agreed to comply with FDA requirements.
Finally at the July meeting, Alpert announced that the FDA is working with the Society for the Advancement of Laser Technology (SALT) on a certification process for importers to demonstrate that their lasers are identical to the approved lasers.
The FDA did hold to its promise of a certification process. The October 10 letter also gave owners of imported lasers—if the laser was originally manufactured by the holder of an FDA-approved PMA—the option of certifying that the laser is identical to the approved ones. Owners are advised to have their lasers certified quickly; if the FDA rejects the certification, then the owner must still hand in an IDE application by the January deadline. Waxler said that the FDA established the certification process without further input from SALT beyond what that organization gave prior to the hearing.
Meanwhile many users of homemade and imported unapproved lasers argue that the FDA view distorts existing regulations and statutes. One longtime consultant in the East claimed that custom lasers do indeed exist and are devices that differ from the lasers approved by the PMA process. He added that the FDA position turns the regulation on its head. "The regulation says you have to deviate from something on the market. Alpert is saying if there is something on the market, you cannot have a custom device."
But some physicians represented by the consultant have opted to enter the amnesty program, and he has worked out general terms with the FDA on their behalf. He said, "They are complying because they would rather not fight the FDA."
He claimed that the FDA has not acted on unapproved lasers because the agency knows it would have no success in court. "All the agency can do is to make arguments and coerce doctors into doing something like the amnesty program. They have spent two years only talking and writing warning letters to five doctors about their devices. In fact I represent some doctors who have received FDA inspections but no warning letters."
Washington attorney Wayne Matelski also represents physicians with unapproved lasers. He believes the FDA has taken so long to come to grips with the custom laser issue because many users are extremely prominent physicians. He said, " These doctors want to use—and are almost ethically obligated to use—up-to-date excimers on their patients. Many doctors believe that they should be able to their build own custom lasers, which incorporate some of the newer changes."
But, whether home built or imported, unapproved lasers may actually hold back new technology here. As Michael Moretti, editor of Medical Laser Insight, noted in the July 1, 1996 issue of Ocular Surgery News1, "The lack of regulatory enforcement against unapproved lasers in this country is very discouraging to legitimate devices manufacturers that spend millions of dollars each year in sincere attempts to conform to the most arduous product approval system in the world. In fact, this situation makes it even less desirable for companies to invest vast financial and management resources in bringing new technology to market."
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