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Dear Doctor:
This is to provide an update on the Food and Drug Administration's
(FDA) policies regarding lasers for refractive surgery. When
we last wrote you on October 10, 1996, we described two situations
in which unapproved lasers were being operated without FDA approval:
(1) unapproved lasers manufactured by the owner, by someone else
for the owner, or by a corporate entity ("black box"
lasers); and (2) importation of Summit lasers originally manufactured
in the United States and exported for use overseas, or manufactured
overseas before the company had received FDA approval to market
its devices in the U.S. ("gray market" lasers). We
have new information for you with respect to both types of lasers.
First, we have uncovered through our own investigations what
appears to be a pattern of serious patient injuries attributed
to the use of some "black box" lasers. These include
several injuries requiring corneal transplantation, additional
(and repetitive) corneal surgery, severe night vision problems,
and frequent overcorrections ( >+2.00D). These injuries and overcorrections
appear to be caused by a laser beam that has a relatively small
optical zone, has considerable inhomogeneity, and produces a non-spherical
ablation pattern.
The injuries from "black box" lasers demonstrate the
importance of evaluating the safety and effectiveness of lasers
for refractive surgery with a limited number of patients under
an FDA-approved Investigational Device Exemption (IDE) and the
oversight of an Institutional Review Board, as required by the
Federal Food, Drug, and Cosmetic Act (the Act). Data from such
studies is critical in establishing the risks and benefits of
particular laser designs.
In addition, "black box" lasers may not have adequate
fail-safe mechanisms and equipment hazard analyses; furthermore,
software validation and verification may not have been performed.
We therefore regard the use of unapproved lasers for refractive
surgery as a serious public health problem.
Second, with respect to "gray market" lasers, many of
the physicians who imported these lasers communicated their belief
to the agency that their lasers were the same as the approved
Summit lasers. FDA attempted, in the exercise of its enforcement
discretion, to resolve the matter and accommodate these physicians
by providing an opportunity for them to certify that their lasers
were identical in all relevant aspects to approved lasers.
Our experience with certification has led us to conclude that
the process described in our October 10 letter cannot be implemented
legally. Because imported Summit lasers do not meet all of the
conditions for approval of the Summit premarket approvals (PMAs),
no imported Summit lasers may be considered to be covered by those
PMAs unless the laser has been remanufactured by Summit to conform
to the specifications of the company's approved lasers. Unapproved
lasers used outside of an FDA-approved clinical trial violate
the Act.
By now you are likely aware that FDA has seized "black box"
lasers that have been illegally distributed and are being used
without an approved IDE. We intend to take additional regulatory
action against other unapproved "black box" and "gray
market" lasers used in refractive surgery.
Both "black box" and "gray market" lasers
for refractive surgery are unapproved Class III medical devices
that can be used on patients only after FDA has approved an IDE
for a clinical trial. Under an IDE, only a limited number of
subjects with specific conditions may be treated. The IDE process
is designed to investigate the safety and effectiveness of a device
either to obtain information for publication or to generate the
data needed to obtain marketing approval from FDA. An IDE is
not an approval for the commercial treatment of patients.
Any study conducted under an IDE is subject to all IDE regulations.
You must understand, however, that the market approval process
that follows completion of IDE studies requires more than clinical
data; for example, the application also must include detailed
engineering and manufacturing specifications.
Clinicians wishing to conduct a clinical trial of a refractive
surgery laser can obtain information by visiting FDA's website
at http://www.fda.gov/cdrh/ode/laser.html. Look for Document
2093. If you have further questions, contact Morris Waxler, Ph.D.,
at (301) 594-2018.
We know you share our concern that patients receive the safest
treatment possible when undergoing refractive surgery with lasers,
and we look forward to your cooperation in this matter. In addition,
if you are aware of any patient injuries associated with the use
of lasers for refractive surgery, we request that you report them
to the FDA. You may report adverse events to FDA's MedWatch program
at telephone 1-800-FDA-1088 or fax 1-800-FDA-0178.
| Sincerely yours, |
| Lillian J. Gill | Susan Alpert, Ph.D., MD |
| Director | Director |
| Office of Compliance | Office of Device Evaluation |
| Center for Devices | Center for Devices |
| and Radiological Health | and Radiological Health |
Updated 7/2/1997
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