September 16th, 2009
Dear Mr. Kantis,
Thank you for your comments. The Safe
Medical Devices Act of 1990 explicitly directed that User
Facilities, like Manufacturers, were to provide the FDA with
device related injury/death reports. The MDR regulation, 21
C.F.R. Part 803, requires maintenance of and adherence to
documented procedures in order to implement these
requirements. ALL LASIK Ambulatory Surgical Facilities (ASFs)
must comply with these requirements, because failure to do
so is a violation of law.
I have been intimately involved since 1970
with the development and implementation of FDA’s ‘device’
regulatory authority as a FDA employee and in the practice
of law. The CDRH has been relatively aggressive in pursuit
of complaints against manufacturers who allegedly do not
comply with the MDR regulation, but nearly silent about User
Facility compliance.
CDRH failure to investigate the LASIK ASF
‘industry’ is a pitiful disgrace that deprives the CDRH of
the very ‘safety’ information that the 1990 Amendments were
designed to produce. When CDRH Director Schultz in a 2008
letter received by me acknowledged that three(3) LASIK ASFs
had been inspected since around the year 2000, he did not
mention whether any one of these LASIK ASFs had been
inspected for compliance with the MDR regulation. In spite
of requests by you, others, and me since then, it appears
that the FDA/CDRH has not yet inspected a single LASIK ASF
to determine whether documented procedures are and have been
in place as required and whether there has been compliance.
Surely,
the FDA has sufficient resources to inspect at least one
nearby LASIK ASF near one of its many offices during a
ten(10) year period of time. I do hope that Commissioner
Hamburg will seek the truth and ask the CDRH to explain what
it has done to answer whether LASIK ASFs have been and are
complying with the MDR regulation requirements.
Cordially,
Larry R. Pilot, ESQ