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