| Ragnar 2005-09-24, 2:40 pm |
| You must be running out of venom. Re-hashing 8 year old news is
pretty pathetic.
On 13 Sep 2005 09:49:16 -0700, "Brent Hanson - LASIKFRAUD.com"
<administrator@lasikcourt.com> wrote:
>Food and Drug Administration
>2098 Gaither Road
>Rockville, MD 20850
>
>WARNING LETTER
>
>Nicholas C. Caro, M.D.
>4145 W. Peterson, Suite 200
>Chicago, Illinois 60640
>
>Dear Dr. Caro,
>
>The Food and Drug Administration (FDA) inspected your medical practice
>located at the above address on April 23, 1997, and determined that you
>have an unapproved excimer laser system, which was manufactured by
>Photon Data, Inc., Winter Park, Florida and assembled by [name redacted
>by FDA] Excimer Laser systems are considered to be devices within the
>meaning of section 201(h) of the Food, Drug and Cosmetic Act (the Act).
> Excimer laser systems are Class III devices which are required to have
>in effect an approved application for premarket approval (PMA) or an
>approved Investigational Device Exemption (IDE).
>
>On January 24, 1997, you submitted an application for an IDE for your
>excimer laser system for use in refractive eye surgery. On February
>14, 1997, the Office of Device Evaluation (ODE) at FDA's Center for
>Devices and Radiological Health (CDRH) sent you a letter disapproving
>your IDE application. You may not use your excimer laser system to
>treat human subjects until you have received either an approved PMA
>under section 515(a) of the Act, or an approved IDE under section
>520(g).
>
>Your excimer laser system is adulterated under section 501(f)(1)(B) of
>the Act because it is a Class III device under section 513(f), which is
>required to have in effect an approved PMA or an approved IDE, and no
>such PMA or IDE is in effect for it. Medical devices used by
>physicians in the course of their practice to treat patients are
>"marketed" and "held for sale" within the meaning of the Act. Further,
>your continued use of this device to treat patients is also a violation
>of the Act.
>
>In addition, your excimer laser system must comply with the
>requirements of Federal Performance Standards for lasers which are
>found in 21 CFR Title 21 of the Code of Federal Regulations, Part 1040.
> We acknowledge receipt of a Laser Product Report from you for this
>excimer laser system. However, FDA found this Report to be deficient.
>Therefore, your excimer laser system is in violation of the Federal
>Performance Standards for lasers.
>
>Please note that FDA does not consider your excimer laser to be a
>custom device. Section 520(b) of the Act establishes five conditions,
>each of which must be met by a device to be a custom device. The Act's
>custom device definition requires that the device be made to meet
>either the specific anatomical requirements of an individual patient or
>the special needs of an individual practitioner; a practitioner's
>special needs may be either an individual anatomical need or a special
>practice need that is not shared by other physicians.
>
>We do not believe the requirements of your medical practice are unique
>because they are shared by numerous other health professionals. In
>addition, we do not believe your device is designed to meet any special
>anatomical needs that you or an individual patient of yours may have.
>Accordingly, your laser is not a custom device and is not exempt from
>the requirement under the Act that this device must have an approved
>PMA or IDE in effect.
>
>Please notify this office within 15 working days of your receipt of
>this letter as to what, if any, actions you are taking or plan to take
>to bring your device into compliance with the Act. Your response
>should also clearly state whether or not you have ceased using the
>device to treat patients. Failure to immediately and completely cease
>clinical use of the device upon receipt of this letter, and failure to
>bring your device into compliance with the Act, may result in
>regulatory action by FDA without further notice. These actions
>include, but are not limited to, seizure, injunction, and/or civil
>penalties. Please note that no extensions of the 15 day response
>period will be given.
>
>Your response should be sent to the attention of Mary-Lou Davis,
>Dental, ENT and Ophthalmic Devices Branch (HFZ-331) at the letterhead
>address. In addition, please send a copy of your response to Mr.
>Stephen Dr. Eich, Compliance Officer, Food and Drug Administration, 300
>S. Riverside Plaza, 5th Floor, Suite 550 South, Chicago, Illinois
>60606. If you have further questions, please contact Mary-Lou Davis at
>(301) 594-4613 extension 127 or FAX: (301) 594-4638.
>
>Sincerely yours,
>Lillian J. Gill
>Director
>Office of Compliance
>Center for Devices and Radiological Health
>
>
>--------------------------------------------------------------------------
>
>The FDA ultimately seized Dr. Nicholas Caro's "homegrown" laser as is
>documented here: www.fda.gov/bbs/topics/ANSWERS/ANS00828.html
|