Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
10903 New Hampshire Ave.
FEB 9 2011
Via United Parcel Service
Dr. Eric L. Buckland
Director, President, and Chief Executive Officer
104 T.W. Alexander Drive
Park Research Center, Building 2
Research Triangle Park, North Carolina 27709
RE Bioptigen High Performance Pediatric SD-OCT Hand-held Imaging System
Refer to GEN1000226 when replying to this letter.
Dear Dr. Buckland:
The Food and Drug Administration (FDA) has learned that your firm is marketing the Bioptigen High Performance Pediatric SD-OCT Hand-held Imaging System in the United States (U.S.) without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
Under section 201(h) of the Act, the Bioptigen High Performance Pediatric SD-OCT Hand-held Imaging System is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body, 21 U.S.C. 321(h). The Act requires that manufacturers of devices that are not exempt obtain marketing approval or clearance for their products from the FDA before they may offer them for sale. This helps protect the public health by ensuring that new devices are shown to be both safe and effective or substantially equivalent to other devices already legally marketed in this country for which approval is not required.
The Office of Compliance (OC) in the Center for Devices and Radiological Health (CDRH) reviewed: your website, www.bioptigen.com, several brochures distributed by your firm at the American Academy of Ophthalmology (AAO) meeting October 24-27, 2009, and a peer-reviewed article distributed at the AAO meeting, “Imaging the Infant Retina with a Hand-held Spectral-Domain Optical Coherence Tomography Device.”
FDA cleared a premarket notification (510(k)) for the Bioptigen Spectral Domain Ophthalmic Imaging System, K063343, on December 13, 2006. The cleared Bioptigen Spectral Domain Ophthalmic Imaging System includes a tabletop-standing scanner. The cleared indication for use (IFU) statement for your Bioptigen Spectral Domain Ophthalmic Imaging System is:
intended to acquire, process, display, and save depth-resolved images of ocular tissue microstructure using Spectral Domain Optical Coherence Tomography. It is primarily intended for the imaging of retinal tissue, but the cornea, sclera, and conjunctiva can also be imaged by changing the focal position. Indications for use include the evaluation of ophthalmic tissue in routine clinical examinations and as an aid in the diagnosis of conditions that affect the optical scattering properties of ocular tissue.
The Bioptigen High Performance Pediatric SD-OCT Hand-held Imaging System has a modified device design, a handheld scanner head. Your website and brochures contain claims that the Bioptigen High Performance Pediatric SD-OCT Hand-held Imaging System may be used for specific diagnostic purposes, such as Retinopathy of Prematurity, Pediatric Retinoblastoma, and Shaken Baby Syndrome. FDA considers the changes or modifications to be significant under 21 CFR 807.81(a)(3) and outside your 510(k) clearance.
A review of our records reveals that you have not obtained marketing approval or clearance before you began offering your product for sale, which is a violation of the law. Specifically, the Bioptigen High Performance Pediatric SD-OCT Hand-held Imaging System is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). The device is also misbranded under section 502(o) the Act, 21 U.S.C. 352(o), because you did not notify the agency of your intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. 360(k). For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. 360(k), is deemed satisfied when a PMA is pending before the agency 21 CFR 807.81(b). The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to seizure, injunction, and /or civil money penalties. Also, Federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts.
Please let this office know in writing what steps you have taken to correct the problem within fifteen (15) working days from the date you received this letter. We also ask that you explain how you plan to prevent this from happening again. If you need more time, let us know why and when you expect to complete your correction. Please direct your response or any questions you may have to: Ronald L. Swann, Chief, Dental, Ear, Nose, Throat, and Ophthalmic Devices Branch at the Food and Drug Administration, 10903 New Hampshire Avenue, WO66-3534, Silver Spring, MD 20993, facsimile at 301-847-8137. We remind you that only written communications are considered official.
Finally, you should understand that there are many FDA requirements pertaining to the manufacture and marketing of devices. This letter pertains only to the issue of premarket review for your device and does not necessarily address other obligations you have under the law.
Steven D. Silverman
Office of Compliance
Center for Devices and