Inspections, Compliance, Enforcement, and Criminal Investigations
Medispec, Ltd. 3/12/10
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|10903 New Hampshire Avenue|
Silver Spring, MD 20993
MAR 12 2010
40 Hataasiya St.
P.O. Box 292
Yehud, Israel 56101
RE: Radialspec™ device
Refer to GEN 0901319 when replying to this letter.
The Food and Drug Administration (FDA) has learned that your firm is marketing the Radialspec™ device in the United States (U.S.) without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
The Office of Compliance (OC) in the Center for Devices and Radiological Health (CDRH) reviewed www.medispec.com for the Radialspec™ device. The product is a device within the meaning of Section 201(h) of the Federal Food, Drug, and Cosmetic Act.
The Radialspec™ device 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) of 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 C.F.R. 807.81(b). The kind of information you need to submit in order to obtain approval or clearance for your device is available through 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.
Given the serious nature of the violations of the Act, the Radialspec™ device, manufactured by your firm is subject to refusal of admission under section 801(a) of the Act, 21 U.S.C. § 381(a), in that it appears to be adulterated. As a result, FDA may take steps to refuse these products, known as "detention without physical examination," until these violations are corrected. In order to remove the devices from detention, you should provide a written response to this Warning Letter as described below and correct the violations described in this letter. We will notify you if your response is adequate, and we may need to inspect your facility to verify that the appropriate corrections have been made.
Also, U.S. 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. Additionally, premarket approval applications for Class III devices to which the Quality System regulation deviations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. Please provide a translation of documentation not in English to facilitate our review.
Your response should be sent to:
Acting Chief, Orthopedic and Physical
Medicine Devices Branch
Center for Devices and
WO 66, Room 3621
10903 New Hampshire Avenue
Silver Spring, MD 20903-0002
If you have any questions about the content of this letter please contact: Amy Skrzypchak at phone number (301) 796-5613 or fax number (301) 847-8138.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations by your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.
Timothy A. Ulatowski
Office of Compliance
Center for Devices and
Cc: Anil Dhingra
20410 Observation Drive: Suite 102
Germantown, Maryland 20876