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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Valley Electronics GmbH 12/6/10

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 

10903 New Hampshire Avenue

Silver Spring, MD 20993 

Warning Letter

DEC 06 2010 
 
VIA United Parcel Service
 
Dr. Hubertus Rechberg
VE Valley Electronics GmbH
Wengwies 2
D-82438 Eschenlohe
Germany
 
RE: Lady-Comp USATM, Baby-Comp, and Pearly
 
Refer to GEN0901115 when replying to this letter.
 
Dear Dr. Rechberg:
 
The Food and Drug Administration (FDA) has learned that your firm is manufacturing the Lady-Comp, Baby-Comp, and Pearly fertility monitors and marketing these devices 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, 21 U.S.C. 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or intended to affect the structure or function of the
body. The Office of Compliance (OC) in the Center for Devices and Radiological Health (CDRH) reviewed your websites at http://www.lady-comp.de/en and https://shop.valley-electronics.ch/de/?lang=de_en, which advertise the products Lady-Comp, Baby-Comp, and Pearly. Your websites promote these devices for uses for which you have not obtained marketing approval or clearance, which is a violation of the law.
 
A review of our records indicates that we cleared a premarket notification (510(k)) for Lady-Comp USATM, K050094, on April 20, 2006. As indicated in the letter dated April 20, 2006, we cleared this device only “for measuring and recording basal body temperature (BBT) as
an aid in ovulation prediction to facilitate conception (not to be used for contraception).” Your websites contain the following claims, which represent or suggest that these devices are intended to be used for contraception:  
 
  •  “Baby-Comp is suitable for . . . safe contraception.”  
  • “Especially for women who are always on the road this small device [Pearly] is the best solution for a health contraception.”  
  • [Lady-Comp] is the ambitious, scientifically advanced cycle computer that was tried and tested for decades to ensure natural contraception.”
 
The Lady-Comp USA™, Baby-Comp, and Pearly are adulterated under Section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do not have approved applications for premarket approval (PMA) in effect pursuant to Section 515(a) of the Act, 21 U.S.C. 360(a), or approved applications for an investigational device exemption (IDE) under Section 520(g) of the Act, 21 U.S.C. 360j(g). The devices are 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 devices 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.
 
In addition, Lady-Comp USA™ is misbranded under Section 502(a), 21 U.S.C. 352(a), misbranding by reference, in that your websites contain a statement that is misleading in accordance with 21 CFR 807.97, because such a statement creates an impression of official approval of a device due to clearance of a premarket notification submission. Specifically, your websites state that Lady-Comp is “Approved by the FDA.”  This device was not approved by the FDA, but was determined to be substantially equivalent within the meaning of Section 513(i)(1)(A) of the Act, 21 U.S.C. 360c(i)(1)(A).
 
The FDA requests that Valley Electronics GmbH immediately cease making claims, identical or similar to those described above for Lady-Comp, Baby-Comp, and Pearly.  You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action, which may include detaining your devices without physical examination upon entry into the United States until the corrections are completed. 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.  Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
 
Please submit a written response to this letter within fifteen (15) working days from the date you receive this letter, describing your intent to comply with this request, listing all promotional materials for Lady-Comp, Baby-Comp, and Pearly the same as or similar to those described above, and explaining your plan for discontinuing use of such materials. Please provide a translation of documentation not in English to facilitate our review. Please direct your response to Paul Tilton at the Food and Drug Administration, 10903 New Hampshire Ave., WO66-3540, Silver Spring, MD 20993. If you have any questions about the content of this letter please contact Emre Genca by telephone at 301-796-5770 or by fax at 301-847-8137.
 
Finally, you should know that the violations discussed in this letter do not necessarily constitute an exhaustive list.  You should understand that there are many FDA requirements pertaining to the manufacture and marketing of devices. 
 
It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. 
 
 
Sincerely yours,
 
/S/ 
 
Steven D. Silverman
Director
Office of Compliance
Center for Devices and
Radiological Health