| Public Health Service Food and Drug Administration |
10903 New Hampshire Avenue Silver Spring, MD 20993 |
Department of Health and Human ServicesWarning Letter
DEC 06 2010
VIA United Parcel Service
Michael J. Cartain
Lady-Comp USA
RaXMedical, Inc.
410 East Terrace Heights
Jeffersonville, Indiana 47130
RE: Lady-Comp USATM, Baby-Comp, and Pearly
Refer to GEN0901115 when replying to this letter.
Dear Mr. Cartain:
The Food and Drug Administration (FDA) has learned that your firm is marketing the Lady-Comp USATM, Baby-Comp, and Pearly fertility monitors in the United States (U.S.) without marketing 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 www.ladycompusa.com and www.raxmedical.com, 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, 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 statements that represent or suggest that the Lady-Comp, Baby-Comp, and Pearly are intended to be used for contraception:
- “Lady-Comp assists with safe, reliable and natural birth control.”
- “Baby-Comp assists with family planning and reduced fertility.”
- “Pearly assists with safe, reliable and natural birth control.”
The Lady-Comp, 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, for either of these devices, an approved application for premarket approval (PMA) in effect pursuant to Section 515(a) of the Act, 21 U.S.C. 360(a), or an approved application for an investigational device exemption (IDE) under Section 520(g) of the Act, 21 U.S.C. 360j(g).
In addition, Lady-Comp USATM 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 USATM is an FDA approved fertility monitor.” 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 Lady-Comp USA and RaXMedical, Inc. 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 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 submit a written response to this letter within 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 direct your response to Paul Tilton at the Food and Drug Administration, 10903 New Hampshire Ave., WO66-3540, Silver Spring, MD 20993, facsimile at (301) 847-8137. We remind you that only written communications are considered official.
The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for Lady-Comp, Baby-Comp, and Pearly fertility monitors comply with each applicable requirement of the Act and FDA implementing regulations.
Sincerely yours,
/S/
Steven D. Silverman
Director
Office of Compliance
Center for Devices and
Radiological Health
-
No comments:
Post a Comment