- Delivery Method:
- Via Email
- Medical Devices
Recipient NameMarylin Dans
- Silkprousa LLC
3257 NW 7th Ave CIR
Miami, FL 33127
- Issuing Office:
RE: CMS Case #608493
Dear Marilyn Dans:
The United States Food and Drug Administration (FDA) has learned that your firm is marketing Pink Luminous Breast, a transilluminator for breast evaluation, in the United States 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), this product 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 to affect the structure or any function of the body.
FDA has reviewed the labeling on the package of your Pink Luminous Breast device and your firm’s website and determined that the device is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does 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 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 your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). Specifically, labeling on the package of your Pink Luminous Breast device includes statements such as: “…easy to use FDA registered medical screening tool designed to give women a never-before-possible look at the inner workings of their breasts…” and “Tiny fractions of light pass through the breast to reveal dark clusters that may indicate potential abnormalities of lumps.” Package labeling also includes use of FDA’s logo. Your website includes claims such as: “Pink Luminous Breast can be a powerful tool in detecting potentially harmful tissue and masses inside your breasts” and “Using RED LED light technology, Pink Luminous Breast will illuminate the tissue inside your breasts, giving you an understanding of what is happening on the inside.” Additionally, on your website you claim: “The Pink Luminous Breast is FDA approved and cleared for safety.” A search on the FDA’s public registration and listing page did not return any results for your firm or devices.
Based upon the labeling on the package of your device, statements on your website and how the device functions, your device is a breast transilluminator for visualizing translucent tissue for the diagnosis of cancer, other conditions, diseases, or abnormalities. Breast transilluminators have been classified as class III devices regulated under 21 CFR 892.1990 and require approval of a PMA prior to marketing.
Your device is also misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because your labeling on the package of your device and your website uses the FDA logo. The FDA logo is for the official use of the FDA and not for use on private sector materials. Such use may send a misleading message that the FDA favors or endorses your product. Unauthorized use of the FDA logo may violate federal law and subject those responsible to civil and/or criminal liability.
For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency. [21 C.F.R. 807.81(b)] The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is available through the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether your product may be legally marketed.
Given the serious nature of the violations of the Act, Pink Luminous Breast devices are subject to refusal of admission under section 801(a) of the Act, 21 U.S.C. § 381(a), in that they appear to be adulterated. As a result, FDA is taking steps to refuse entry of these devices into the United States, known as “detention without physical examination,” until these violations are corrected. In order to remove the devices from detention, your firm should provide a written response to this letter as described below and correct the violations described in this letter.
Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of 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 notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, including an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within thirty business days, state the reason for the delay and the time within which these activities will be completed. Please provide a translation of documentation not in English to facilitate our review. We will notify you regarding the adequacy of your firm’s response(s) and the need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made.
Your firm’s response should be sent via email to CDRHWarningLetterResponses@fda.hhs.gov. Refer to the Unique Identification Number CMS case #608493 when replying. If you have any questions about the contents of this letter, please contact: Erin McFiren, Reviewer at +1-301-796-0535 or Erin.McFiren@fda.hhs.gov.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.
Robert Ochs, PhD
Deputy Director for Radiological Health
OHT7: Office of In Vitro Diagnostics and Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health