|Subject:||Lacks Premarket Approval/Adulterated|
|Issuer:||Center for Devices and Radiological Health|
|Issued:||June 10, 2005||Closed:||
Department of Health and Human Services
Public Health Service
Center for Devices and Radiological Health
JUN 10 2005
VIA FEDERAL EXPRESS
Ms. Leslie Sebastian
990 Park Center Drive-Suite E
Vista, California 92081
Dear Ms. Sebastian:
We are writing to you because the Food and Drug Administration (FDA) has learned that your firm is marketing Soothies® Gel Pads in the United States (U.S.) for use by pregnant or breastfeeding women without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321 et seq. This product is a device within the meaning of section 201(h) of the Act, 21 U.S.C. 321 (h).
The Act generally requires that manufacturers of medical devices obtain marketing clearance for their products from the FDA before they may offer them for sale. This helps protect the public health by ensuring that newly-introduced medical devices are safe and effective, or substantially equivalent to other devices that are already legally marketed in this country. Our records do not show that you obtained marketing clearance before you began offering your Soothies® Gel Pads for sale.
In some cases, breast pads have been considered to fall within FDA's classification regulation at 21 CFR 880.5630 pertaining to nipple shields intended to protect the nipples of nursing women. Devices within this classification are Class I devices and, as such, are generally exempt from section 510(k) premarket notification requirements However, marketing Soothies® Gel Pads for use by pregnant or nursing women does require the submission and prior clearance of a section 510(k) premarket notification because your product is comprised of new hydrogel materials (e.g., polyacrylamide) that are not contained in any of the existing products falling within the classification at 21 CFR 880.5630. (See 21 CFR 880.9 describing limitations on exemption from premarket notification requirements). FDA has not yet had an opportunity to review how exposure to these new materials may affect nursing mothers and their infants
The kind of information you need to submit in order to obtain prernarket clearance is described on FDA's device web site at www.fda.gov/cdrh/devadvice . FDA will evaluate this information and decide whether your product may be legally marketed.
Because you do not have marketing clearance from the FDA, marketing your product is a violation of the law. In legal terms, the product is misbranded under section 502(o) of the Act and adulterated under section 501(f)(1)(B) of the Act. Your product is misbranded under the Act because you did not submit a section 510(k) premarket notification that shows your device is substantially equivalent to other devices that are legally marketed. Until you submit a section 510(k) premarket notification and FDA reviews it and notifies you that you may market your device, your product is also adulterated under the Act because the law requires, and you do not have, an approved premarket approval application that shows your device is safe and effective. For a product requiring premarket approval before marketing, the notification required by section 510(k) is deemed to be satisfied when a PMA is pending before the agency. 21 CFR 807.81(b).
You should know that this serious violation of the law may result in FDA taking regulatory action without further notice to you. These actions include, but are not limited to, seizing your product inventory, obtaining a court injunction against further marketing of the product, or assessing civil money penalties. Also, Federal agencies are informed about the Warning Letters we issue, such as this one, so that they may consider this information when awarding government contracts.
It is necessary to take action on this matter now. 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 problem from happening again. If you need more time, let us know why and when you expect to complete your correction.
Please direct your response to Ms. Carolyn Niebauer, Chief, General Hospital Devices Branch, HFZ-333, Center for Devices and Radiological Health, 2094 Gaither Road, Rockville, MD 20850.
You should understand that there are many FDA requirements pertaining to the manufacture and marketing of medical devices. This letter pertains only to the issue of premarket clearance for your device and does not necessarily address other obligations you may have under the law. You may obtain general information about all of FDA's requirements for manufacturers of medical devices by contacting our Division of Small Manufacturers, International and Consumer Assistance at (800) 638-2041, or through the internet at http://www.fda.gov.
If you have any questions about the contents of this letter, please contact Ms. Carolyn Niebauer at 240-276-0115 or by facsimile 240-276-0114.
Timothy A. Ulatowski
Office of Compliance
Center for Devices and Radiological Health