- Medical Devices
Recipient NameHuaquan Yu
- Shenzhen Weifa Technology Co., Ltd
Room 403, Building 117, Sungang Village, Baogang Road, Sungang Street
Guangdong Sheng, 518100
- Issuing Office:
- Center for Devices and Radiological Health
DATE: March 11, 2021
Re: FFP1 3-ply Non-Woven EarLoop Mask and N95/FFP2 Respirator
Dear Huaquan Yu:
This is to advise you that the United States Food and Drug Administration (FDA) has reviewed your website at the Internet address www.starkit.com, on February 2, 2021, where you offered the “FFP1 3-ply Non-Woven EarLoop Mask” and “N95/FFP2 Respirator” for sale in the United States. Based on our review, 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 to affect the structure or any function of the body, and thus, are devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the “Act”), 21 U.S.C. § 321(h).
The FFP1 3-ply Non-Woven EarLoop Mask and the N95/FFP2 Respirator1 are being offered for sale in the United States without marketing approval, clearance, or authorization from FDA. Accordingly, these products are 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 (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g). These products are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).
In addition, the FFP1 3-ply Non-Woven EarLoop Mask and N95/FFP2 Respirator are misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because their labeling is false or misleading. The devices are not “FDA certificated” and so express statements to the contrary are false. Moreover, FDA registration of a device establishment or assignment of a registration number does not denote FDA approval of the establishment or the device. Thus, references to your firm’s establishment registration and registration number that create an impression of official FDA approval, clearance, authorization, certification, endorsement or other evaluation of the establishment or the N95/FFP2 Respirator are misleading and constitute misbranding. See 21 CFR 807.39.
Your website contains a number of false and/or misleading representations, including but not limited to:
• Stating that the devices are “FDA certificated” and that the devices are “official certificated…FDA.”
• Unauthorized display of FDA’s logo2 alongside the devices’ product information.
• Displaying a “Certification of FDA Registration” (Certification) issued by “Shenzhen CCT Testing Technology Co. Ltd.” alongside N95/FFP2 Respirator product information. The Certification “certifies that Shenzhen Weifa Technology Co., Ltd … has completed the FDA Establishment Registration and Device Listing with the US Food & Drug Administration…” and incorporates, unauthorized use of the FDA logo2.
To date, FDA has not “certificated” the FFP1 3-ply Non-Woven EarLoop Mask and the N95/FFP2 Respirators, and statements to the contrary are false. In addition, taken together, display of the FDA logo and Certification positioned near images of and information about the N95/FFP2 Respirator are misleading because they imply FDA approval, clearance, authorization, certification, endorsement, or other evaluation of the N95/FFP2 Respirator and/or establishment based on the existence of your firm’s registration and possession of a registration number. Although the Certification contains language that appears to be intended to function as a disclaimer, including a statement that the Certification does not denote FDA endorsement or approval, statements that FDA does not issue or recognize certificates of registration, and a statement that quotes 21 CFR 807.39, the small font size and overall placement of the language could be easily overlooked and do not limit or otherwise mitigate the misleading impression created by the use of the Certification. Such representations are especially concerning from a public health perspective because consumers rely on information provided by sellers to determine whether to purchase a device and your presentation conveys the misimpression that the N95/FFP2 Respirator has been reviewed and approved by FDA.
We remind you that FDA’s Center for Devices and Radiological Health (CDRH) does not issue any type of device registration certificates to medical device establishments, including sellers and manufacturers. When an establishment registers and lists its devices, the resulting entry in FDA’s Establishment Registration & Device Listing Database does not denote anything other than that the establishment has provided certain information to FDA.
This letter is not meant to be an all-inclusive list of violations that exist in connection with the product or your operations. It is your responsibility to ensure that the products you sell are in compliance with the Act and its implementing regulations. We advise you to review your website, product labels, and other labeling and promotional materials to ensure that you do not make representations that misbrand the product(s) in violation of the Act.
This letter notifies you of our concerns and provides you with an opportunity to address them.
Please notify this office in writing within fifteen 15 business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of any 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. Your firm’s response should be comprehensive and address all violations included in this letter. If you believe that the products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
If you are not located in the United States, please note that products that appear to be adulterated or misbranded may be detained or refused admission if they are offered for importation into the United States. We may advise the appropriate regulatory officials in the country from which you operate that FDA considers your products listed above to be adulterated and misbranded products that cannot be legally sold to consumers in the United States.
Your firm’s response should be sent via email to CDRHWarningLetterResponses@fda.hhs.gov or by mail to:
Food and Drug Administration
Center for Devices and Radiological Health
Office of Regulatory Programs
Division of Regulatory Programs 2: Establishment Support
Regulatory Inspections and Audits Team
White Oak Building 66
10903 New Hampshire Ave.
Silver Spring, MD 20993
Refer to the Document number CMS Case# 609828 or CTS Number CPT2000946 when replying. We remind you that only written communication is considered as official.
If you have any questions about the contents of this letter, please contact: Assistant Director, Paola Barnett at 301-796-5462 or Paola.Barnett@fda.hhs.gov.
Donna Engleman, MS, BSN
Director Division of Market Intelligence
Office of Regulatory Programs
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
4402 Gertrude Dr
Fremont, CA 94536 firstname.lastname@example.org
Shenzhen CCT Testing Technology Co. Ltd.
6F, Fazhan Building, No.04, Shangwu Road,
Shiyan Town, Bao'an District, Shenzhen, Guangdong, 518108 China
Gaomishi Zhonghexiang Labor Products Industry & Trade Company
2th.Zhilan Village, Chaoyang District, Gaomi City,
Shandong Province, Weifang Shandong, CN 261500
Medical Facility Company
555 Lexington Avenue
Fort George, NY 10040
1 Your website indicates the N95/FFP2 Respirator is manufactured by “Gaomishi Zhonghexiang labor products industry &Trade Co., Ltd.”
2 The FDA logo is for official use by FDA and not for private use on labeling of FDA-regulated products. See FDA Logo Policy (available at: https://www.fda.gov/about-fda/website-policies/fda-logo-policy).