WARNING LETTER

Tenderneeds Fertility LLC MARCS-CMS 603383 — April 13, 2020

Product:: Medical Devices

Recipient:: Recipient Name

Nancy S. McCormick; Recipient Title

President; Tenderneeds Fertility LLC; 10162 Bradford Road
Greenville, IN 47124
United States

Issuing Office:: Division of Medical Device and Radiological Health Operations East; United States

WARNING LETTER
CMS # 603383

April 13, 2020

Dear Ms. McCormick,

The United States Food and Drug Administration (FDA) conducted an inspection of your firm’s device operations at Tenderneeds Fertility, LLC, located at 10162 Bradford Road, Greenville, IN 47124, from December 9 to 13, 2019. During the inspection, FDA investigators determined that your firm is an initial importer of devices and a manufacturer of several types of Intrauterine Insemination (IUI) and Intracervical Insemination (ICI) kits. Generally, your firm’s IUI and ICI kits include, but are not limited to, one or more devices packaged together and are intended for use during at-home insemination. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (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 to affect the structure or any function of the body.

Device Violations

Our inspection revealed that the IUI and ICI kits 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. § 360e(a), or approved applications for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g). The IUI and ICI kits are also misbranded under section 502(o) 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 CFR 807.81(b). The kind of information you need to submit in order to obtain approval or clearance for your devices is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information you submit and decide whether your products may be legally marketed.

Your IUI kits are also misbranded within the meaning of section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1), in that the labeling for the devices fail to bear adequate directions for the purposes for which they are intended, and the kits do not meet the requirements for an exemption from section 502(f)(1) of the Act under 21 CFR 801 subpart D. For example, our inspection and review of your firm’s website (https://tenderneedsfertility.com)¹ revealed that your IUI kits, including the “Ultimate Fertility At Home Insemination Kit with Sperm Wash Medium,” are intended for home use and include an assisted reproduction catheter (“insemination device with syringe”). Generic devices classified under 21 CFR 884.6110, Assisted Reproduction Catheters are class II, prescription devices that require premarket clearance (510(k)) prior to marketing. To date, we are not aware of the clearance or approval of an assisted reproduction catheter or kit containing such catheter for home use. We remind you that inclusion of a prescription device in your IUI kit renders the entire kit a prescription device. Your IUI kits, were they cleared or approved, would be required to be sold as prescription devices and, therefore, must also comply with the requirements in 21 CFR 801.109.

21 CFR 801.109 requires that your IUI kits, as prescription devices, be “sold only to or on the prescription or other order of such practitioner for use in the course of his professional practice” [21 CFR 801.109(a)(2)]; the label of each IUI kit must bear the symbol statement (i.e.,"Rx only" or "[rx] only") or “Caution: Federal law restricts this device to sale by or on the order of a _____”, the blank to be filled with the word “physician”, “dentist”, “veterinarian”, or with the descriptive designation of any other practitioner licensed by the law of the state in which the practitioner practices to use or order the use of the device [21 CFR 801.109(b)(1)]; and the labeling on or within each IUI kit package must bear information for use, including, but not limited to, indications, effects, routes, methods, and precautions [21 CFR 801.109(c)]. The inspection and our review of your website revealed that the IUI kits are sold on your firm’s website and elsewhere without a prescription or other order from a licensed practitioner, and the IUI kits’ labels do not include a prescription statement as described above nor does the package include information for use. Improper use of IUI kits by laypeople at home may raise serious public health and safety risks, including infections, injury to the vagina, uterine perforations, and risks if unwashed semen is delivered to the uterine cavity (e.g., severe uterine cramping/pain).

The inspection and our subsequent website review also revealed that the IUI kits and the pregnancy and ovulation tests that your firm markets are misbranded within the meaning of section 502(a)(1), 21 U.S.C. § 352(a)(1), in that the labeling for the devices is false or misleading. For example:

Your firm purchased products intended for use in animal insemination and resold the same products as device components in your firm’s IUI kits intended for use in human intrauterine insemination.

• Based on evidence collected during the inspection, your firm sold one “2 X Sterile Human Home Artificial Insemination Semen Kit” (emphasis added), an IUI kit, in December 2019. According to statements that you made during the inspection and the affidavit you signed during the inspection, you purchased the component devices included in your 2 X Sterile Human Home Artificial Insemination Semen Kits on (b)(4), where they were advertised as “(b)(4).” Based on statements that you made during the inspection, you did not inform the customer that these component devices included in the kit were only intended for use in animals. Use of the word “human” in the title of the kit may have created the misleading impression that the component devices were intended for use in humans and were appropriately manufactured for such use. In addition, human users of devices intended solely for animals may put the user at risk for infection due to microbial contamination or allergic reaction, irritation, or toxicity to cells due to inappropriate material biocompatibility.

• Although the 2 X Sterile Human Home Artificial Insemination Semen Kit referenced above was not sold on your website, we note that at numerous places on your website, you include the statement that certain individual products are “intended for human use, unlike many of our competitors whom [sic] only pass veterinarian use devices for women to use.” Including these statements in product descriptions may misleadingly suggest that you do not engage in the practice of representing that veterinarian devices are human devices. As described above, evidence collected during the inspection demonstrates that you do engage in this practice for certain products.

Your firm markets pregnancy and ovulation tests as part of certain of its IUI and ICI kits as well as individually. FDA has not approved your firm’s pregnancy or ovulation tests. Numerous representations on your firm’s website create the misleading impression of official approval of the pregnancy and ovulation tests. For example:

• The “Premium At Home Human Pro Series Insemination Kit” includes TenderNeeds “Fertility® LH Ovulation Test Strips (Qty 5)” and “TenderNeeds Fertility®HCG Pregnancy Test Strips (Qty 3)”. The product description states that “All test strips are FDA approved and over 99% accurate.”

• The “Tenderneeds Fertility HCG Pregnancy and LH Ovulation Urine Serum Combo Test Compare to First Response” description states that “All test strips are FDA approved and over 99% accurate.”

In addition, your pregnancy and ovulation tests are misbranded within the meaning of section 502(a) of the Act, 21 U.S.C. § 352(a), because you include the FDA logo on the tests’ boxes. 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 FDA favors or endorses your products, or create a misleading impression of official approval of your devices. Unauthorized use of the FDA logo may violate federal law and subject those responsible to civil and/or criminal liability.

The inspection also revealed that your devices are misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), in that the devices were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act, 21 U.S.C. § 360, and were not included in a list required by section 510(j), 21 U.S.C. § 360(j).

The inspection also revealed that your devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at 21 CFR part 820. To date, we have not received a response from you, concerning our investigators’ observations noted on the Form FDA 483, List of Inspectional Observations (FDA 483) that was issued on December 13, 2019. These violations include, but are not limited to, the following:

1. Failure to establish and maintain procedures for design control as required by 21 CFR 820.30(a).

• Your firm has no design control procedures in place to control the design of devices. From November 10 to December 10, 2019, your firm distributed (b)(4) insemination kits for home use which were not developed under any design control.