Coloplast offers the only FDA approved testicular implant on the market today.
About the FDA and Medical Devices
With respect to medical devices, the FDA's primary role is "ensuring that medical devices are reasonable, safe, and effective." As a regulatory body, the FDA approves devices through its Center for Devices and Radiologic Health (CDRH), which oversees clinical testing, materials quality, marketing, labeling, and classification, among other areas. CDRH is responsible for regulating companies who manufacture, repackage, relabel, and/or import medical devices sold in the United States.
Medical devices are categorized by class (Class I, II, and III), depending on their complexity and the invasiveness of their use. Regulatory control increases from Class I to Class III. The device classification regulation defines the regulatory requirements for a general device type. Coloplast testicular implants are considered a Class I device, meaning the device is considered minimally-invasive.
Why does FDA approve medical devices before they can be sold?
Before granting approval to manufacturers to sell their new devices, FDA science experts review the manufacturer’s data from investigational studies to see if:
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the product does what it claims to do effectively, and
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does not present any unreasonable risks to the patient.
Where can I find more information about the FDA's approval of Coloplast testicular implants?
One accurate source of information about the risks and benefits of the product is patient labeling prepared by the manufacturer and reviewed by the FDA. An approval overview document for Coloplast testicular implants is available on the FDA's Recently Approved Devices page. View it here.
Note: Coloplast testicular implants are listed as "Mentor Saline-Filled Testicular Prosthesis."
Source: CDRH
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