![]() ![]() ![]() Additionally, should FDA determine that you have Quality System regulation violations that are reasonably related to premarket approval applications for Class III devices, such devices will not be approved until the violations have been corrected. 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. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. Your firm should take prompt action to correct the violations addressed in this letter. The introduction or delivery for introduction of this product into interstate commerce is prohibited under section 301(a) of 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. is also misbranded under section 502(o) 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. § 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. is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. ![]() is offered for sale and distributed in the United States without marketing approval, clearance, or authorization from FDA. Our inspection, review of materials collected during the inspection, and review of your firm’s website, revealed that the Collagen P.I.N. With only 3 to 6 treatments you can achieve long-term sustainable results when supported by the Induction Therapies product line.” melasma, hyperpigmentation issues, acne scarring and rough texture just to mention a few. Per your firm’s website, “SKIN CONCERNS - Collagen P.I.N, addresses most major skin concerns Including fine lines and wrinkles, aging, sun damaged skin, peri-oral rhytides.It is also considered a valuable alternative to more invasive procedures such a laser skin resurfacing and deep chemical peeling.” Per your firm’s combined labeling, “Microneedling is deemed a safe, minimally invasive and effective esthetic treatment for multiple dermatologic conditions including acne and other scars, rhytides and striae.Per your firm’s combined labeling “Microneedling has recently been touted for a broad range of applications including skin rejuvenation, acne scarring, rhytides, surgical scars, dyschromia, melasma, enlarged pores, and transdermal drug delivery.”.Supervising Physician ultimately decides all protocols for treatments.” This device should only be used by or under the supervision of a physician. is a Class 1 FDA registered medical device for Percutaneous Collagen Induction Therapy. Per your firm’s labeling, “Collagen P.I.N.is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or intended to affect the structure or any function of the body, including: This review revealed statements that establish that the Collagen P.I.N. The agency has reviewed the product labeling for the Collagen P.I.N, including brochures, pamphlets, and your firm’s website at. § 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 intended to affect the structure or any function of the body. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. During the inspection, an FDA investigator from the United States Food and Drug Administration (FDA) determined that your firm is a manufacturer of Collagen P.I.N., a microneedling product. The United States Food and Drug Administration (FDA) conducted an inspection of your firm’s medical device operations at 3600 Chamberlain Lane, Suite 336, Louisville, KY, from June 15 – June 29, 2021. Issuing Office: Center for Devices and Radiological Health ![]()
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