FDA WARNING_LETTER - Medispec, Ltd.

The FDA issued a Warning Letter to Medispec, Ltd. regarding their Radialspec? device, which is being marketed in the U.S. without required marketing clearance or approval. The FDA's Office of Compliance reviewed the company's website, www.medispec.com, and determined the Radialspec? device is a medical device under Section 201(h) of the Federal Food, Drug, and Cosmetic Act.

The device is deemed adulterated under section 501(f)(1)(B) of the Act because Medispec, Ltd. lacks an approved premarket approval (PMA) application or an approved investigational device exemption (IDE). Furthermore, the device is misbranded under section 502(o) of the Act because the company failed to notify the FDA of its intent to introduce the device into commercial distribution, as required by section 510(k).

Due to these serious violations, the Radialspec? device is subject to refusal of admission into the U.S. under section 801(a) of the Act, potentially leading to "detention without physical examination." U.S. federal agencies will be informed of this Warning Letter, which may impact future contract awards. Additionally, premarket approval applications for Class III devices will not be approved until related Quality System regulation deviations are corrected, and Certificates to Foreign Governments will be withheld.

Medispec, Ltd. must provide a