FDA Warning Letter to MedArt A/S – Medical Device Reporting

Warning Letter addressed to MedArt A/S

“During an inspection of your firm located in Hvidovre, Denmark, on May 29, 2012, through June 1, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures medical laser devices.  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 function of the body.

 

 

Our inspection revealed that your firm’s devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 – Medical Device Reporting….”

 

 

More details can be found on the FDA website.