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FDA goes after California stem cell doc for unapproved breast implant device
The FDA this week sent a warning letter to a Beverly Hills, Calif.-based surgeon for their marketing of an unapproved implantable device, dubbed the Pocket Protector, which the surgeon claims can prevent and treat capsular contracture, or scar tissue tightening, during breast implant procedures. In its letter, the federal watchdog also accuses the surgeon, Dr. Mark Berman, of “significant deviations from the FDA’s quality system requirements and current good manufacturing practices,” including charges related to the sterility of implantable devices. “This is not the first time the FDA has notified D...
Source: Mass Device - February 15, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cosmetic/Aesthetic Featured Food & Drug Administration (FDA) Stem Cells Source Type: news

FDA Lays the Smackdown on Illegal Stem Cell Clinics
FDA is cracking down on stem cell clinics that market unapproved products and don't meet good manufacturing practice requirements. On behalf of the agency, the Department of Justice filed two complaints in federal court this week seeking permanent injunctions against a Florida-based clinic and a California-based clinic.  “Cell-based regenerative medicine holds significant medical opportunity, but we’ve also seen some bad actors leverage the scientific promise of this field to peddle unapproved treatments that put patients’ health at risk. In some instances, patients have suffered serious and permanent harm after re...
Source: MDDI - May 10, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance Source Type: news