RMS Announces New FDA Clearance, Warning Letter closed, and Organizational Changes

  • Resolution of FDA Warning Letter
  • Thanks to Eric Bauer for his service as Chief Operating Officer
  • CEO search process initiated
  • BOD improvements

CHESTER, NY / November 22, 2017 / Repro Med Systems, Inc. dba RMS Medical Products (OTCQX: REPR) today announced FDA developments and organizational changes.

The FDA has officially notified RMS that the Warning Letter issued on February 26, 2016 has been closed.   This was mainly as a result of a comprehensive “Integrated Catch-Up Freedom Syringe Driver System” 510(k) K162613 which was cleared on September 1, 2017 and which not only confirmed the science behind the RMS technology but also the general and specific uses for subcutaneous (SQ) medications such as immunoglobulins and intravenous (IV) medications including antibiotics.  Andy Sealfon, CEO of RMS stated, “We are thrilled and excited that FDA has recognized the leading edge concept of a constant pressure infusion system which must include everything in the fluid path to determine the performance consistent with the FDA’s definition of Infusion Pump.”  The final chapter of closing the Warning Letter confirms that FDA has found RMS to have adequately addressed all the concerns raised in the Warning Letter.   This effort was conducted under the outstanding leadership of our Chief Medical Officer, Dr. Fred Ma.”


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