• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

Drug Delivery Business

  • Clinical Trials
  • Research & Development
  • Drug-Device Combinations
  • FDA
  • Pharmaceuticals
  • Policy

Repro-Med clears FDA warning letter, shuffles C-suite

November 27, 2017 By Brad Perriello

Repro-Med SystemsRepro-Med Systems (OTC:REPR) said last week that the FDA cleared a 2016 warning letter for its Freedom 60 syringe infusion pump and Freedom Edge infusion pump and made some changes in the executive suite.

Repro-Med, which does business as RMS Medical Products, said the closure of the warning letter stemmed from its successful bid for 510(k) clearance for its Integrated Catch-Up Freedom Syringe Driver System, granted in September.

“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,” CEO Andy Sealfon said in prepared remarks.

RMS also said that COO Eric Bauer is slated to step down Nov. 17 for another job, but pledged to help with the transition. The company is also mounting a search to replace Sealfon after a strategic review, pending his retirement.

“Finally, in an effort to prepare the company for anticipated growth, the board of directors has committed to strengthening its membership and governance in coming months,” RMS said.

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA) Tagged With: Repro-Med Systems Inc.

IN CASE YOU MISSED IT

  • Glucotrack to effect a reverse stock split
  • Medtronic unveils ‘MiniMed’ as name for soon-to-be separated Diabetes unit
  • Insulet, Marvel collab to unveil comic book hero with type 1 diabetes
  • Insulet rolls out new Omnipod 5 iPhone app for use with Dexcom G7
  • Tandem, Abbott strike deal to pair insulin pumps with glucose-ketone monitor

Primary Sidebar

“ddb
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in drug delivery.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Footer

Drug Delivery Business News Logo

MassDevice Medical NETWORK

MassDevice
DeviceTalks
Medical Tubing + Extrusion
Medical Design & Outsourcing
MedTech100 Index
Drug Discovery & Development
Pharmaceutical Processing World
Medical Design Sourcing
R&D World

DRUG DELIVERY BUSINESS NEWS

Subscribe to Drug Delivery’s E-Newsletter
Advertise with us
About
Contact us
Privacy
Listen to our Weekly Podcasts

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy | RSS