News: Reconditioned Devices: Potential Regulatory Changes Create Tension Between Third-Party Entities, OEMs
Peter Ohanian of the Halloran Consulting Group highlights potential regulatory changes in the US that could affect medical device refurbishers
Friday, 23rd December 2016
In an article for Med Device Online, Peter Ohanian discusses recent activity in the US medical device sector that could bring major changes to the refurbished medical device market.
A request for comment by the FDA seeking industry feedback on refurbished medical devices was released in March 2016 and closed in June. Should evidence of quality and public health issues be identified, the FDA may strengthen regulation in the area, for example by reviewing the exemption for the industry of Quality System Regulation requirements under CFR part 820.
Another factor noted by Ohanian is the huge projected growth in the industry (projected to reach $11.9 billion by 2021), creating a competitive atmosphere between OEMs and third-parties.
The full article can be found at the external link below.