The Medical Device User Fee Amendments of 2018 and Why It Matters for SUD Reprocessing

The Medical Device User Fee Amendments of 2018 and Why It Matters for SUD Reprocessing

 

  1. Reprocessing Extends the Value of Medical Devices that Hospitals Already Own. In today’s Federal Register Notice, pursuant to MDUFA IV, FDA released the fees for manufacturers and reprocessors for their annual registrations and device-specific applications.  Reprocessors, just like all other medical device manufacturers, must pay these fees.  AMDR congratulates the Congress on reauthorizing this program and looks forward to continuing to meet the agency’s safety and efficacy expectations, while extending the value of the medical devices hospitals already own as a means to reduce healthcare costs and waste.

 

  1. The Newly Passed Legislation Continues the Long-Standing FDA Funding Mechanism for Medical Devices, including Lower-Cost Reprocessed Single-Use Devices (SUDs).   On August 18, President Trump signed into law the Medical Device User Fee Amendments of 2018, or MDUFA IV.  This authorizing legislation, the fourth iteration of the FDA user fee program, continues the now long-standing FDA funding mechanism to help speed to market medical devices, including lower-cost reprocessed single-use devices (SUDs).

 

  1. A Manufacturing Activity, FDA Regulation Recognizes that Reprocessed SUDs as Safe and Effective as any other Medical Device. Since 2000, FDA has regulated the reuse of SUDs as a manufacturing activity, and it was in the initial Medical Device User Fee and Modernization Act (MDUFMA) legislation of 2002 that Congress codified manufacturer treatment for SUD reprocessors.  It is also in the original legislation that Congress added specific additional regulatory requirements including labeling, the removal of certain exemptions for reprocessed versions of devices, and certain validation data requirements for reprocessors.  FDA’s actions in 2000, the passage of MDUFMA on 2002 and the subsequent reauthorizations have cemented FDA’s treatment of SUD reprocessing as a manufacturing activity, subject to all FDA requirements.  In fact, reprocessors are, in many regards, required to meet certain requirements not in place for original equipment manufacturers.  Thus, patients, healthcare providers and others have known that a reprocessed SUD will be as safe and as effective as any other medical device.
By | 2017-08-29T18:20:06+00:00 August 28th, 2017|Blog|0 Comments