-NWRA Staff
May 25, 2022

NWRA’s Healthcare Waste Institute Comments on FDA’s Proposed Rule for Medical Devices

Arlington, VA – The Healthcare Waste Institute (HWI) of the National Waste & Recycling Association (NWRA) submitted comments to the U.S. Food and Drug Administration (FDA) on its proposed rule, Medical Devices; Quality System Regulation Amendments. HWI supports the proposed rule and offers proposed changes.

“HWI agrees with the FDA that it will be beneficial to harmonize the current quality management system requirements,” said NWRA President and CEO Darrell Smith. “We appreciate the opportunity to comment on the proposed rule.”

Proposed changes include:

Amend effective date. HWI believes it will take small domestic companies longer than one year to come into compliance with the new standards. HWI recommends that the final rule should be effective two years after publication.

Reconsider sharps disposal container regulation. If the FDA decides to maintain sharps disposal containers as medical devices, we recommend that the FDA reclassify them from Class II to Class I, given their relatively low risk of transmitting infection.


The National Waste & Recycling Association (NWRA) represents the private sector waste and recycling services industry. Association members conduct business in all 50 states and include companies that manage waste, recycling and medical waste, equipment manufacturers and distributors, and a variety of other service providers. For more information about NWRA, please visit www.wasterecycling.org.

Brandon Wright
National Waste and Recycling Association