NWRA, Healthcare Waste Institute propose changes to FDA’s rule on medical devices

The Healthcare Waste Institute (HWI) of the National Waste & Recycling Association (NWRA), Arlington, Virginia, has voiced its support for a new proposal on medical devices by the Food & Drug Administration (FDA). The proposal would amend the agency’s device quality requirements to align closer with the international consensus standard for medical device manufacturers (ISO 13485:2016).

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

However, both organizations have proposed changes to the rule. The changes include extending the time it takes for manufacturers and companies to adhere to the new standards.

HWI says it believes it will take small domestic companies longer than one year to comply with the new standards as they are unfamiliar with them. Instead, HWI recommends that the final rule should be effective two years after publication.

The organizations are also advocating for a class change on sharps disposal containers. The two say there are no regulatory standards for sharps disposal containers in the current federal Food, Drug, and Cosmetic Act. The organizations added that the standards are not included in ISO 13485 either because the European Union does not consider sharps disposal containers to be medical devices. The two organizations suggest removing any requirements that would subject sharps disposal containers to the amended Part 820 regulations.

The two say if the FDA decides to maintain sharps disposal containers as medical devices, it should reclassify them from Class II to Class I. This is because of their relatively low risk of transmitting infection.