WASHINGTON, DC-The US Food and Drug Administration (FDA) has announced it will extend the application deadlines for premarket approval applications for certain reprocessed "single use" devices. The federal agency will also delay enforcement of the regulations affecting hospital reprocessors.
The Association of Medical Device Reprocessors (AMDR), a Washington, DC based trade association, represents the regulatory interest of third-party reprocessors of medical devices labeled for single use only. Pamela Furman, executive director of AMDR said the decision to postpone deadline date is the right decision, whether controversial or not.
"We applaud FDA for helping our nation's hospitals find ways to contain costs without jeopardizing the health and safety of patients," she said.
The controversy surrounds the Associations of Disposable Device Manufacturers (ADDM) disappointment in the deadline extension. ADDM officials said a recent death of a boy in the United Kingdom was related to medical equipment reprocessed incorrectly. They want the deadlines and enforcement to begin promptly.
The agency has released a statement saying officials will not begin regulating premarket requirements for ablation catheters until February, 14, 2002. This is the only action exception granted by FDA concerning active enforcement of premarket approval for all reprocessed Class III devices. Third-party reprocessing of Class II and Class I devices will be phased in during the next 12 months.
For the entire FDA statement, visit: www.fda.gov/bbs/topics/ANSWERS/2001/ANS01098.html.
Information from the Association of Medical Device Reprocessors