US guidance on identification of reprocessed devices
This article was originally published in RAJ Devices
Executive Summary
The US Food and Drug Administration (FDA) has published guidance for reprocessors of single-use devices (SUDs) on how to comply with the requirement under the Medical Device User Fee and Modernization Act 2002 (MDUFMA), as amended, to prominently and conspicuously display their mark on reprocessed devices. The requirement becomes effective on 1 August 2006.
MDUFMA amended section 502 of the Food, Drug, and Cosmetic Act to require a device, or the attachment to the device, to bear “prominently and conspicuously” the name of the manufacturer, a generally recognised abbreviation of such name, or a unique and generally recognised symbol identifying the manufacturer. The Medical Device User Fee Stabilization Act of 2005 (MDUFSA), which became law on 1 August 2005, amended section 502(u) by limiting the provision to reprocessed SUDs and the manufacturers who reprocess them1,2.
Section 502(u) no longer sets forth requirements for original equipment manufacturers (OEMs), unless those manufacturers also reprocess SUDs. Under the amended provision, if the original device or an attachment to it does not prominently and conspicuously bear the name of the manufacturer of the original device, a generally recognised abbreviation of such name, or a unique and generally recognised symbol identifying the manufacturer, the manufacturer who reprocesses the SUD may identify itself using a detachable label on the device's packaging.0
The detachable label is intended to be affixed to the medical record of a patient by the user of the reprocessed SUD. The FDA therefore recommends that this label contain a statement directing the practitioner to remove the detachable label and affix it to the patient's medical record when the reprocessed SUD is used.
The guidance advises reprocessors about what constitutes “prominent and conspicuous”, giving factors such as available space, contrast, meaning and font to take into account. The guidance provides a flow chart so reprocessors can determine how they must identify themselves.
The first effective date of the requirement is 1 August 2006, which is 12 months after the date of enactment. This date applies to those reprocessed SUDs for which the OEM first marked the original device in a prominent and conspicuous manner before 1 August 2006.
The second effective date relates to compliance in those situations where the OEM first marks its device after 1 August 2006. Comments on the draft guidance (issued on 11 October 2005) had argued that if the OEM marked its device after 1 August 2006, the reprocessor of the SUD should still have 12 months from the date on which the OEM first marked the device in which to mark the reprocessed device. However, the final guidance states that the statutory language does not provide for an additional 12-month period in such cases.
References
1. Guidance for Industry and FDA Staff: Compliance with Section 301 of the Medical Device User Fee and Modernization Act of 2002, as amended - Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices, 1 May 2006
2. Federal Register, 2006, 71(83), 25594-25595