Medical Device Link.

Originally Published IVD Technology May 2003

INDUSTRY NEWS

Jennifer Zakroff

The Office of In Vitro Diagnostic Device Evaluation & Safety (OIVD) and the Office of Device Evaluation (ODE) recently defined their responsibilities and expectations of medical device manufacturers with regard to Section 206 of the Medical Device User Fee and Modernization Act (MDUFMA). This portion of MDUFMA updates FDA’s long-standing requirement that labeling for devices be provided to purchasers in a paper form. Section 206 takes technological advances into account and allows companies to provide information about their devices in electronic “paperless” form. 

Section 206 of MDUFMA has amended Section 502 of the Federal Food, Drug, and Cosmetic Act to authorize the use of electronic labeling under specified circumstances. Upon enactment, distributors of prescription devices intended for use within the confines of a healthcare facility may provide labeling for those devices solely in electronic form. They must, however, provide labeling to users in a paper form, upon request.

Although manufacturers are required to provide a hard copy of their labeling for all premarket reviews, reviewers may now request an electronic version, if an electronic version will be used on the market. Thus, manufacturers that intend to use electronic labeling should have both electronic and paper copies available for review. 

ODE and OIVD are preparing to receive more devices that are configured to directly interface with or even incorporate personal computers with Internet access. 

For eligible devices that are the subject of approved premarket approval (PMA) applications, the offices have announced that paper labeling may be transferred to an electronic format and distributed to healthcare facilities without the approval of PMA supplements. When a PMA holder makes such a labeling change, it should notify FDA of the change in the company’s next annual report to the agency.

ODE/OIVD encourages manufacturers of new devices or existing devices that have undergone substantial changes and will be sent to ODE/ OIVD for review to provide proposed labeling to the offices in the same form that it will be provided to healthcare facilities. Submissions for devices that qualify for electronic labeling should therefore include a copy of the electronic label presented as a separate computer disk (e.g., CD-ROM) or as reference to the device manufacturer’s Web site, where the reviewer can access the labeling.

Detailed information regarding electronic submissions sent to ODE/OIVD can be accessed on the Internet at http://www.fda.gov/cdrh/elecsub.html. 

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