Section 206 of the Medical Device User Fee and Modernization

Detailed Analysis

False Claims and Regulatory Violations

The FDA identified regulatory violations in Section 206 of the Medical Device User Fee and Modernization Act (MDUFMA) (New section 502(f) of the Federal Food, Drug, and Cosmetic Act) Electronic Labeling for Prescription Devices Intended for Use in Health Care Facilities - #G03-1's operations or product claims.

Potential Health Risks

Subject:Section 206 of the Medical Device User Fee and Modernization Act (MDUFMA) (New section 502(f) of the Federal Food, Drug, and Cosmetic Act) Electronic Labeling for Prescription Devices Intended for Use in Health Care Facilities

Section 206 of MDUFMA amended Section 502(f) of the Federal Food, Drug, and Cosmetic Act (the Act) to authorize the use of electronic labeling, rather than the traditional paper labeling, under specified circumstances. Upon enactment, distributors ofprescription deviceswho intend those devices to be used within the confines of ahealth care facilitymay provide labeling for those devices solely in electronic form, so long as they afford users the opportunity to request the labeling in paper form and promptly provide such labeling to requestors without additional cost.

The new provision of the law also addresses the concern that consumers without access to personal computers and the Internet would suddenly find themselves with devices and no readily available instructions for their use. Because Congress concluded that the greatest risk for this occurring was in the home, Section 206 stipulated that prescription (Rx) devices intended for use in health care facilities are the only devices that fall within the scope of the provision. By limiting the impact of the provision to Rx devices intended for use in health care facilities, it was understood that over-the-counter (OTC) devices would not be affected; neither would Rx devices intended for home use.1To address the concern that there may be health care facilities, such as physician’s offices or small clin

Regulatory Context

The purpose of this Blue Book Memorandum is to outline the responsibilities of the Office of Device Evaluation/ Office of In Vitro Diagnostic Device Evaluation & Safety (ODE/OIVD) in the proper implementation of Section 206 of MDUFMA and to provide instructions for fulfilling those responsibilities.

It is important to recognize that FDA contributed to the language appearing in Section 206 of MDUFMA and was a strong advocate for updating the statute to reflect the progress that has transpired with information technology. Anticipating a likely continuation of this technology revolution, the new provision uses the term “electronic labeling,” rather than specifying computer discs, computer diskettes, computer hard drives, or the Internet. This was done to ensure that the law allows for future change, as information technology progresses beyond what is known today.

Lastly, Section 206 of MDUFMA does not exempt electronic labeling from any legal requirements that apply to device labeling in general. Manufacturers electing to provide electronic labeling must ensure that it is not false or misleading in any particular and are expected to meet all other applicable regulatory requirements, such as those contained in 21 CFRParts 801and809.