Authored by Brian Nissen, QTS Principal Project Engineer
On October 26, 2002, the Medical Device User Fee and Modernization Act (MDUFMA) became law in the United States. While the act was primarily aimed at amending laws pertaining to fees charged to medical device manufacturers for applications, submissions and reports, it also contained verbiage regarding electronic distribution of labeling information.
Section 352(f) of title 21 of the United States Code is a whopping 711 pages! Page 144 of the document contains the following:
“Required labeling for prescription devices intended for use in health care facilities may be made available solely by electronic means provided that the labeling complies with all applicable requirements of law and, that the manufacturer affords health care facilities the opportunity to request the labeling in paper form, and after such request, promptly provides the health care facility the requested information without additional cost.”
In 2002 this particular element of the federal law was quite forward-thinking for the US government. Keep in mind, the internet was new to many citizens, dial-up internet connections were still common in households, and smartphones and tablets were years from being released. Now that internet access is no longer a luxury, more attention is being given to the electronic labeling element of this law. Wide-spread internet access and data portability, combined with environmental and financial implications, has triggered an interest in electronically delivering instructions for use (IFU) instead of providing a printed copy with every device.
QTS and our customers have been exploring implementation of e-labeling, specifically in regards to the definition of “Health Care Facility”. It appears that the term “Health Care Facility” is not explicitly defined in title 21 of the United States Code, nor is it explicitly included in title 21 of the Code of Federal Regulations. Instead, communications provided from FDA’s Center for Devices and Radiological Health indicate that the equivalent definition would be “Device User Facility” as included in 21 CFR 803, which is as follows:
“Device user facility means a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility as defined in this section, which is not a physician’s office, as defined in this section. School nurse offices and employee health units are not device user facilities.”
Bottom Line for Medical Device Manufacturers
If your product is a prescription device, and it is intended to be used in a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility – you may be eligible to switch to electronic delivery of your IFU for United States customers. However, if your device is intended for use in another type of facility, such as a physician or dental office, you may have to hold off on converting to an e-labeling system.
When considering a change to product labeling, QTS recommends that manufacturers consult their regulatory professionals and consider the needs of their customers prior to implementation.
If you have a specific question or may be looking for more details on medical outsourcing or medical device labeling, please email us at expert@qtspackage.com.