With an aging population and obesity concerns in the U.S. population overall, diabetes is on the rise. The FDA estimates that millions of people use glucose meters every day. In order to provide greater clarity regarding the differences in monitoring in a clinical setting as opposed to at-home use, the FDA has just issued two new draft guidance documents on Blood Glucose Monitoring Systems. This provides insight into the differences the FDA finds in those systems used in professional healthcare systems and those used by the population in general.
Both guidance documents were issued in response to concerns over infection control. And for the first type of device, Self-Monitoring Blood Glucose (SMBG) systems, the issue of proper cleaning throughout the life of the device is a critical concern. If you’re a producer of such a monitor, the document “Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use – Draft Guidance for Industry and Food and Drug Administration Staff” has information for you.
It recommends design and labeling considerations to reduce the risk of bloodborne pathogen transmission. It includes specific information that you’ll need to include in your 501(k) submittal as well. And it gives you the FDA performance evaluation and criteria your device will be expected to meet.
This is a detailed document, covering software, test strip lot release criteria, flex studies and more. There’s even a list of likely sources of error in properly using the device that you’ll need to address in your submittal. Remember, these devices are covered by the FDA regulations for Glucose Test Systems (21 CFR 862.1345), so the more you know about the acceptance process, the better.
Our second draft guidance, “Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use – Draft Guidance for Industry and Food and Drug Administration Staff,” was released at the same time as the first. We’ll use the FDA convention and call these devices that are used in healthcare environments (like hospitals and nursing homes) BGMSs, for Blood Glucose Monitoring Systems. Again the concern is infection control and the cleaning requirements needed to avoid the spread of bloodborne pathogens.
This draft guidance covers the professional setting because the affected patients in these environments have more critical health issues. For example, one major difference is that a glucose monitor in a professional setting may be used by more than 1 person, whereas a home kit is intended for 1 patient only. So careful instructions on cleaning, as well as a robust design for ease of use and disinfection, are essential.
Again, the new document addresses the information you need to include in your 501(k) submission. You’ll want to be aware that the FDA does state that the criteria in ISO 15197, “In vitro diagnostic test systems – Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus,” are not adequate for this type of device. So close attention should be paid to the various testing and design requirements put forth in this guidance.
This too is a detailed document. If you produce blood glucose monitors, you’ll want to review these new documents asap. You’ll have 90 days from the date of the documents (1/7/2014) to comment. There is information on the cover sheet of each on how to send in your feedback.
Here at Document Center Inc., we have many customers in the medical device arena. So keeping up with the latest FDA information is essential for us and for our clients. If you need help procuring or monitoring these types of publications, get in touch with us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). And to order any standard you need, head off to our web store www.document-center.com. We have an extensive collection of standards and other technical and regulatory information. After all, we’ve been selling standards since 1982. Make us your Standards Experts!
