Blog Tag: Class II Device
The FDA has just released draft guidance for unique device identifiers (UDIs) tracking medical devices from their manufacturers to the end users. Specifically, the FDA is providing guidance to device the content and form of UDIs that was lacking (or at least unclear) in the original FDA UDI rule which was published on September 24, 2013.
UDI laws are currently listed under 21 CFR 801.20, and every medical device in commercial distribution is required to have a UDI, unless an exception or alternative applies (for example if the UDI is not technologically feasible). They must be given by an official UDI Issuing Agency that is in line with international standards for medical devices.
The UDI rule began applying to Class III devices in 2014 and implantable, life-supporting and life-sustaining devices in 2015. Class II devices will be in compliance this year, and Class I and non-classified devices will need to have them in 2018.
In this updated draft guidance, the FDA has clarified what forms that the UDI are required to be on medical device packaging. Specifically, the guidelines clarify that the UDIs must be present in two forms on the label and device packing: 1) “easily readable plain-text” and 2) automatic identification and data capture (AIDC) technology. The UDI then must be submitted to the Global UDI Database.
The guidelines provided further information on a number of other topics as well. For example, the guidelines clarified the AIDC technology should be read by a barcode scanner or similar technology, and the UDI may be split into multiple segments on medical device packaging. Moreover, multiple types of AIDC technology can be used on a device label, both representing the same UDI. However, if the UDI is not visible to the human eye, the packaging must disclose that there is the presence of AIDC technology.
The guidance further discussed the specific content of the UDIs, including device and product identifiers as well as data delimiters, and the particular ordering of such information on the packaging.
The FDA providing guidance to the UDI Rule is not uncommon, as a number of other guidances have been issued, such as the guidance issued on June 27, 2014 regarding the Global Unique Device Identification Database and the general guidance issued on August 20, 2014. As this is a complex and important issue, the FDA contains FAQ pages for any questions medical device manufactures may have.
The draft comments will be open for comment for 60 days, and both written and electronic comments are accepted.
Sanitas, Inc., announced today that it received approval from the United States Food and Drug Administration for its Wellaho system. According to its press release, Wellaho’s Personalized Outpatient Management System™ has been approved as a 510(K) class II medical device. The press release states that the Wellaho system is a web-based and mobile platform that allows providers a secure, HIPAA compliant tool to supervise and monitor patients with chronic conditions between office visits.
The CEO of Sanitas, Inc. states:
Patients with chronic conditions need a web of care, coming from the best that providers and technology can offer. Given the tsunami of new apps and technologies that hit the market each year, both patients and providers need the highest validation for the products and services they use. Now, with the FDA’s approval, Wellaho offers one more reason for providers and patients to trust that we can provide a safe, secure, and effective solution for managing their care.
According to the press release, the Wellaho system is currently deployed in clinical studies at UC San Diego Health Services. Sanitas, Inc.’s press release is available through PRNewswire here.