Updated September 20, 2013, at 3:30 p.m. with comments from the Medical Device Manufacturers Assn.
The FDA today issued its final rule on the long-awaiting Unique Device Identifier program, meeting with both praise and some concern form medical device makers.
The new rules addressed many of the industry’s requests, relaxing some of the labeling requirements and pushing back some deadlines, but some of the formatting decisions already have medical device groups raising eyebrows.
The UDI rule requires most medical devices to carry labels with unique codes and scannable barcodes that will allow healthcare providers, regulators and the public at large to track the devices and monitor safety. The program will assign unique codes to most medical devices and gather data to be stored in a publicly accessible database.
Medical device makers were cautiously optimistic about the news this morning, lauding some of the FDA’s revisions to the original proposal while questioning others.
"While we are still reviewing all the details of the final rule, AdvaMed commends FDA for addressing many of the concerns industry raised in the proposed rule," AdvaMed’s technology & regulatory affairs executive vice president Janet Trunzo said in prepared remarks. "We have long supported a UDI system for medical devices that, if appropriately implemented, holds the promise of more accurate and useful post-market surveillance and more rapid medical technology improvements. And this rule is a good step toward achieving that goal."
Medical device companies must also submit their identification data to a public database, called the Global Unique Device Identification Database, that the FDA says will serve as a sort of "reference catalog" for all tracked devices.
"UDI represents a landmark step in improving patient safety, modernizing our postmarket surveillance system for medical devices, and facilitating medical device innovation," FDA medical device director Dr. Jeffrey Shuren said in an agency statement. "A consistent and clear way to identify medical devices will result in more reliable data on how medical devices are used. In turn, this can promote safe device use by providers and patients as well as faster, more innovative, and less costly device development."
Global supply chain management company GHX urged medical device makers to think of the new rule "holistically" and to approach the program in search of its silver lining.
"Those that take a holistic and strategic approach to UDI can derive operational benefits, while helping their customers capture better data about the products used in patient care," GHX CEO Bruce Johnson said in an email sent to MassDevice.com. "UDI is not about just ticking a regulatory box, it is about all parties having a 360-view of the healthcare supply chain – from regulators seeking a better approach to post market surveillance, to manufacturers having control of their regulatory master data, to hospitals being able to do the kind of analytics necessary to achieve more value for our healthcare dollar."
The FDA plans to phase in the UDI program, focusing 1st on high-risk medical devices and exempting many of the low-risk ones from part or all of the requirements. In general, that means all Class III devices must carry UDI labels on their labels and on their packaging within 1 year, and data on the devices must be submitted to the global database. Most Class II devices must comply within 2 years, and any Class I devices not exempt from the rule will have 5 years to comply, according to an FDA notice. At 7 years the FDA will expect permanent markings on the devices themselves for all reusable Class I devices as well as all non-categorized devices that are still under the UDI rule.
On early review, AdvaMed analysts lauded the FDA’s decision to give medical device makers 3 years to deplete their existing inventory of non-marked devices, as well as the agency’s leniency in providing companies an avenue to petition for more time if the 1-year turnaround mark for Class I devices presents any "public health and supply" issues. The main initial concern was about the FDA’s mandate that expiration dates include both a month and a date of expiration, seeing as how most medical device testing generally doesn’t include the day of the month a device will expire.
The Medical Device Manufacturers Assn. issued a similar statement, cautiously commending the new rule.
"It appears that FDA addressed a number of issues raised by stakeholders," MDMA president & CEO Mark Leahey said in an emailed statement. "At the end of the day, both innovators and patients are best served by a cost effective and efficient UDI system."
The new rule is effective 90 days after today’s publication in the Federal Register, with the exception of a handful of rules regarding requests for extra leniency in complying with the UDI program, accreditation of issuing agencies and other points that take effect in 30 days, according to the FDA’s 160-page publication.