It's likely to be another seven weeks before the Food and Drug Administration finalizes long-awaited regulations that will require manufacturers to mark medical devices with unique identifiers that are expected to help track products during recalls, save money and improve patient safety.
An FDA spokeswoman said in e-mail that the final rule would not be released in time to meet the May 7 deadline that was set in legislation passed last year. “We are working hard to complete this, and it is a priority for the agency,” she said.
The FDA said in an April report (PDF)
that the agency planned to finalize the rule by June 30.
The implementation of the UDI system has been pushed back several times since it was passed into law in 2007, prompting lawmakers to include a provision in last year's user-fee legislation that required the FDA to move forward with rulemaking before the end of 2012. The FDA issued the proposed rule in July
, the same month that President Barack Obama signed the user-fee bill into law.
“Given the length of the time we've been working with the FDA and others to get the unique device identification (system) in place, having the rollout in June, while perhaps not completely ideal, is something we're very much looking forward to,” said Chantal Worzala, the American Hospital Association's director of policy.
She added that the AHA would “hate to see” further delays.
The draft rule follows a risk-based approach that would gradually roll out the standards over a seven-year period, starting with a requirement to mark the packaging of high-risk devices within a year of the final rule. The process would eventually require low-risk devices and packaging to be marked as well.
The timeframe prompted criticism from industry groups
, some complaining that it was too short and others that was too long. Hospitals and group purchasing organizations called for a faster rollout, citing patient safety concerns, while groups representing manufacturers said a one-year deadline was insufficient.
Last month, Reps. Allyson Schwartz (D-Pa.), Bill Owens (D-N.Y.) and Kurt Schrader (D-Ore.) sent a letter to FDA Commissioner Dr. Margaret Hamburg (PDF)
that raised concerns that the final rule would not be released to meet the deadline.
“As a result, patients, clinicians and hospitals will have to wait longer for improvements in post-marketing surveillance and medical device recalls,” the co-chairs of the New Democratic Coalition's healthcare task force wrote in the April 25 letter.
They also said that “lengthy delays” in the release of the final rule could prevent the CMS and the Office of the National Coordinator for Health Information Technology from issuing policies that utilize data captured by the UDI system, notably the inclusion of device tracking in the Stage 3 meaningful-use objectives. Follow Jaimy Lee on Twitter: @MHjlee