Medical Devices Law & Industry Report provides complete in-depth, interdisciplinary news coverage of all major developments in the rapidly changing medical...
A group of House Democrats in an April 25 letter questioned whether the Food and Drug Administration will be able to finalize its rule establishing a unique device identification (UDI) system by the statutory deadline.
The letter was signed by the co-chairs of the New Democrat Health Care Task Force--Reps. Allyson Schwartz (D-Pa.), Kurt Schrader (D-Ore.), and Bill Owens (D-N.Y.). The lawmakers said they were concerned about “recent public comments from FDA officials” that suggest the agency will not finalize the regulations by the May 7 statutory deadline.
Congress first required FDA to establish a UDI system in a 2007 law, but did not set a deadline for FDA to issue a regulation. The Food and Drug Administration Safety and Innovation Act (FDASIA), signed in July 2012, established a schedule for issuing a proposed and final UDI rule. FDA issued the proposed rule that month (6 MELR 442, 7/11/12).
“While FDA met its first FDASIA deadline [for a proposal], the agency--based on public comments--appears poised to miss the May deadline for the rule's finalization,” the Democrats said.
A UDI is a unique numeric or alphanumeric code that includes a device identifier, which is specific to a device model, and a production identifier, which includes the current production information for that specific device, such as the lot or batch number, the serial number, and/or expiration date.
FDA said it is proposing a risk-based, phased-in approach to UDI implementation, focusing on the highest-risk devices first and exempting low-risk devices from some or all of the requirements. FDA will begin to issue UDI tracking mandates for devices in 2014 and plans for the UDI system to be fully implemented for all high-risk devices by 2021.
FDA said that when fully implemented, UDI will enhance postmarket surveillance by improving the quality of information in medical device adverse event reports, which will help the FDA identify product problems more quickly, and better target which devices may be subject to recalls.
FDA on April 23 released a report on strengthening postmarket surveillance that includes finalizing the unique device identifier rule (see related item).
The lawmakers said, “The benefits of a UDI system can only be achievable after the FDA releases a UDI final rule … we urge the FDA to meet the statutory deadline for finalizing the UDI rule, which will enhance medical device tracking, and ultimately, improve patient care.”
By Nathaniel Weixel
The letter is at http://op.bna.com/hl.nsf/r?Open=nwel-975rgk.
All Bloomberg BNA treatises are available on standing order, which ensures you will always receive the most current edition of the book or supplement of the title you have ordered from Bloomberg BNA’s book division. As soon as a new supplement or edition is published (usually annually) for a title you’ve previously purchased and requested to be placed on standing order, we’ll ship it to you to review for 30 days without any obligation. During this period, you can either (a) honor the invoice and receive a 5% discount (in addition to any other discounts you may qualify for) off the then-current price of the update, plus shipping and handling or (b) return the book(s), in which case, your invoice will be cancelled upon receipt of the book(s). Call us for a prepaid UPS label for your return. It’s as simple and easy as that. Most importantly, standing orders mean you will never have to worry about the timeliness of the information you’re relying on. And, you may discontinue standing orders at any time by contacting us at 1.800.960.1220 or by sending an email to firstname.lastname@example.org.
Put me on standing order at a 5% discount off list price of all future updates, in addition to any other discounts I may quality for. (Returnable within 30 days.)
Notify me when updates are available (No standing order will be created).
This Bloomberg BNA report is available on standing order, which ensures you will all receive the latest edition. This report is updated annually and we will send you the latest edition once it has been published. By signing up for standing order you will never have to worry about the timeliness of the information you need. And, you may discontinue standing orders at any time by contacting us at 1.800.372.1033, option 5, or by sending us an email to email@example.com.
Put me on standing order
Notify me when new releases are available (no standing order will be created)