Letter

Pew Comments on FDA's Unique Device Identifier Amended Proposed Rule

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Josh Rising, director of the medical device initiative at The Pew Charitable Trusts, filed comments to the Food and Drug Administration on the recent amendment to the proposed rule for a unique device identification system.

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December 19, 2012

Margaret Hamburg
Commissioner
Food and Drug Administration
Department of Health and Human Services
Room 2217
White Oak Building One
10903 New Hampshire Avenue
Silver Spring, MD 20993

RE: FDA-2011-N-0090-0222: Food and Drug Administration; Unique Device Identification System; Amendment

Dear Dr. Hamburg:

The Medical Device Initiative of The Pew Charitable Trusts welcomes the opportunity to submit supplemental comments following the recent amendment to the U.S. Food and Drug Administration’s (FDA) proposed rule for a unique device identification (UDI) system for medical devices, as required by section 226 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) and reaffirmed in Section 614 of the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA).

The Pew Charitable Trusts is an independent, non-profit organization that applies a rigorous, analytical approach to improve public policy, inform the public and stimulate civic life. The Medical Device Initiative seeks to improve the safety of medical devices and to foster innovation that benefits patients through streamlined device approvals.

We are pleased that the FDA is working toward implementing a UDI system and appreciate the opportunity to submit comments on the amendment. We offer these comments as a supplement to our November 7th submission.

Timeline for Implementation

We appreciate the work that the agency has done to revise the timeline due to the new statutory requirement from FDASIA. However, many of the comments from our November 7th submission are still applicable even with this amended schedule.

In particular, the timeline is unnecessarily lengthy. We continue to urge the FDA to modify the timeline so that every device has the UDI on the label within three years and is directly marked within four years (if it meets the appropriate criteria). We support FDA’s efforts to stage these requirements and prioritize the highest risk devices.

Direct Marking

The amendment did not indicate a change in the agency’s thinking on which devices should be directly marked. As we previously stated, we support the agency’s proposal to require direct marking of the UDI on 1) implantable devices, 2) re-sterilized devices intended to be used more than once, and 3) stand-alone software.

In addition, we would like to reiterate our recommendation that the FDA expand the direct marking requirement to include all Class II and Class III devices intended to be used more than once. The UDI labeling requirement as proposed is insufficient for the many medium and high-risk devices that are routinely separated from their packaging upon delivery to health care facilities and may be used on many patients over a lengthy time period. The FDA will not meet the public health objectives laid out in the proposed rule unless Class III and II devices used more than once are directly marked.

For example, the proposed rule states that healthcare facilities will be required to include the UDI when reporting an adverse event. For products such as infusion pumps that are separated from their labeling, it will be impossible for healthcare facilities to meet this standard unless the infusion pump has the UDI directly marked. Similarly, it may be difficult for a healthcare facility to effectively conduct a recall on a device used multiple times if the device is not directly marked. Infusion pumps have been subject to numerous Class I recalls (i.e., those that represent the greatest threat to human health) over the years and many of the current problems with conducting recalls will persist unless the devices themselves are directly marked.

Reference 13: Implantable, Life-saving and Life-sustaining Devices

We support FDA’s proposal to interpret “implantable, life-saving, and life-sustaining” as having the same meaning as “implantable, life sustaining, or life supporting,” for the purposes of consistency with Federal Food, Drug, and Cosmetic Act language. However, Reference 13, the list of medical devices by product code that FDA classifies as “implantable, life-saving and life-sustaining” devices for purposes of Section 614 of FDASIA, does not include some devices that should fall into this category. For example, infusion pumps (FRN), insulin infusion pumps (LZG) and automated external defibrillators (NSA and MKJ) are devices that should be considered “life sustaining.” We urge FDA to reevaluate its proposed list and take a more expansive interpretation of the devices that meet the commonsense definition of “implantable, life-saving, and life-sustaining.”

Thank you for your consideration of our comments. Should you have any questions, please contact Josh Rising at 202-540-6761 or jrising@pewtrusts.org.

Sincerely,

Josh Rising, MD

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