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September 29, 2014

Food, Drug & Device Law Alert - FDA Amends Proposed Rule on Unique Medical Device Identification

The U.S. Food and Drug Administration (FDA) recently announced an amendment to its proposed rule to require most medical devices distributed in the United States to carry a unique device identifier (UDI). According to FDA, the amendment is required by the FDA Safety and Innovation Act (FDA SIA) signed into law in early July of this year.

Under the proposed rule, a UDI is a unique numeric or alphanumeric code that includes a device identifier and a production identifier. The device identifier is specific to a labeler (typically, the manufacturer) and device model. The production identifier includes the current production information for that specific device, such as the lot or batch number, the serial number and/or expiration date.

The proposed rule requires the label of medical devices and device packages to include a UDI, with certain exceptions for alternative placement of the UDI and for particular devices or device types. Each UDI would have to be provided in a plain-text version and in a form that uses bar code, RFID, or similar technology. The UDI would also be required to be directly marked on the device itself for certain categories of devices, such as implantable devices.

The proposed rule originally provided that any final rule would become effective in stages over a period of seven years. One year after publication of the final rule, the label and package for class III medical devices were to bear a UDI. Class II device labels followed two years later, and class I and unclassified labels followed two more years after class II. For devices that must be marked, the start date for class III devices is three years after publication of the final rule, with class II following two years later and class I and unclassified following two more years later.

The recent amendment to the proposed rule bears on the effective date for certain types of devices. As amended by FDA SIA, Section 519(f) of the Food, Drug & Cosmetic Act now requires that FDA “shall implement the final regulations with respect to devices that are implantable, life-saving, and life sustaining not later than 2 years after the regulations are finalized, taking into account patient access to medical devices and therapies.” Accordingly, FDA amended the proposed rule to bring the effective dates into compliance with FDA SIA. The amendment includes the following chart showing the effect of the amendment:

Category of Device

Effect of Amendments on Proposed Rule

Class III implantable, life-supporting, and life-sustaining devices, and implantable, life-supporting, and life-sustaining devices licensed under the PHS Act.

No effect with respect to proposed requirement for device to bear UDI on the label and device package or proposed requirements for submission of data to the GUDID.

Implantable devices would have to bear a UDI as a permanent marking on the device itself 1 year earlier than first proposed.

Class II implantable, life-supporting, and life-sustaining devices

Would have to bear a UDI on the label and device package and submit data to the GUDID 1 year earlier than first proposed.

Implantable devices would have to bear a UDI as a permanent marking on the device itself 3 years earlier than first proposed.

Class I implantable, life-supporting, and life-sustaining devices, and implantable, life-supporting, and life-sustaining devices that have not been classified into class I, II, or III

Would have to bear a UDI on the label and device package and submit data to the GUDID 3 years earlier than first proposed.

Implantable devices would have to bear a UDI as a permanent marking on the device itself 5 years earlier than first proposed.

The amendment also includes the following helpful, albeit somewhat complicated, chart summarizing the effective dates of the proposed rule after the amendment:

Effective Date

Requirement

Immediately upon publication of a final rule.

 

Requests for an exception or alternative to UDI labeling requirements may be submitted pursuant to § 801.35.

§§ 830.100 - 830.130 (subpart C of part 830, concerning accreditation of issuing Agencies) and § 830.10 (incorporation by reference of certain standards) go into effect.  This will allow applications for accreditation as an issuing Agency to be submitted to FDA immediately.

One year after publication of a final rule

Dates on medical device labels must be formatted as required by § 801.18.

The label and package of class III medical devices and devices licensed under the PHS Act must bear a UDI. § 801.20(b)(1).

Data for class III devices and devices licensed under the PHS Act that are required to be labeled with a UDI must be submitted to the GUDID data base. § 830.300.

Two years after publication of a final rule

The label and package of implantable, life-supporting, and life-sustaining devices that are not class III devices or licensed under the PHS Act must bear a UDI. § 801.20(b)(2).

Data for implantable, life-supporting, and life-sustaining devices that are not class III devices or licensed under the PHS Act and that are required to be labeled with a UDI, must be submitted to the GUDID data base. § 830.300.

All implantable devices required to be labeled with a UDI must bear a UDI as a permanent marking on the device itself. § 801.50.

Three years after publication of a final rule

Class III devices required to be labeled with a UDI must bear a UDI as a permanent marking on the device itself if the device is 1) a device intended to be used more than once and intended to be sterilized before each use, or 2) stand-alone software regulated as a medical device. § 801.50.

The label and package of class II medical devices must bear a UDI. § 801.20(b)(3).

Data for class II devices that are required to be labeled with a UDI, must be submitted to the GUDID data base. § 830.300.

Five years after publication of a final rule

 

Class II devices required to be labeled with a UDI must bear a UDI as a permanent marking on the device itself if the device is 1) a device intended to be used more than once and intended to be sterilized before each use, or 2) stand-alone software regulated as a medical device. § 801.50.

The label and package of class I medical devices and devices that have not been classified into class I, class II, or class III must bear a UDI. § 801.20(b)(4), (5).

Data for class I devices and devices that have not been classified into class I, class II, or class III that are required to be labeled with a UDI must be submitted to the GUDID data base. § 830.300.

Seven years after publication of a final rule

Class I devices and devices that have not been classified into class I, class II, or class III required to be labeled with a UDI must a bear UDI as a permanent marking on the device itself if the device is 1) a device intended to be used more than once and intended to be sterilized before each use, or 2) stand-alone software regulated as a medical device. §801.50.

90 days after  publication of a final rule

All other provisions go into effect, although some will have no practical effect until other provisions listed in this table go into effect.

The FDA announced the amendment after the close of the period for public comment on the proposed rule, and stated that it does not believe the amendment requires it to re-open the comment period.

The full text of the amendment can be found by clicking here.

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Lynn C. Tyler, M.S, Barnes Thornburg Law Firm, Patent Attorney
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Lynn C. Tyler is a partner and registered patent lawyer in the firm’s Intellectual Property Department. Mr. Tyler helps innovative companies secure and preserve their market position and competitive advantage by navigating their way through the FDA to the marketplace and enforcing their intellectual property rights, which often must be protected against imitators who seek to reap where they have not sown. He litigates intellectual property matters and represents clients at virtually all stages of the process, including pre-litigation counseling, alternative dispute resolution, formal...

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Hae Park-Suk is of counsel in the Washington, D.C., office and a member of the Intellectual Property Department. Ms. Park-Suk counsels clients on the selection, adoption, availability, and proper use of trademarks. Her practice consists of searching and clearing trademarks, prosecuting domestic and international trademark applications, managing extensive foreign trademark portfolios, assisting clients in planning and structuring their worldwide trademark strategies, assisting clients in protecting and enforcing their trademarks in the U.S. and worldwide, coordinating intellectual property...

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Barnes & Thornburg's Food, Drug & Device Law practice group helps pharmaceutical, biotechnology, medical device, diagnostic, food, dietary supplement and cosmetic companies, as well as other healthcare entities, throughout the product lifecycle, from concept, development and approval to manufacturing, marketing, ongoing compliance, investigation, enforcement actions and litigation. We advise clients on the ever-evolving laws and FDA regulations that govern their products and components. Moreover, we have the government experience and industry knowledge necessary to...

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