FDA Unique Device Identifier Final Regulations
November 13th, 2014 — On September 20, FDA issued a Final Rule for a new Unique Device Identifier System (UDI), which FDA believes will provide a consistent way to identify, and potentially recall medical devices after they are in commercial distribution. FDA received a specific statutory charge from Congress to implement this system, which has been in the works for several years and evolves from a proposed rule published in July, 2012.
In fact, AOPA members will recall the misguided proposal by PDAC which was published September 22, 2011 to require permanent identification labels on O&P devices effective February 1, 2012 and a further requirement that samples of such devices be submitted to PDAC. AOPA aggressively challenged the proposal enlisting the expertise of the Foley Hoag law firm and former FDA General Counsel, Richard Cooper, to present the case that only FDA has authority to implement labeling requirements on medical devices and submitting to PDAC non-reimbursable samples of custom O&P devices would be cost prohibitive. PDAC was further informed that their proposed requirement would duplicate expected Unique Device Identifier regulations from FDA as authorized by Congress. PDAC subsequently withdrew the proposal.
FDA has prioritized both the applicability of the UDI regs, as well as the compliance dates based on the levels of risk associated with devices. Higher risk devices have less time before they need to be in compliance. The regulations include several exceptions from the UDI rule. There are two that are significant as to many O&P devices—one favorable, and the second not so much.
(1) FDA is granting an exception (section 801.30(a)(2) from the specific rules applicable to the UDI as to medical devices classified in Class I, and as to which FDA has also granted exemptions from good manufacturing practices/QSR regulations. Many O&P devices will have the benefit of this exception—you will find attached a specific listing of devices within the FDA Physical Medicine Devices grouping under 21 CFR Section 890 that FDA has exempted from good manufacturing practices/QSR regulations, and which therefore are also granted the exception from the UDI.
(2) FDA also has established an exception as to devices which qualify as “custom devices” within the meaning of 21 CFR Section 812.3(b). The comments received on the proposed rule included a specific reference to cranial remolding orthoses claiming applicability under this provision, and the agency’s response was quite discouraging when they stated: “These are types of devices and do not categorically qualify as custom devices within the meaning of section 812.3(b).”
(3) Because there are some O&P devices which are assigned to FDA’s Class I, but which have not received an FDA exemption from good manufacturing practices/QSR regulations, device manufacturers will also be very interested in section 801.40(d) which has been amended to provide: “that a Class I device that bears a UPC (universal product code) on its label and device packages and is deemed to meet all UDI labeling requirements and that the UPC will serve as the UDI required by section 801.20. This grants exceptions for a class I device with a UPC on its label and packages from UDI labeling requirements regardless of to whom or through what channels it is sold….The labeler of such a device is still required to submit data concerning the device to the Global Unique Device Identification Database (GUDID), unless the UPC device also qualifies for the exemption under section 801.30(a)(2) as a Class I GMP exempt device.”
In theory, it is possible that there are O&P devices which: (a) are not exempted from good manufacturing practices/QSR regulations, AND (b) where labeling does not bear a UPC, and which therefore would be subject to UDI, which would also apply to devices falling into FDA Class II or Class III. Here are the relevant dates when compliance is required:
1. For a Class II medical device that is not an implantable, life-supporting or life-sustaining device – September 24, 2016
2. For a Class I medical device that is not an implantable, life-supporting or life-sustaining device – September 24, 2018
3. There is another subcategory of rules, applicable when the UDI is required to be displayed via ‘direct marking’ on the device itself (we do not expect there will be very many (if any) O&P devices that will require ‘direct marking’). The rule offers slightly more time, again providing it is not an implantable, life-supporting or life-sustaining device, the compliance date for these are two (2) years after the compliance date that would have applied if there had not been ‘direct marking’ required, namely:
a. Class II device — September 24, 2018
b. Class I device – September 24, 2020
4. There is also a provision which allows that devices that were manufactured before the effective date (September 24, 2013) which typically be permitted 3 years for sale into commerce without any penalty, even though they do not bear any UDI.
Where the UDI does apply, without exception, the UDI system consists of two core items. The first is a unique number assigned by the device manufacturer to the version or model of a device, called a unique device identifier. This identifier will also include production-specific information such as the product’s lot or batch number, expiration date, and manufacturing date when that information appears on the label.
The second component is a publicly searchable database administered by the FDA, called the Global Unique Device Identification Database (GUDID) that will serve as a reference catalogue for every device with an identifier. No identifying patient information will be stored in this device information center. FDA has established a procedure by which it will recognize and accredit private entities to assist companies with these database/software related tasks.
The following excerpts from the definitions outlining the specifics of the UDI will be of interest:
Unique device identifier (UDI) means an identifier that adequately identifies a device through its distribution and use by meeting the requirements of § 830.20 of this chapter. A unique device identifier is composed of:
(1) A device identifier–a mandatory, fixed portion of a UDI that identifies the specific version or model of a device and the labeler of that device; and
(2) A production identifier–a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of the device:
(i) The lot or batch within which a device was manufactured;
(ii) The serial number of a specific device;
(iii) The expiration date of a specific device;
(iv) The date a specific device was manufactured;
(v) For Human Cell & Tissue Products (HCT/P) regulated as a device, the distinct identification code required by §1271.290(c) of this chapter (obviously not applicable to O&P devices). Universal Product Code (UPC) means the product identifier used to identify an item sold at retail in the United States.
The regulations span approximately 160 pages, and obviously cover much more than is included in this summary. Devices being sold solely for export from the U.S. are not required to display a UDI. FDA has determined to require submission of MRI compatibility information to the GUDID, stating that “because identification of devices that are MRI compatible and ones that are not can be critical to the safety of patients, we have included a requirement for MRI compatibility information at section 830.310(b)(8).” Potential enforcement action for violations of UDI requirements include seizure, injunction, and civil and criminal penalties.
It is noted by FDA that 96 percent of domestic labelers are small firms according to Small Business Administration size standards. The average annualized costs of compliance for domestic labelers as a percentage of annual receipts for small firms that are NOT required to perform ‘direct marking’ does not exceed 1 percent of average annual receipts.
§ 801.55 Request for an exception from or alternative to a unique device identifier requirement.
(a) A labeler may submit a request for an exception from or alternative to the requirement of § 801.20 or any other requirement of this subpart for a specified device or a specified type of device. A written request for an exception or alternative must:
(1) Identify the device or devices that would be subject to the exception or alternative;
(2) Identify the provisions of this subpart that are the subject of the request for an exception or alternative;
(3) If requesting an exception, explain why you believe the requirements of this subpart are not technologically feasible
(4) If requesting an alternative, describe the alternative and explain why it would provide for more accurate, precise, or rapid device identification than the requirements of this subpart or how the alternative would better ensure the safety or effectiveness of the device that would be subject to the alternative;
(5) Provide, if known, the number of labelers and the number of devices that would be affected if we grant the requested exception or alternative; and
(6) Provide other requested information that the Center Director needs to clarify the scope and effects of the requested exception or alternative.
(b) A written request for an exception or alternative must be submitted by sending it by email to: email@example.com, or by correspondence to: UDI Regulatory Policy Support, Center for Devices and Radiological Health, Food and Drug Administration, Bldg. 66, rm. 3303, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002.
Specific Details of What Must Be Provided to FDA as to Devices Subject to UDI:
FDA agreed with one comment which stated that there should not be any consequences to the labeler of a device if the accreditation of the issuing agency is relinquished or revoked, and that the availability of GUDID data to patients and providers needs to be ensured.
Every unique device identifier (UDI) must meet the technical requirements of § 830.20 of this chapter. The UDI must be presented in two forms:
(1) Easily readable plain-text, and
(2) Automatic identification and data capture (AIDC) technology. The UDI must include a device identifier segment.
Section 830.320(a) requires that the submission of unique device identification information must include designation of contact for device identification. Each labeler must designate an individual to serve as the point of contact with FDA on matters relating to the identification of medical devices marketed by the labeler.
§ 830.310 designates information required for unique device identification. The contact for device identification designated under § 830.320(a) shall provide FDA with the following information concerning each version or model of a device required to bear a unique device identifier (UDI) on its label concerning the labeler:
(1) The name of the labeler;
(2) A telephone number or email address that will allow FDA to communicate with the contact for device identification designated under § 830.320(a); and
(3) The name of each issuing agency whose system is used by the labeler to assign UDIs used by the labeler.
Finally, each labeler shall retain, and submit to FDA upon specific request, records showing all unique device identifiers (UDIs) used to identify devices that must bear a UDI on their label, and the particular version or model associated with each device identifier. These records must be retained for 3 years from the date the labeler ceases to market the version or model.
Clearly the UDI rules represent an important new challenge for medical devices companies. AOPA will continue to provide updates on important information on this topic.