{Insert Company Letterhead}
November 7, 2012
Margaret A. Hamburg, M.D., Commissioner
Food and Drug Administration
Division of Dockets Management (HFA–305)
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
Docket No. FDA–2011–N–0090; RIN No. 0910–AG31
Re: Unique Device Identification System; Proposed Rule
Dear Commissioner Hamburg:
On behalf of ______________, I write in response to the Food and Drug Administration (FDA) Unique Device
Identifier (UDI) Proposed Rule. __________ urges the FDA to make the following changes to its final rule to
ensure the UDI system is implemented in an efficient and cost-effective manner:
1.
2.
3.
4.
5.
Exempt class I medical devices from UDI requirements;
Clarify the proposed retail exemption to include all over-the-counter (OTC) devices;
Exempt class I medical devices that are in convenience kits;
Extend implementation for all kits to 2018; and
Secure database reporting by offering alternatives to third-party reporting vendors.
(Describe your company)
Class I medical devices do not require UDI
A clear class I exemption is necessary to implement a clean and effective UDI tracking system at this time. As
currently proposed, the rule creates a confusing and inconsistent application of UDI for this class of devices. Class I
devices do not require a UDI because, as the FDA recognizes, they are primarily low-to-no risk products that are
used in everyday medical care. These products are delivered and received in high-volume shipments that rely on an
efficient supply chain.
Specifically, the proposed rule creates new subgroups of class I devices that will significantly disrupt the supply
chain. The UDI proposed rule includes two partial exemptions for class I devices: 1) devices already exempt from
good manufacturing practices (GMP)1 and 2) a potential exemption from a production identifier label. These will
create separate tracking standards between supply chain partners and complicate labeling protocols among
manufacturers and distributors.
1
Proposed § 801.30(a)(2), UDI Proposed Rule, FDA, July 16, 2012.
Comments Re: Docket No. FDA–2011–N–0090; RIN No. 0910–AG31
November 7, 2012
Page 2
The FDA states in the proposed rule that class I devices are low risk.2 Current FDA regulations recognize a
distinction between class I and class II or III devices, as the FDA has “exempted almost all class I devices from the
510(k) process”3, which is designed to ensure devices are safe and effective before they go to market.
Class II and III devices deemed to be high-risk, such as implantables, are subject to an even more rigorous
premarket approval (PMA) process. The FDA further acknowledges under its General Controls for Medical
Devices that class I devices present “minimal potential for harm to the user” and are “simpler in design than class II
or class III devices.”4
_____________ agrees with the FDA that GMP-exempt devices should not require a UDI. However, there are
many other essential medical supplies, such as latex patient examination gloves, that would not qualify for this
exemption. A clear class I exemption would ensure the FDA UDI system would not be burdened by tracking such
low risk devices.
Adding complexity and cost to the medical products supply chain would challenge the time-efficient and costeffective delivery of these commodity supplies. A clear class I exemption is necessary to implement an effective
UDI system.
Clarify the retail exemption to include all over-the-counter (OTC) devices
_____________ supports the retail exemption for medical devices, and asks that the FDA clarify this exemption to
include all over-the-counter (OTC) devices. As the FDA recognizes, this exemption will help reduce the overall
burden of the proposed rule on devices that are sold at retail establishments and sold “to a hospital or other health
care facility.”5
The FDA should clarify the differences between prescription and OTC devices. For example, 510(k) status can
demonstrate whether a device is considered OTC, however some distributors have experienced that 510(k)-exempt
products have not been classified as either prescription or OTC devices.
Exempt class I devices from UDI labeling within convenience kits
The proposed exemption for single-use devices within a convenience kit should be extended to all class I devices.
Many class I devices that go into kits (such as bandages) are packaged in bulk and then distributed to a batch of
kits. FDA regulations do not require many individual items within a kit to have a distinct label.6 Supply chain
stakeholders would be challenged to trace millions of different class I devices throughout each unit of packaging, as
these products are often scanned within large volume delivery and inventory systems.
2
Proposed Rule Summary, UDI Proposed Rule, FDA, July 16, 2012.
“Medical Device Exemptions 510(k) and GMP Requirements,” FDA, last updated October 19, 2012.
4
“General and Special Controls, Medical Devices” FDA, last updated April 23, 2009.
5
Proposed § 801.30(a)(1), UDI Proposed Rule, FDA, July 16, 2012.
3
6
“Convenience Kits Interim Regulatory Guidance,” FDA, December 17, 2010.
Comments Re: Docket No. FDA–2011–N–0090; RIN No. 0910–AG31
November 7, 2012
Page 3
Extend implementation date for all kits to 2018
____________ recommends delaying the implementation date for kits to five years after the final rule is released.
____________ further recommends that the FDA hold a public workshop in order to provide ample opportunity for
stakeholders and public health officials to discuss the uniqueness of convenience kits and the impact of the
proposed rule.
Convenience kits include an array of products within a single package to facilitate a medical or surgical procedure.
Hospitals and other providers rely on convenience kits as they improve a healthcare provider’s productivity, cost
management, and patient outcomes. Outstanding questions that need further discussion and clarity include:
1) Will the FDA define a medical convenience kit that contains a prescription or OTC drug as a combination
product? The inclusion of a drug should not change the definition of a medical convenience kit, but this
point is unclear.
2) Will a change to the specific contents of a kit, such as a product substitution for gauze or bandages,
necessitate a new UDI label?
3) How would a kit assembler ensure that a unit-level medical device placed within a kit has a UDI label if it is
derived from a lot-level package that has its own UDI label? Many simple, low risk devices may not be
considered “single use,” and it would be a significant challenge for a distributor to create new labels for
unit-level medical products.
4) How does the UDI rule treat class II devices which may be considered “single use” products?
5) How does the FDA envision a UDI label on the outside of a convenience kit that can include information
for multiple devices within a convenience kit? This level of information would mandate numerous barcodes
on a kit label and may create confusion.
6) Will a convenience kit that contains exclusively exempt medical devices be exempt from the UDI system
requirements?
Secure database reporting
To improve the Global Unique Device Identification Database (GUDID), _________ urges the FDA to secure
database reporting by offering software to assist in the Electronic Submissions Gateway (ESG). This will allow
distributors to upload information directly and protect proprietary information.
Distributors are active participants in multiple test programs and pilots for the (GUDID), which offers a unique
opportunity for labelers and public health officials to track medical devices throughout the supply chain.
_________ believes that these partnerships with the FDA have played an important role in harmonizing supply
chain standards and advancing an effective UDI data exchange.
Currently, ____________ is concerned that ESG reporting can only be accomplished through a third-party vendor.
This can be a time-consuming and costly effort for many distributors that otherwise have the ability to adopt
software and directly upload information. ESG reporting must be facilitated for the thousands of companies that
Comments Re: Docket No. FDA–2011–N–0090; RIN No. 0910–AG31
November 7, 2012
Page 4
will be mandated to make regular submissions under regulated timelines. Additionally, many companies would
prefer an “in-house” solution that can offer further safeguards to protect proprietary information. We urge the FDA
to issue further guidance on GUDID reporting and how the agency plans to protect data submissions and
proprietary company information.
Thank you for the opportunity to comment and we look forward to continuing to work with the agency to ensure
that the UDI system is implemented safely and effectively.
Sincerely,