Voglio sapere a riguardo di…

jspears on DSK121TN23PROD with RULES1

66184

Federal Register / Vol. 86, No. 222 / Monday, November 22, 2021 / Rules and Regulations
Identification compliance date unless an exception or alternative applies. For those blood lancets that have been offered for sale prior to November 22, 2021, the comments: 1 Expressed concerns that the Unique Device Identification compliance date for class II and class III devices will have already passed when this order is published, and insufficient time will be provided to allow for compliance; 2 requested that a period of 2 or 3 years be provided for compliance with Unique Device Identification requirements; and 3
pointed out that industry anticipated that their class I devices would use the products Universal Product Code UPC
for purposes of unique device identifier UDI implementation as permitted under 801.40d 21 CFR 801.40d, and that FDA has not provided a reasonable basis to remove these devices from this provision. These comments further requested that FDA grant a general exception or alternative to allow the devices subject to this order, regardless of their classification, to utilize their UPCs as their UDIs.
Response 7 There are three principal elements to Unique Device Identification requirements: Labeling with a UDI, direct marking of devices that are intended to be used more than once and intended to be reprocessed between uses, and data submission to the Global Unique Device Identification Database GUDID see 801.20, 801.45, and 830.300 21 CFR 801.20, 801.45, and 830.300. In addition, the Unique Device Identification final rule 78 FR
58786, September 24, 2013 UDI Rule added 801.18 21 CFR 801.18, which requires certain dates on device labels to be in a standard format. As explained in the preamble to the UDI Rule, FDA
aligned the compliance date for standard date format requirements under 801.18 with the compliance date by which a device must bear a UDI
on its label and packages under 801.20
to avoid the need to make changes to a device label more than once to implement the requirements in the final rule.2 FDA disagrees 2 or 3 years is necessary for compliance with Unique Device Identification labeling and data submission requirements. Rather, FDA
considered the commenters request for additional time for compliance with UDI requirements and believes that the compliance timeframes set forth in section VI of this order provide sufficient time for manufacturers to perform all the functions required to comply with UDI labeling and data submission requirements, including converting manufacturing processes and 2 See
78 FR 58786 at 58795, September 24, 2013.

VerDate Sep<11>2014

17:19 Nov 19, 2021

Jkt 256001

associated inventory management, and submitting required information to GUDID. In addition, manufacturers should consult existing UDI compliance policies, which may be applicable to their reclassified devices. FDAs publicly available UDI web page 3
contains a comprehensive listing of UDI
guidance documents and compliance policies.
FDA also disagrees that manufacturers of blood lancets should be permitted to utilize their UPCs as their UDIs. As indicated in the preamble to the UDI
Rule 78 FR 58786 at 58798 the exception in 801.40d was purposely limited to class I devices due to their relative low risk. For the reasons stated in the preamble to this order, FDA no longer considers the blood lancet devices to be low risk and is reclassifying them into class II and class III. Therefore, the exception in 801.40d will no longer apply to these devices, and FDA does not believe that a general exception or alternative to the UDI labeling requirements would not be appropriate. An individual labeler that believes a UPC rather than a UDI on its device label would provide for more accurate, precise, or rapid device identification or would better ensure the safety or effectiveness of the device, may submit a request for an alternative under 21 CFR 801.55.
Comment 8 Several comments stated that the proposed special controls are unclear and unnecessary for blood lancets for single patient use blood lancets. Other comments specifically requested clarification of the following special controls: 1 Design characteristics related to single use only blood lancets without an integral sharp injury prevention, 2 possible recognized consensus standards for mechanical performance testing, 3
sterility testing for the lancet only, and 4 FDA identification of recognized consensus standards for biocompatibility testing and clarification on whether testing should be completed for the finished product or only the lancet.
Response 8 FDA continues to believe that special controls are necessary for single patient use only blood lancets. At the Panel meeting, FDA presented an analysis of the risks to health associated with the use of blood lancets and new scientific data supporting these risks. These risks to health are summarized in tables 1 to 3
of the 513e Proposed Order 81 FR
11140 at 11147. After deliberation, the Panel concluded that the risks to health warranted reclassification of blood 3 Available
PO 00000

at: https www.fda.gov/udi.

Frm 00030

Fmt 4700

Sfmt 4700

lancets from class I devices, as general controls were deemed insufficient to provide a reasonable assurance of safety and effectiveness. The proposed special controls are intended to inform manufacturers of the testing and information FDA believes to be necessary to provide a reasonable assurance of safety and effectiveness during the use of blood lancets, including single patient use only blood lancets.
FDA understands the confusion regarding the special control for single use only blood lancets without an integral sharps injury prevention feature regarding design to prevent sharp object injuries. The special controls for single patient use only blood lancets established by this final order are necessary to provide a reasonable assurance of safety and effectiveness for those devices. Each subset of blood lancets presents similar risks to health, but requires different special controls due to their different design characteristics and risk profiles. Design characteristics for blood lancets without an integral sharp injury prevention feature must still address the risks of sharp object injuries and bloodborne pathogen transmissions see 878.4850b2i. Examples of how this could be achieved include, but may not be limited to, the inclusion of a cap or blade cover. As described in the 513e Proposed Order 81 FR 11140
and adopted in this final order, these risks are also mitigated by mechanical performance testing to prevent device breakage and labeling. FDA believes that to satisfy the mechanical testing special control manufacturers must demonstrate injury prevention features as applicable and blade performance in single use single patient devices see 878.4850a2ii and b2ii;
however, there is currently no FDArecognized consensus standard for mechanical tests, methods, or acceptance criteria for this device type.
At the Panel meeting, FDA presented an analysis of the risks to health associated with the use of blood lancets and new scientific data supporting these risks. FDA believes that reusable components of single patient use devices, such as reusable bases, should be adequately cleaned and disinfected i.e., reprocessed between uses in order to prevent risk of infection. Sterility testing is applicable to any device component that breaches the skin, thereby contacting the underlying sterile tissue and/or blood in order to mitigate the risk of infection. While this requirement commonly applies to the blade of the blood lancet device, it may be possible for other components of a
E:FRFM22NOR1.SGM

22NOR1