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Federal Register / Vol. 86, No. 222 / Monday, November 22, 2021 / Rules and Regulations 2 For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.
vi Labeling must also include the following statements, prominently placed:
A For use only on a single patient.
Discard the entire device after use.
B Warning: Not intended for more than one use. Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested.
b Single use only blood lancet without an integral sharps injury prevention feature1 Identification. A
disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, nonreusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.
2 Classification. Class II special controls. The special controls are:
i The design characteristics of the device must ensure that the structure and material composition are consistent with the intended use and address the risk of sharp object injuries and bloodborne pathogen transmissions.
ii Mechanical performance testing must demonstrate that the device will withstand forces encountered during use.
iii The device must be demonstrated to be biocompatible.
iv Sterility testing must demonstrate the sterility of any device component that breaches the skin e.g., blade.
v Labeling must include:
A Detailed descriptions, with illustrations, of the proper use of the device.
B Handwashing instructions for the user before and after use of the device.
C Instructions on preparation e.g., cleaning, disinfection of the skin to be pierced.
D Instructions for the safe disposal of the device.
E Labeling must be appropriate for the intended use environment.
1 For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.
2 For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.
vi Labeling must also include the following statements, prominently placed:
A For use only on a single patient.
Discard the entire device after use.
B Warning: Not intended for more than one use. Do not use on more than
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one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested.
c Multiple use blood lancet for single patient use only1 Identification. A
multiple use capable blood lancet intended for use on a single patient that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.
2 Classification. Class II special controls. The special controls are:
i The design characteristics of the device must ensure that:
A The lancet blade can be changed with every use, either manually or by triggering a blade storage unit to discard the used blade and reload an unused blade into the reusable base; and B The structure and material composition are consistent with the intended use and address the risk of sharp object injuries and bloodborne pathogen transmissions and allow for validated cleaning and disinfection.
ii Mechanical performance testing must demonstrate that the device will withstand forces encountered during use.
iii The device must be demonstrated to be biocompatible.
iv Sterility testing must demonstrate the sterility of any device component that breaches the skin e.g., blade.
v Validation testing must demonstrate that the cleaning and disinfection instructions are adequate to ensure that the reusable lancet base can be cleaned and low level disinfected.
vi Labeling must include:
A Detailed descriptions, with illustrations, of the proper use of the device.
B The Environmental Protection Agency EPA registered disinfectants contact time for disinfectant use.
C Handwashing instructions for the user before and after use of the device.
D Instructions on preparation e.g., cleaning, disinfection of the skin to be pierced.
E Instructions on the cleaning and disinfection of the device.
F Instructions for the safe disposal of the device.
G Instructions for use must address the safe storage of the reusable blood lancet base between uses to minimize contamination or damage and the safe storage and disposal of the refill lancet blades.
H Labeling must be appropriate for the intended use environment.
1 For those devices intended for health care settings, labeling must address the health care facility use of
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these devices, including how these lancets are to be used with personal protective equipment, such as gloves.
2 For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.
vii Labeling must also include the following statements, prominently placed:
A For use only on a single patient.
Disinfect reusable components according to manufacturers instructions between each use.
B Used lancet blades must be safely discarded after a single use.
C Warning: Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested. The cleaning and disinfection instructions for this device are intended only to reduce the risk of local use site infection; they cannot render this device safe for use for more than one patient.
d Multiple use blood lancet for multiple patient use1 Identification.
A multiple use capable blood lancet intended for use on multiple patients that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.
2 Classification. Class III premarket approval.
Dated: November 16, 2021.
Lauren K. Roth, Associate Commissioner for Policy.
FR Doc. 202125376 Filed 111921; 8:45 am BILLING CODE 416401P

DEPARTMENT OF HOMELAND
SECURITY
Coast Guard 33 CFR Part 165
Docket Number USCG20210077
RIN 1625AA11

Regulated Navigation Area; Biscayne Bay Causeway Island Slip, Miami Beach, FL
Coast Guard, DHS.
Final rule.

AGENCY:
ACTION:

The Coast Guard is establishing a Regulated Navigation Area over certain navigable waters of the Biscayne Bay Causeway Island Slip, immediately west of the Coast Guard Base Miami Beach, Miami Beach, FL.
This action is necessary to provide for the safety of life and federal property on
SUMMARY:

E:FRFM22NOR1.SGM

22NOR1