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Federal Register / Vol. 86, No. 222 / Monday, November 22, 2021 / Rules and Regulations risks. Beyond mitigating the risk of infection, the Panel felt that reprocessing validation was necessary to demonstrate the functionality of the device over its lifetime, since the device could degrade when subjected to multiple cleaning and disinfection cycles Ref. 2. FDAs guidance entitled Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling provides recommendations for validation methods and labeling for proper cleaning of reusable medical devices that are consistent with the special controls in this final order Ref. 3.
Furthermore, the special controls for proper cleaning and disinfection of reusable components in this final order are also consistent with the recommendations in FDAs guidances Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use and Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use, which concern devices that are used by some of the same patient populations as those using blood lancets, both in a home use and clinical environment Refs. 1 and 4.
FDA continues to believe that use of EPA-registered disinfectants is necessary for cleaning and disinfection of the multiple use blood lancets for single patient use even for home use settings. FDA recommends utilizing disinfectants that are effective against bloodborne pathogens, such as Human Immunodeficiency Virus HIV, Hepatitis B, and Hepatitis C viruses.
FDA also recommends the use of EPAregistered disinfectants because they have been demonstrated to be effective against specific bloodborne pathogens when used for specified contact times.
EPA-registered disinfectants, which include both commercially registered disinfectants and commonly available generic disinfectant agents, are not allowed to make efficacy claims against specific pathogens unless the EPA has reviewed data to support those claims.
FDA notes that preparation of skin is part of standard patient care prior to drawing blood from patients, and that current guidelines and standards Refs.
5 and 6 generally include cleaning and disinfection of skin prior to capillary blood sampling. The purpose of this skin preparation step is to prevent infections caused by entry of microbial flora on the patients skin into the puncture wound created by the blood lancet. Nonetheless, FDA recognizes that the skin preparation procedure may differ depending on the particular application and/or clinical use, and that specific guidelines may exist for skin preparation for certain clinical
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applications. As such, FDA has revised the special control regarding instructions on cleaning and disinfection of the skin to be pierced to instead state instructions on preparation e.g., cleaning, disinfection of the skin to be pierced.
As a result of the available scientific information, FDA has determined that labeling special controls are necessary to address safety risks associated with use as labeled, and possible misuse, of blood lancets. In particular, it is critical to have specific required labeling special controls related to the preparation of skin and reprocessing of blood lancets for single patient use devices to provide a reasonable assurance of safety and effectiveness.
Comment 5 Several comments stated that the proposed labeling for single patient use only blood lancet devices is inadequate, overly prescriptive, and/or unnecessary for blood lancets used in home use environments.
Response 5 FDA continues to believe that the labeling proposed as special controls for single patient use only blood lancets subsets 1, 2, and 3
are necessary to provide a reasonable assurance of safety and effectiveness for these devices and believes the current labeling for blood lancets is inadequate.
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. In the data that was presented, it was shown that the risk of bloodborne pathogen transmission was related to the improper use of blood lancets. FDA
believes that additional labeling is needed to address this safety risk associated with misuse of blood lancets, including detailed descriptions of the proper use of the device and any sharps injury prevention feature, hand washing instructions for the user before and after use of the device, instructions on cleaning and disinfection of the device and to the skin to be pierced, and instructions for the safe disposal of the device Ref. 2. For each environment of use for blood lancets, adequate labeling must be included to address either use of these devices in healthcare settings or labeling for home use that is written for the end users to be able to understand and follow the instructions.
FDA has determined that general controls alone are not sufficient to provide a reasonable assurance of safety and effective for these devices subsets 1, 2, and 3, and there is sufficient information to establish special controls to provide such an assurance; therefore, FDA is reclassifying these devices into class II 81 FR 11140 at 11142. The Panel consensus was that single patient
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use only blood lancets meet the statutory definition of a class II device and require labeling special controls related to the cleaning and disinfection of skin and blood lancets for single patient use devices to reasonably assure safety and effectiveness.
Comment 6 Some comments stated that the proposed 180-day timeframe is too short for manufacturers of single patient use blood lancets subsets 1 to 3 to demonstrate conformance with the required special controls and submit a premarket notification 510k. The comments recommended timeframes ranging from 1 to 2 years for the submission of new 510ks for these types of blood lancets.
Response 6 FDA agrees with the commenters concern that its proposal to not enforce compliance with the 510k requirement or special controls for single patient use only blood lancets until 180 days after the effective date of the final order may not be enough time for all manufacturers of single patient use blood lancets to implement the required special controls and receive 510k clearance for those devices without prior 510k clearance. The typical review time for a 510k is 90
days. However, if a 510k submission lacks the information necessary for the Agency to continue or complete review, FDA may issue a request for additional information to the submitter and place the 510k on hold pending receipt of a complete response to the identified deficiencies. FDAs current policy is to allow a sponsor 180 days to respond to a request for additional information,1
resulting in a maximum review time of 270 days. Therefore, even if a submission were made on the effective date, there could be instances where a 510k submission would remain pending beyond 180 days after the effective date of the final order. FDA, therefore, does not intend to enforce compliance with the 510k requirement or special controls until 1 year after the effective date of this final order for blood lancets for single patient use only that have been offered for sale prior to the publication of this final order but do not already have a 510k clearance.
Comment 7 There were several comments relating to the Unique Device Identification labeling and data submission requirements. These requirements apply to all devices in commercial distribution as of their established Unique Device 1 See page 6 of Guidance for Industry and Food and Drug Administration Staff entitled FDA and Industry Actions on Premarket Notification 510k Submissions: Effect on FDA Review Clock and Goals, available at https www.fda.gov/media/
73507/download.

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