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Federal Register / Vol. 86, No. 222 / Monday, November 22, 2021 / Rules and Regulations blood lancet besides a blade to breach the skin. Therefore, FDA has determined that the sterility special control should be revised to clearly state that this special control applies to any device component that breaches the skin e.g., the blade for the three single patient use subtypes of blood lancets.
The special control for biocompatibility testing must be conducted on the final finished form for the finished blood lancet device and is important to address the risk of adverse tissue reaction not infection.
Manufacturers are encouraged to review the relevant FDA guidance documents including, but not limited to the Submission and Review of Sterility Information in Premarket Notification 510k Submissions for Devices Labeled as Sterile Ref. 7 and Use of International Standard ISO 109931, Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing Within a Risk Management Process Ref. 8 for recommendations on how to comply with the special control testing requirements.
Evidence of compliance with the special controls is required to demonstrate reasonable assurance of safety and effectiveness and to support 510k clearance. As stated above, FDA
does not intend to enforce compliance with the premarket notification 510k requirement and special controls 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.
However, 1 year after the effective date of this order, any: 1 Single use only blood lancet with an integral sharps injury prevention feature that does not comply with the special controls established in 878.4850a2, 2
single use only blood lancet without an integral sharps injury prevention feature that does not comply with the special controls established in 878.4850b2, or 3 multiple use blood lancet for single patient use only established in 878.4850c2, will be considered adulterated and misbranded sections 501f1B and 502o of the FD&C Act 21 U.S.C. 351f1B and 352o until such time as the device complies with the special controls and any premarket notification requirements.
Comment 9 A comment stated that currently marketed blood lancets should be exempt from design controls because the safety concerns raised by those single patient use devices are related to the labeling and the use of blood lancets generally and not with the design of the device. Instead the comment suggests a phased-in approach for design control compliance for currently marketed
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devices, depending on whether they meet the requirements pursuant to 807.81a3 21 CFR 807.81a3.
Response 9 FDA disagrees with this comment. The lancet blade is designed to pierce the skin and draw blood and can present a puncture hazard to anyone coming into contact with the device when the blade is accessible. This hazard is associated with serious risks as described in the 513e Proposed Order 81 FR 11140. Without the application of design controls 21 CFR
820.30, FDA is unable to verify that appropriate controls are in place to ensure that blood lancet devices are designed and tested in such a way as to perform as intended under the labeled conditions of use, and to provide a reasonable assurance of safety and effectiveness. Therefore, FDA does not intend to allow a phased-in approach for design control compliance of currently marketed single patient use blood lancets.
Comment 10 A comment stated that the single patient use only blood lancet devices should be exempt from premarket notification under section 510m of the FD&C Act 21 U.S.C.
360m and suggested that special controls could be documented in the Design History File DHF for FDAs review during routine audits/
inspections.
Response 10 FDA does not agree that it is appropriate to exempt single patient use only blood lancets from premarket notification at this time. Section 510m of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510k of the FD&C Act if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. There are a number of factors FDA may consider to determine whether a 510k is necessary to provide reasonable assurance of the safety and effectiveness of a class II
device. These factors are discussed in the guidance that the Agency issued on February 19, 1998, entitled Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff Class II
510k Exemption Guidance Ref. 9.
Based on the scientific information available to the Agency at this time and summarized in the 513e Proposed Order, FDA has determined these factors currently are not met for single patient use only blood lancet devices and that premarket notification is necessary to provide reasonable assurance of safety and effectiveness for all three types of single patient use blood lancets.

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FDA also does not agree with the comment that the Agency should only review the DHF for a single patient use only blood lancet device to determine whether there exists a reasonable assurance of safety and effectiveness for the device. Under 21 CFR 820.3 a DHF
is a compilation of records that describes the design history of a finished device based on the quality system regulations. Although a manufacturer of a legally marketed device is required to keep a DHF for the devices design control requirements, FDA usually does not review the DHF
until postmarket surveillance inspections of a class II device. For single patient use only blood lancet devices, based on the scientific evidence available to the Agency, FDA believes in order for the Agency to determine whether there exists a reasonable assurance of safety and effective for a device, it is necessary for compliance with the special controls to be assessed prior to the device entering the market.
Comment 11 A comment recommended that FDA create a separate regulatory classification category for flat, stainless steel blood lancets in class I.
Response 11 FDA disagrees that a separate regulatory classification is needed for flat, stainless steel blood lancets in class I. FDA believes that the four subsets of lancets identified in this final order encompass flat, stainless steel blood lancets; that is, a flat, stainless steel blood lancet can be appropriately categorized in any of these four subsets based on its intended use e.g., single vs. multiple use and design characteristics e.g., presence or lack of a sharps injury prevention feature. Furthermore, at this time, FDA
finds that the same risks to health e.g., bloodborne pathogen transmission, local tissue infections, adverse tissue reactions described herein for blood lancets apply to flat, stainless steel blood lancets. Therefore, FDA finds that a separate categorization for flat stainless steel blood lancets in class I is neither necessary nor appropriate at this time.
Comment 12 One comment suggested FDA allow a bundling of several devices with the same intended use for a 510k submission.
Response 12 Bundling refers to the inclusion of multiple devices or multiple indications for use for a device in a single premarket submission, including products subject to the device and biologics license application BLA
authorities, for purposes of review and user fee payment. Multiple devices may include different models within a generic type of device 21 CFR 860.3 or
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