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Federal Register / Vol. 86, No. 193 / Friday, October 8, 2021 / Rules and Regulations 2. Special Controls The Panel discussed and provided recommendations regarding the biocompatibility, labeling comprehension study, labeling, and sterility special controls identified in the proposed order. The Panel also discussed the possible addition of special controls regarding use of registries and powered staplers.
As discussed above in section II.B.1., FDA has not removed the special control regarding biocompatibility since surgical staplers for internal use contain patient-contacting device materials that may pose a risk of adverse tissue reaction if not adequately demonstrated to be biocompatible.
FDA acknowledges and agrees with the Panels recommendation that labeling comprehension testing should focus on evaluation of the clarity of the labeling rather than on the users comprehension of the labeling. In response to the Panels recommendation to revise the term labeling comprehension study in the special controls, FDA notes that the term labeling comprehension study is commonly used when referring to a study assessing the extent to which the labeling conveys the intended message to the user, such that the user can understand and apply this information when making decisions regarding device selection and use. However, a labeling comprehension study may not be the only way to assess how well the labeling results in use of the device as intended, therefore we are revising this special control to use the term human factors testing in place of usability testing and labeling comprehension study. FDA continues to find that such human factors testing is necessary to mitigate the risk of complications associated with use error or improper device selection and use specifically related to device labeling.
Based, in part, on feedback from the Panel that the labeling should allow surgeons to exercise their own clinical judgement, FDA has made several edits to the labeling special controls. FDA has revised the warning regarding establishing and maintaining proximal control of blood vessels to state establishing proximal control of blood vessels prior to stapling where practical and to also include methods of blood vessel control in the event of stapler failure. FDA has revised the warning regarding avoidance of use of the stapler on large blood vessels, such as the aorta to state avoidance of use of the stapler on the aorta. FDA has also removed the requirement to include specific user instructions for evaluation
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of the resultant staple line from the labeling special controls.
While the Panel had a distinct discussion on the possible addition of registries as a special control, use of registries was not added as a special control due in part to the divergence of the Panels opinion on the necessity for a registry as part of device reclassification. While FDA
acknowledges that use of registries may be helpful in understanding the performance of these devices, FDA
determines that mandating the use of registries is not needed to provide a reasonable assurance of the safety and effectiveness of surgical staplers for internal use.
Finally, the Panel did not disagree with FDAs request to consider the inclusion of specific special controls for powered surgical staplers for internal use. Special controls regarding electrical safety, electromagnetic compatibility, software verification, validation, and hazard analysis for powered staplers have been added accordingly. While FDA acknowledges that powered staplers may have unique sterility considerations as discussed by the Panel, FDA notes that all surgical staplers, both manual and powered, must be demonstrated to be sterile.
Therefore, the special control regarding sterility Performance data must demonstrate the sterility of the device remains unchanged.
III. Comments on the Proposed Order and FDA Response to Comments A. Introduction In response to the April 24, 2019, proposed order 84 FR 17116, FDA
received seven sets of comments to the docket for the proposed order FDA
2019N1250, some of which contain one or more comments on more than one issue. In addition, FDA received two sets of public comments to the docket for FDAs draft guidance, Surgical Staplers and Staples for Internal UseLabeling Recommendations FDA2019D
1262 that contained one or more comments regarding the proposed order.
Collectively, these comments originated from individual consumers, academia, healthcare professionals, healthcare associations, and industry. All commenters support the proposed reclassification of surgical staplers for internal use, and a few expressed concerns regarding specific special controls, which we address in section B.
below.
Additionally, FDA received some comments to the docket for the proposed order that are regarding FDAs
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Draft Surgical Staplers and Staples for Internal UseLabeling Recommendations guidance.
Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability for the final Surgical Staplers and Staples for Internal Use Labeling Recommendations guidance.
These comments were considered in the finalization of this guidance. As discussed below, FDA intends for the Surgical Staplers and Staples for Internal UseLabeling Recommendations guidance to provide recommendations to help manufacturers comply with the labeling special controls. As such, FDA has utilized the Surgical Staplers and Staples for Internal UseLabeling Recommendations guidance to provide additional clarification, where appropriate.
The order of response to the commenters is purely for organizational purposes and does not signify the comments value or importance nor the order in which comments were received. Certain comments are grouped together under a single number because the subject matter is similar.
B. Description of Comments and FDA
Response Comment 1 Some commenters shared their own personal experiences with surgical staplers for internal use, such as adverse events experienced during surgeries, types of malfunctions encountered with surgical staplers, or best practices taken to help ensure safety of surgical staplers. One of these commenters encouraged FDA to put into effect whatever additional safety measures it sees fit to make surgical staplers for internal use safer.
Response 1 FDA notes that, as discussed in the proposed order, malfunctions and misuse associated with surgical staplers for internal use have resulted in serious adverse events, including deaths. FDA determines that reclassifying surgical staplers for internal use from class I to class II, establishing special controls, and requiring premarket review will help ensure a reasonable assurance of safety and effectiveness for these devices.
Comment 2 One commenter requested that FDA consider establishing requirements to make public announcements about large scale problems with medical devices.
Response 2 Requiring public announcements about large scale problems with medical devices falls outside the scope of FDAs reclassification of surgical staplers for internal use described in this final order. Nonetheless, FDA routinely posts
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