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Federal Register / Vol. 86, No. 193 / Friday, October 8, 2021 / Rules and Regulations
Medical Device Safety Communications to describe FDAs analysis of a current issue or problem and provide specific regulatory approaches and clinical recommendations for patient management. FDAs publicly available Medical Device Reporting Database includes information on devices that may have malfunctioned or caused a death or serious injury. Likewise, FDAs publicly available Medical Device Recalls database provides information on medical device recalls. In addition, FDA posts consumer information about Class I and some Class II and III recalls on its website in order to ensure that patients are aware of the seriousness of the potential health hazard posed by exposure to the product.
Comment 3 Some commenters discussed the benefits of surgical staplers for internal use, such as decreasing operative time, reducing surgical variability, and enabling more complex surgical procedures. Some commenters stated that the risks of the device need to be considered against these benefits, and that the number of adverse events need to be considered in the context of the large number of surgical procedures performed using these devices.
Response 3 FDA agrees that surgical staplers for internal use offer many important benefits, and that the risks of these devices need to be considered against their benefits. As described in the proposed order, FDA set forth the proposed reclassification and a substantive summary of the valid scientific evidence, including the public health benefits of the use of the device, and the nature and incidence of the risks of the device. Based on our analysis of the benefits and risks posed by surgical staplers for internal use, FDA determines that general controls on their own are insufficient to provide reasonable assurance of safety and effectiveness. The special controls identified in this final order, together with general controls, are necessary to provide a reasonable assurance of safety and effectiveness for surgical staplers for internal use, and as such, class II is the more appropriate classification for these devices.
Comment 4 Similar to the Panels feedback, some commenters felt that increased risk of cancer recurrence should be removed from the list of risks to health due to lack of evidence associating surgical staplers for internal use with an increased risk of cancer recurrence.
Response 4 As discussed above, in section II. B., while surgical stapler malfunctions have resulted in complications such as anastomotic
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leaks, and anastomotic leaks have been associated with an increased risk of cancer recurrence, FDA agrees that there is limited evidence directly linking surgical stapler failure/malfunction with an increased risk of cancer recurrence Refs. 24. Therefore, FDA agrees with removing increased risk of cancer recurrence from the list of complications associated with device failure/malfunction in the risks to health.
Comment 5 Similar to the Panels feedback, some commenters felt that adverse tissue reaction should be removed as a risk to health associated with surgical staplers for internal use, as the stapler only has incidental contact with the patient.
Response 5 As discussed above, in section II.B., FDA does not agree that adverse tissue reaction should be removed as a risk to health, as staplers for internal use contain patientcontacting materials that contact internal tissues, and these patientcontacting device materials may pose a risk of adverse tissue reaction if not adequately demonstrated to be biocompatible. The demonstration of biocompatibility for these devices is consistent with our approach for other devices with similar type and duration of contact, therefore the associated special control has also been maintained Ref. 5.
Comment 6 Some commenters requested that FDA work collaboratively with industry and professional societies to develop the special controls e.g., specific language for warnings and to develop a uniform color coding system for all stapler reloads.
Response 6 FDA has considered extensive comments from industry, professional societies, and other stakeholders in developing the special controls in this final order. While color coding is helpful and FDA would support development of a uniform color coding system if it came from a consensus body, FDA believes that the special controls in this final order, together with general controls, are sufficient to provide a reasonable assurance of safety and effectiveness for surgical staplers for internal use.
Comment 7 One commenter stated that the special controls for surgical staplers for internal use should be established in accordance with least burdensome principles.
Response 7 As stated in FDAs guidance, The Least Burdensome Provisions: Concepts and Principles, FDA defines least burdensome to be the minimum amount of information necessary to adequately address a relevant regulatory question or issue
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through the most efficient manner at the right time Ref. 6. FDA used the least burdensome approach in weighing the risks of surgical staplers for internal use with their benefits. FDA finds that the special controls identified in this final order represent the minimum amount of information necessary to provide a reasonable assurance of the safety and effectiveness of these devices.
Comment 8 One commenter felt that the proposed performance testing special controls represented a reasonable approach for evaluating the safety and effectiveness of surgical staplers for internal use, but that greater specifics regarding the standards, methods, and relevance of the proposed testing controls are needed to fully evaluate the proposed special controls.
Response 8 FDA agrees that the performance testing special controls identified in this final order are necessary to provide a reasonable assurance of the safety and effectiveness for these devices. FDA notes that the performance testing special controls are stated broadly to allow flexibility in different approaches in complying with the special controls.
Comment 9 Some commenters noted that firing force is an important parameter for manual surgical staplers for internal use, but is not applicable to powered surgical stapler devices.
Response 9 FDA agrees that firing force is an important parameter applicable to manual surgical staplers for internal use and is not applicable to powered surgical staplers. Therefore, FDA has revised the performance testing special controls to include measurement of the worst-case deployment pressures on stapler firing force specifically for manual staplers.
Comment 10 Similar to the Panels feedback, some commenters noted the importance of ensuring that the product labeling and instructions for use do not interfere with clinical decision making and a physicians ability to exercise his or her professional judgement. The commenters noted that too much information in the product labeling can make the labeling difficult to read, reducing its value to physicians, and provided a general recommendation to make the labeling special controls less prescriptive.
Response 10 As discussed above, in section II, regarding the Panels discussion of the proposed special control for a labeling comprehension study, FDA acknowledges the concern that too much information in the product labeling can make the labeling difficult to read, and that it is important for the labeling to be clear for the user.
However, FDA also notes that, as
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