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Federal Register / Vol. 86, No. 193 / Friday, October 8, 2021 / Rules and Regulations
excludes trade secret and/or confidential commercial information, e.g., the contents of a pending premarket approval application see section 520c of the FD&C Act.
Section 510m of the FD&C Act provides that a class II device may be exempted from the premarket notification requirements under section 510k of the FD&C Act if the Agency determines that premarket notification is not necessary to assure the safety and effectiveness of the device. FDA has determined that premarket notification is necessary to reasonably assure the safety and effectiveness of surgical staplers for internal use. Therefore, the Agency has not exempted this class II
device from premarket notification 510k submission as provided under section 510m of the FD&C Act.
On April 24, 2019 84 FR 17116, FDA
published a proposed order in the Federal Register to reclassify surgical staplers for internal use the proposed order. FDA also proposed special controls and proposed amending the existing classification for manual surgical instrument for general use to remove staplers and to create a separate classification regulation for surgical staplers that distinguishes between surgical staplers for internal use and external use. The period for public comment on the proposed order closed on June 24, 2019. FDA received and has considered comments on the proposed order, as discussed in section III. FDA
also held a meeting of the General and Plastic Surgery Devices Advisory Panel the Panel on May 3031, 2019, in accordance with section 513b of the FD&C Act 21 U.S.C. 360cb Ref. 1. In publishing the proposed order, holding the Panel meeting, and considering comments to the docket, FDA has met the requirements for reclassification under section 513e1Ai of the FD&C Act.

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II. Panel Meeting A. Panel Feedback On May 30, 2019, the Panel met to discuss and make recommendations regarding the reclassification of surgical staplers for internal use from class I
general controls to class II special controls Ref. 1. At the Panel meeting, FDA presented the risks, mitigations, and special controls identified in the proposed order.
The Panel generally agreed that the list of risks and proposed mitigations proposed by FDA was accurate and agreed with FDA that the risk profile was consistent with class II devices.
Some Panel members noted that adverse tissue reaction may not be a particular
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risk due to the minimal patient contact duration with body tissues. Some Panel members also stated that increased risk of cancer recurrence should be removed from the list of risks, and no Panel members disagreed with that position.
The Panel generally agreed that FDAs proposed special controls are reasonable and sufficient to support reclassification of surgical staplers for internal use to class II. Some members noted that biocompatibility testing may not be needed as a special control due to the limited contact duration with tissues.
The Panel also believed that usability testing should be required, but recommended revision of the term labeling comprehension study in the special controls, since the Panel felt that the study should focus on evaluation of the labeling rather than on the user.
Some Panel members felt that certain warnings in the labeling special controls, such as establishing and maintaining proximal control of blood vessels prior to stapling and avoidance of use of the stapler on large blood vessels, should be removed, as they believed the labeling should allow the surgeon to exercise their own clinical judgement rather than dictating surgical practice. One Panel member additionally implied that the term large blood vessels is vague.
Some Panel members believed that a registry could be helpful as part of the special controls, but there was a divergence of opinion on the need for a registry as part of device reclassification and the ultimate utility of the data that would likely be collected.
The Panel also discussed unique sterility considerations regarding powered staplers. The Panel also discussed additional special controls that they believed were necessary for powered surgical staplers such as electrical safety and electromagnetic compatibility testing and software verification and validation. The Panel expressed the view that powered staplers should meet these requirements.
Based upon the available scientific evidence and risks to health posed by surgical staplers for internal use, the Panel unanimously recommended the reclassification of surgical staplers for internal use from class I general controls to class II special controls, agreeing with FDAs conclusion that general controls by themselves were insufficient to provide reasonable assurance of safety and effectiveness.

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B. FDA Response to Panel Feedback and Changes in the Final Order The Panel agreed with FDA in recommending the reclassification of surgical staplers for internal use from class I general controls to class II
special controls. The Panel generally agreed with the risks to health identified by FDA and the applicable special controls associated with the identified risks. FDAs responses to the recommendations are detailed in this section. As discussed in detail in sections III and IV below, FDA also considered comments from industry, professional societies, and stakeholders in developing the special controls in this final order. However, here in section II, we specifically address the Panel recommendations and FDAs response.
1. Risks The Panel recommended removing increased risk of cancer recurrence and adverse tissue reaction from the risks to health presented at the Panel meeting.
While surgical stapler malfunctions have resulted in complications such as anastomotic leaks, which have been associated with an increased risk of cancer recurrence, FDA agrees that there is limited evidence directly linking surgical stapler failure or malfunction with an increased risk of cancer recurrence Refs. 2- 4. Therefore, due to the limited evidence directly linking surgical stapler failure or malfunction with an increased risk of cancer recurrence, FDA agrees with removing increased risk of cancer recurrence from the list of complications associated with device failure/malfunction. FDA does not agree that adverse tissue reaction should be removed as a risk to health, as staplers for internal use contain patient-contacting 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, FDA has not removed the applicable special control regarding biocompatibility Ref. 5.
The Panel had specifically been asked to consider additional risks posed by powered staplers that were not identified in the proposed order. The Panel noted that the risks associated with sterility are different for nonpowered staplers, which are generally packaged sterile, and powered staplers, part of which must be reprocessed.

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