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Federal Register / Vol. 86, No. 193 / Friday, October 8, 2021 / Rules and Regulations
TABLE 1RISKS TO HEALTH AND MITIGATION MEASURES FOR SURGICAL STAPLERS FOR INTERNAL USEContinued Identified risks to health
Mitigation measures
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Complications associated with use error/improper device selection and use.
Adverse Tissue Reaction
Infection

FDA modified the special controls to provide additional specificity regarding manual and powered staplers, where appropriate. Specifically, FDA modified the performance testing special controls to include clarification that measurement of worst-case deployment pressures on stapler firing force is applicable only to manual staplers see 878.4740b2iB. FDA added special controls for powered staplers regarding electrical safety, electromagnetic compatibility, software verification, validation, and hazard analysis see 878.4740b2ii and b2iii.
FDA also modified the special controls to refine certain labeling requirements. Specifically, FDA
modified the requirement for a warning regarding establishing and maintaining proximal control of blood vessels prior to stapling to Establishing proximal control of blood vessels prior to stapling where practical see 878.4740b2ixBv. FDA replaced the requirement for a warning regarding appropriate measures to take if a stapler malfunction occurs while applying staples across a blood vessel, such as clamping or ligating the vessel before releasing the stapler, while the stapler is still closed on the tissue with the requirement for a warning regarding methods of blood vessel control in the event of stapler failure. see 878.4740b2ixBv. These edits were made for the reasons described above, including feedback from the Panel and commenters regarding instances where labeling should provide flexibility for a physician to exercise his or her professional judgement. FDA
modified the requirement for a warning regarding avoidance of use of the stapler on large blood vessels, such as the aorta to a warning regarding avoidance of use of the stapler on the aorta see 878.4740b2ixBiv in response to comments that use of the term large blood vessels is vague.
FDA has also revised the special controls to remove the requirement for specific user instructions associated with evaluation of the resultant staple line see 878.4740b2ixC in response to comments that procedures for evaluating staple line integrity may
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Human Factors testing and Labeling.
Biocompatibility evaluation.
Labeling, Sterility testing, and Shelf-Life Testing.

differ depending on different circumstances.
Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability for the final guidance, Surgical Staplers and Staples for Internal UseLabeling Recommendations. FDA made additional revisions in this final order to reflect changes made during finalization of the guidance based on the feedback specifically on that document to the guidance docket. Specifically, FDA
revised the special controls to include a labeling requirement for a warning regarding the risks of crossing staple lines see 878.4740b2ixBvii in response to a comment recommending the addition of such a warning to the guidance. FDA notes that a risk of increased leak rates when staple lines are crossed has been commonly reported in the medical literature Refs.
9 and 10. Therefore, FDA finds that this warning is necessary to mitigate the risks of complications associated with improper device use and to provide a reasonable assurance of the safety and effectiveness of these devices.
In response to a comment recommending removal of the contraindication for stapling of tissues outside the labeled limits of tissue thickness from the guidance, FDA
revised the special controls to change this contraindication to a warning see 878.4740b2ixBi. FDA has changed the contraindication regarding stapling tissues outside the labeled limits for maximum and minimum tissue thickness to a warning instead of a contraindication so as not to impinge on surgeon judgement and since there is currently no standardized mechanism to accurately measure tissue thickness intraoperatively. Nonetheless, FDA
notes that stapling of tissues outside labeled limits has been associated with serious adverse events, such as anastomotic leakage and bleeding, in medical device reports. Therefore, FDA
finds that a warning regarding stapling tissues outside labeled limits is necessary to mitigate the risks of complications associated with improper device use and to provide a reasonable assurance of the safety and effectiveness of these devices.

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FDA also modified the contraindication regarding stapling of necrotic or ischemic tissues to stapling of tissues that are necrotic, friable, or have altered integrity to promote consistency with the language used in the guidance see 878.4740b2ixA. FDA notes that necrotic or ischemic tissues are a subset of tissues that are necrotic, friable, or have altered integrity. As explained above, FDA has determined that the risk of stapling tissues that are necrotic, friable, or have altered integrity outweighs any reasonably foreseeable benefit due to known complications.
FDA is issuing this final order revising 878.4800 by removing the classification of surgical staplers and codifying surgical staplers in the new 21
CFR 878.4740, under which surgical staplers for internal use is classified into class II with special controls and surgical staplers for external use remain in class I, exempt from premarket notification. In this final order, we have identified the special controls under section 513a1B of the FD&C Act that, together with general controls, provide a reasonable assurance of the safety and effectiveness for surgical staplers for internal use.1
FDA may exempt a class II device from the premarket notification requirements, under section 510m 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 devices.
FDA has determined that premarket notification is necessary to provide reasonable assurance of safety and effectiveness of surgical staplers for internal use, and therefore, this device type is not exempt from premarket notification requirements.
The device is assigned the generic name surgical stapler for internal use, 1 FDA notes that the ACTION caption for this final order is styled as Final amendment; final order, rather than Final order. Beginning in December 2019, this editorial change was made to indicate that the document amends the Code of Federal Regulations. The change was made in accordance with the Office of Federal Registers OFR interpretations of the Federal Register Act 44
U.S.C. chapter 15, its implementing regulations 1
CFR 5.9 and parts 21 and 22, and the Document Drafting Handbook.

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