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Federal Register / Vol. 86, No. 193 / Friday, October 8, 2021 / Rules and Regulations
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and it is identified as a specialized prescription device used to deliver compatible staples to internal tissues during surgery for resection, transection, and creating anastomoses.
V. Implementation Strategy The order is effective on its date of publication in the Federal Register.
Surgical staplers for internal use that have not been offered for sale prior to the effective date of the final order or have been offered for sale but are required to submit a new 510k under 21 CFR 807.81a3: Manufacturers would have to obtain 510k clearance before marketing their devices after the effective date of the order. If a manufacturer markets such a device without receiving 510k clearance, then FDA would consider taking action against such a manufacturer under its usual enforcement authorities and policies.
Surgical staplers for internal use that have been offered for sale prior to the effective date of the final order and do not already have 510k clearance:
FDA does not intend to enforce compliance with the 510k requirement or special controls until 180 days after the effective date of the final order.
After that date, if a manufacturer continues to market such a device but does not have 510k clearance or FDA
determines that the device is not substantially equivalent or not compliant with special controls, then FDA would consider taking action against such manufacturer under its usual enforcement authorities and policies.
For surgical staplers for internal use that have prior 510k clearance, FDA
would accept a new 510k and would issue a new clearance letter, as appropriate, indicating substantial equivalence and special controls compliance. These devices could serve as predicates for new devices. These clearance letters would be made publicly available in FDAs 510k database, and compliance with special controls at the time of clearance would also be stated in the publicly available 510k Summary posted in this database.
FDA notes that our public database is a transparent tool allowing users to confirm that their devices have been submitted under a new 510k and demonstrated conformance to applicable special controls.
VI. Analysis of Environmental Impact We have determined under 21 CFR
25.34b that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an
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environmental assessment nor an environmental impact statement is required.
VII. Paperwork Reduction Act of 1995
This administrative order establishes special controls that refer to previously approved collections of information found in other FDA regulations and guidance. Those collections of information are subject to review by the Office of Management and Budget OMB under the Paperwork Reduction Act of 1995 PRA 44 U.S.C. 3501
3521. The collections of information in 21 CFR part 807, subpart E, have been approved under OMB control number 09100120; the collections of information in 21 CFR part 820 have been approved under OMB control number 09100073; and the collections of information under 21 CFR part 801
have been approved under OMB control number 09100485.
VIII. Codification of Orders Prior to the amendments by FDASIA, section 513e of the FD&C Act provided for FDA to issue regulations to reclassify devices. Although section 513e as amended requires FDA to issue final orders rather than regulations, it also provides for FDA to revoke previously issued regulations by order. FDA will continue to codify classifications and reclassifications in the Code of Federal Regulations CFR. Changes resulting from final orders will appear in the CFR
as changes to codified classification determinations or as newly codified orders. Therefore, under section 513e1Ai, as amended by FDASIA, in the final order, we are revising 21
CFR 878.4800 to remove the classification of surgical staplers and codifying surgical staplers in the new 21
CFR 878.4740, under which surgical staplers for internal use would be reclassified into class II and surgical staplers for external use would remain in class I, exempt from premarket notification.
IX. References The following references marked with an asterisk are on display at the Dockets Management Staff HFA305, Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852, 2404027500; and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they also are available electronically at https
www.regulations.gov. References without asterisks are not on public display at https www.regulations.gov because they have copyright restriction.
Some may be available at the website
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address, if listed. References without asterisks are available for viewing only at the Dockets Management Staff. FDA
has verified the website addresses, as of the date this document publishes in the Federal Register, but websites are subject to change over time.
1. FDA, May 30, 2019, Meeting of the General and Plastic Surgery Devices Panel Meeting Materials available at https www.fda.gov/advisorycommittees/advisory-committeecalendar/may-30-31-2019-general-andplastic-surgery-devices-panel-medicaldevices-advisory-committee-meeting.
2. Folkesson, J., J. Nilsson, L. Pahlman, et al., The Circular Stapling Device as a Risk Factor for Anastomotic Leakage.
Colorectal Disease. 2004 July; 64:275
9.
3. Ouchi, A., A. Masahiko, K. Aono, et al., Staple-Line Recurrence Arising 10
Years After Functional End-to-End Anastomosis for Colon Cancer: A Case Report. Surgical Case Reports. 2015
December; 1:7.
4. Hsu, T.C. and M.J. Chen, Presence of Colon Carcinoma Cells at the Resection Line May Cause Recurrence Following Stapling Anastomosis. Asian Journal of Surgery. 2018 November; 416:569572.
5. Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 109931, Biological Evaluation of Medical DevicesPart 1: Evaluation and Testing Within a Risk Management Process,
September 4, 2020, available at: https
www.fda.gov/regulatory-information/
search-fda-guidance-documents/useinternational-standard-iso-10993-1biological-evaluation-medical-devicespart-1-evaluation-and.
6. Guidance for Industry and FDA Staff:
The Least Burdensome Provisions:
Concept and Principles, February 5, 2019, available at: https www.fda.gov/
regulatory-information/search-fdaguidance-documents/least-burdensomeprovisions-concept-and-principles.
7. FDA, March 8, 2019, Letter to Health Care Providers, Safe Use of Surgical Staplers and Staples, available at: https
www.fda.gov/medical-devices/lettershealth-care-providers/safe-use-surgicalstaplers-and-staples-letter-health-careproviders.
8. Guidance for Industry and Food and Drug Administration Staff: Deciding When to Submit a 510k for a Change to an Existing Device, October 25, 2017, available at: https www.fda.gov/
regulatory-information/search-fdaguidance-documents/deciding-whensubmit-510k-change-existing-device.
9. Lee, S., B. Ahn, and S. Lee, The Relationship Between the Number of Intersections of Staple Lines and Anastomotic Leakage After the Use of a Double Stapling Technique in Laparoscopic Colorectal Surgery.
Surgical Laparoscopy, Endoscopy &
Percutaneous Techniques. 2017 August;
274:273281.
10. Crafa, F., J. Megevand, G. Romano, and P. Sileri, New Double-Stapled
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