Federal Register - November 22, 2021
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Source: Federal Register
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Federal Register / Vol. 86, No. 222 / Monday, November 22, 2021 / Rules and Regulations
jspears on DSK121TN23PROD with RULES1
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 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 Guidance for Industry and FDA
Staff, Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use, September 2020, available at https
www.fda.gov/regulatory-information/
search-fda-guidance-documents/selfmonitoring-blood-glucose-test-systemsover-counter-use.
2. Executive Summary, Transcript and other meeting material of the June 26, 2013, meeting of the General and Plastic Surgery Devices Panel available at https wayback.archive-it.org/7993/
20170405193132/https:/www.fda.gov/
AdvisoryCommittees/CommitteesMeeting Materials/MedicalDevices/
MedicalDevicesAdvisoryCommittee/
GeneralandPlasticSurgeryDevicesPanel/
ucm349426.htm.
3. FDA Guidance for Industry and FDA
Staff, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, March 17, 2015, available at https www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/reprocessing-medicaldevices-health-care-settings-validationmethods-and-labeling.
4. FDA Guidance for Industry and FDA
Staff, Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use, September 2020, available at https www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/blood-glucose-monitoringtest-systems-prescription-point-care-use.
5. The World Health Organization WHO
Guidelines on Drawing Blood: Best Practices in Phlebotomy, Part II, 2, Geneva: World Health Organization, 2010, available at https
www.ncbi.nlm.nih.gov/books/
NBK138665/.
6. Clinical Laboratory Standards Institute CLSI, GP42 7th Edition, Collection of Capillary Blood Specimens.
7. FDA Guidance for Industry and FDA
Staff, Submission and Review of Sterility Information in Premarket Notification 510k Submissions for Devices Labeled as Sterile, January 21, 2016, available at https www.fda.gov/
regulatory-information/search-fdaguidance-documents/submission-and-
VerDate Sep<11>2014
17:19 Nov 19, 2021
Jkt 256001
review-sterility-information-premarketnotification-510k-submissions-deviceslabeled.
8. FDA Guidance for Industry and FDA
Staff, Use of International Standard ISO
109931, Biological Evaluation of Medical DevicesPart 1: Evaluation and Testing Within a Risk Management Process, September 2020, available at https www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/use-international-standardiso-10993-1-biological-evaluationmedical-devices-part-1-evaluation-and.
9. Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff Class II 510k Exemption Guidance, February 19, 1998, available at https www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/procedures-class-ii-deviceexemptions-premarket-notificationguidance-industry-and-cdrh-staff.
10. FDA Guidance for Industry and FDA
Staff, Bundling Multiple Devices or Multiple Indications in a Single Submission, June 20, 2007, available at https www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/bundling-multiple-devicesor-multiple-indications-singlesubmission.
List of Subjects in 21 CFR Part 878
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 878 is amended as follows:
PART 878GENERAL AND PLASTIC
SURGERY DEVICES
1. The authority citation for part 878
continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
2. Amend 878.4800 by revising paragraph a to read as follows:
878.4800 Manual surgical instrument for general use.
a Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle,
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osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868
through 892 of this chapter.
3. Add 878.4850 to subpart E to read as follows:
878.4850
Blood lancets.
a Single use only blood lancet with an integral sharps injury prevention feature1 Identification. A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base including an integral sharps injury prevention feature that is used to puncture the skin to obtain a drop of blood for diagnostic purposes. The integral sharps injury prevention feature allows the device to be used once and then renders it inoperable and incapable of further use.
2 Classification. Class II special controls. The special controls are:
i The design characteristics of the device must ensure that the structure and material composition are consistent with the intended use and must include a sharps injury prevention feature.
ii Mechanical performance testing must demonstrate that the device will withstand forces encountered during use and that the integral sharps injury prevention feature will irreversibly disable the device after one use.
iii The device must be demonstrated to be biocompatible.
iv Sterility testing must demonstrate the sterility of any device component that breaches the skin e.g., blade.
v Labeling must include:
A Detailed descriptions, with illustrations, of the proper use of the device and its sharps injury prevention feature.
B Handwashing instructions for the user before and after use of the device.
C Instructions on preparation e.g., cleaning, disinfection of the skin to be pierced.
D Instructions for the safe disposal of the device.
E Labeling must be appropriate for the intended use environment.
1 For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.
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