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
3 Date PMA or notice of completion of a PDP is required: A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 22, 2024, for any multiple use blood lancet for multiple patient use described in paragraph d1 of this section that was in commercial distribution before May 28, 1976, or that has, on or before May 22, 2024, been found to be substantially equivalent to a multiple use blood lancet for multiple patient use described in paragraph d1 of this section that was in commercial distribution before May 28, 1976. Any other multiple use blood lancet for multiple patient use shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
Dated: November 16, 2021.
Lauren K. Roth, Associate Commissioner for Policy.
FR Doc. 202125381 Filed 111921; 8:45 am BILLING CODE 416401P
Food and Drug Administration 21 CFR Part 878
Docket No. FDA2016N0400
Medical Devices; General and Plastic Surgery Devices; Reclassification of Blood Lancets Food and Drug Administration, Department of Health and Human Services HHS.
ACTION: Final amendment; final order.
AGENCY:
The Food and Drug Administration FDA or the Agency is issuing a final order to reclassify three types of blood lancets used to puncture skin to obtain a drop of blood for diagnostic purposes from class I general controls exempt from premarket notification into class II special controls and subject to premarket notification, specifically, single use only blood lancets with an integral sharps injury prevention feature, single use only blood lancets without an integral sharps injury prevention feature, and multiple use blood lancets for single patient use only. FDA is designating special controls for these three types of blood lancets based on the determination that general controls only are not sufficient and there is sufficient information to establish special controls to provide a reasonable assurance of their safety and effectiveness. FDA is also reclassifying a fourth type of blood lancet, multiple use blood lancets for
SUMMARY:
multiple patient use, from class I
general controls exempt from premarket notification into class III
premarket approval. FDA is reclassifying these four types of blood lancets on its own initiative based on new information.
DATES: This order is effective November 22, 2021. See further discussion in section VI, Implementation Strategy.
FOR FURTHER INFORMATION CONTACT:
Rebecca Nipper, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 1540, Silver Spring, MD 20993, 301796
6527, Rebecca.Nipper@fda.hhs.gov; or Stephen Ripley, Center for Biologics Evaluation and Research, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240402
7911, Stephen.Ripley@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
Table of Contents I. Table of Abbreviations/Commonly Used Acronyms in This Document II. Background A. Classification B. Reclassification C. Requirement for Premarket Approval III. Public Comments in Response to the Proposed Order IV. The Final Order V. Premarket Notification Requirement for Single Patient Use Only Blood Lancets VI. Implementation Strategy VII. Codification of Orders VIII. Analysis of Environmental Impact IX. Paperwork Reduction Act of 1995
X. References
I. Table of Abbreviations/Commonly Used Acronyms in This Document
Abbreviation or acronym
What it means
510k
515b Proposed Order
Premarket Notification.
Proposed Order calling for premarket approval applications for class III blood lancets published on March 3, 2016 81 FR 11151.
Proposed Order to reclassify blood lancets published on March 3, 2016 81 FR 11140.
Food and Drug Administration.
Centers for Disease Control and Prevention.
Code of Federal Regulations.
Environmental Protection Agency.
Food and Drug Administration.
Food and Drug Administration Safety and Innovation Act.
Federal Food, Drug, and Cosmetic Act.
Federal Register.
Human Immunodeficiency Virus.
Office of Management and Budget.
General & Plastic Surgery Devices Panel of the Medical Devices Advisory Committee, device classification panel on June 26, 2013.
Product Development Protocol.
Premarket Approval Application.
Paperwork Reduction Act of 1995.
Prothrombin Time and International Normalized Ratio.
Reference.
Unique Device Identifier.
Universal Product Code.
United States Code.
513e Proposed Order
Agency
CDC
CFR
EPA
FDA
FDASIA
FD&C Act
FR
HIV
OMB
Panel
jspears on DSK121TN23PROD with RULES1
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
PDP
PMA
PRA
PT/INR
Ref
UDI
UPC
U.S.C
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