Voglio sapere a riguardo di…

jspears on DSK121TN23PROD with RULES1

Federal Register / Vol. 86, No. 222 / Monday, November 22, 2021 / Rules and Regulations sequences, rationale for the selected epitopes, degree of amino acid sequence conservation of the target, and the design and nature of all primary, secondary, and subsequent standards used for calibration.
ii Documentation and characterization e.g., supplier, determination of identity, and stability of all critical reagents including description of the antigens and capture antibodyies, and protocols for maintaining product integrity throughout its labeled shelf life.
iii Risk analysis and management strategies, such as Failure Modes Effects Analysis and/or Hazard Analysis and Critical Control Points summaries and their impact on test performance.
iv Final release criteria to be used for manufactured test lots with appropriate evidence that lots released at the extremes of the specifications will meet the claimed analytical and clinical performance characteristics as well as the stability claims.
v Stability studies for reagents must include documentation of an assessment of real-time stability for multiple reagent lots using the indicated specimen types and must use acceptance criteria that ensure that analytical and clinical performance characteristics are met when stability is assigned based on the extremes of the acceptance range.
vi All stability protocols, including acceptance criteria.
vii Final release test results for each lot used in clinical studies.
viii Multisite reproducibility study that includes the testing of three independent production lots.
ix Analytical performance studies and results for determining the limit of blank LoB, limit of detection LoD, cutoff, precision reproducibility including lot-to-lot and/or instrumentto-instrument precision, interference, cross reactivity, carryover, hook effect, seroconversion panel testing, matrix equivalency, specimen stability, reagent stability, and cross-genotype antibody detection sensitivity, when appropriate.
x Analytical sensitivity of the test is the same or better than that of other cleared or approved tests.
xi Detailed documentation of clinical performance testing from a multisite clinical study. Performance must be analyzed relative to an FDA
cleared or approved HCV antibody test, or a comparator that FDA has determined is appropriate. This study must be conducted using appropriate patient samples, with an acceptable number of HCV positive and negative samples in applicable risk categories.
Additional relevant patient groups must be validated as appropriate. The
VerDate Sep<11>2014

17:19 Nov 19, 2021

Jkt 256001

samples may be a combination of fresh and repository samples, sourced from geographically diverse areas. The study designs, including number of samples tested, must be sufficient to meet the following criteria:
A Clinical sensitivity of the test must have a lower bound of the 95
percent confidence interval of greater than or equal to 95 percent.
B Clinical specificity of the test must have a lower bound of the 95 percent confidence interval of greater than or equal to 96 percent.
3 For any HCV antibody test intended for Point of Care PoC use, the following special controls, in addition to those listed in paragraphs b1 and 2 of this section, apply:
i Clinical studies must be conducted at PoC sites.
ii Additional labeling must include a brief summary of the instructions for use that are appropriate for use in a PoC
environment.
Dated: November 16, 2021.
Lauren K. Roth, Associate Commissioner for Policy.
FR Doc. 202125374 Filed 111921; 8:45 am BILLING CODE 416401P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration 21 CFR Part 878
Docket No. FDA2016M0035

Effective Date of Requirement for Premarket Approval for Blood Lancets AGENCY:

Food and Drug Administration,
HHS.
ACTION:

Final order.

The Food and Drug Administration FDA, Agency, or we is issuing a final order to require the filing of a premarket approval application PMA or notice of completion of a product development protocol PDP
following the reclassification of multiple use blood lancets for multiple patient use from class I to class III.
DATES: This order is effective on November 22, 2021.
FOR FURTHER INFORMATION CONTACT:
Rebecca Nipper, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1540, Silver Spring, MD 209930002, 3017966527, rebecca.nipper@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:

PO 00000

Frm 00023

Fmt 4700

Sfmt 4700

66177

I. Background The Federal Food, Drug, and Cosmetic Act FD&C Act, as amended, establishes a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the FD&C
Act 21 U.S.C. 360c established three categories classes of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I general controls, class II special controls, and class III premarket approval.
Under section 513d1 of the FD&C
Act, devices that were in commercial distribution before the enactment of the Medical Device Amendments of 1976
the 1976 amendments Pub. L. 94
295, May 28, 1976 generally referred to as preamendments devices, are classified after FDA: 1 Receives a recommendation from a device classification panel an FDA advisory committee; 2 publishes the panels recommendation for comment, along with a proposed regulation classifying the device; and 3 publishes a final regulation classifying the device. FDA
has classified most preamendments devices under these procedures.
A preamendments device that has been classified into class III and devices found substantially equivalent by means of premarket notification 510k procedures to such a preamendments device or to a device within that type both the preamendments and substantially equivalent devices are referred to as preamendments class III
devices may be marketed without submission of a PMA until FDA issues a final order under section 515b of the FD&C Act 21 U.S.C. 360eb requiring premarket approval. Section 515b1 of the FD&C Act directs FDA to issue an order requiring premarket approval for a preamendments class III device.
Section 515f of the FD&C Act provides an alternative pathway for meeting the premarket approval requirement. Under section 515f, manufacturers may meet the premarket approval requirement if they file a notice of completion of a PDP approved under section 515f4 of the FD&C Act and FDA declares the PDP completed under section 515f6B of the FD&C
Act. Accordingly, the manufacturer of a preamendments class III device may comply with a call for PMAs by filing a PMA or a notice of completion of a PDP. In practice, however, the option of filing a notice of completion of a PDP
has rarely been used. For simplicity, although the PDP option remains available to manufacturers in response to a final order under section 515b of
E:FRFM22NOR1.SGM

22NOR1