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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 034 Date of Entry 01/30/2014 
FR Recognition Number 7-244
CLSI  NBS01-A6 (Replaces LA04-A5)
Blood Collection on Filter Paper for Newborn Screening Programs: Approved Standard - Sixth Edition
This document highlights specimen collection methods, discusses acceptable techniques for applying blood drops or aliquots to the filter paper segment of the specimen collection device, and provides instructions on proper specimen handling and transport to ensure quality specimens are consistently obtained for newborn screening analysis.
Extent of Recognition
Complete standard
Transition Period
FDA recognition of CLSI NBS01-A6 (Replaces LA04-A5) [Rec# 7-244] will be superseded by recognition of CLSI NBS01 7th Edition [Rec# 7-316]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 7-244] until July 6, 2025. After this transition period, declarations of conformity to [Rec# 7-244] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§862.1675 Tubes, Vials, Systems, Serum Separators, Blood Collection Class 2 JKA
Relevant FDA Guidance and/or Supportive Publications*
Points to Consider for Consider for Collection of Data in Support of In-Vitro Device Submissions for 510(k) Clearance, Issued September 1994.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Kellie Kelm
Standards Development Organization
CLSI Clinical Laboratory Standards Institute https://clsi.org/
FDA Specialty Task Group (STG)
InVitro Diagnostics
*These are provided as examples and others may be applicable.