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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 060 Date of Entry 05/29/2023 
FR Recognition Number 8-602
Standard
ASTM  F2503-23
Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
Scope/Abstract
1.1 This practice applies to medical devices and other items that are anticipated to enter the magnetic resonance (MR) environment.

1.2 The practice specifies the marking of items anticipated to enter the MR environment by means of terms and icons, and recommends information that should be included in the labeling.

1.3 MR image artifacts are not in the scope of the mandatory portions of this practice because they do not present a direct safety issue resulting from specific characteristics of the
MR examination (see X1.12).

NOTE 1-"Medical devices and other items" will be referred to as "items" for the remainder of this practice.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Transition Period
FDA recognition of ASTM F2503-20 [Rec# 8-528] will be superseded by recognition of ASTM F2503-23 [Rec# 8-602]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 8-528] until July 5, 2026. After this transition period, declarations of conformity to [Rec# 8-528] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
21 CFR Part 801 Labeing, medical devices, reporting and recordkeeping requirements.
21 CFR Part 809 Labeling, medical devices.
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and Food and Drug Administration Staff: Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment, Issued May 2021.

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 Contacts
 Terry O. Woods
  FDA/OC/CDRH/OSPTI/ORR/DSCA
  301-796-2503
  terry.woods@fda.hhs.gov
 Vasant Dasika
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-5365
  Vasant.Dasika@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Materials
*These are provided as examples and others may be applicable.
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