Recognized Consensus Standards: Medical Devices

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Explanation of search fields

Standards Organization: Standards development organization (SDO) which published the standard, e.g., AAMI, CLSI, ISO.

Standard Designation Number: The unique identifier of the published document, limited to a search of the designation number field, without the SDO abbreviation, e.g., 14971, 60601-1, D3577.

Recognition Number: Unique ID of the recognized standard, grouped by STG, of the format XX-YYY, e.g., 3-123.

Keywords: Word or phrase to be searched for, found anywhere on the Supplementary Information Sheet (SIS) of the recognized standard.

Included in ASCA? Check box for list of standards included in the Accreditation Scheme for Conformity Assessment.

Specialty Task Group Area: The number assigned to each Specialty Task Group (STG) forms the first part of the recognition number, e.g., 3 for Cardiology STG in the recognition # 3-123.

Product Code: The SIS for most vertical standards, e.g., product-specific standards, includes a list of relevant product codes for which the standard may be applicable. The Product Code assigned to a device is based upon the medical device product classification designated under 21 CFR Parts 862-892. For more information on FDA Product Codes, please visit Product Classification Database | FDA.

Regulation Number: Part and Section of the Title 21 regulation to be searched for, in the format Part.Section (e.g., 888.1111).

Date of Entry: Date of initial SIS entry into the database. Use the date picker or enter dates using format mm/dd/yyyy.

Sort: The default sort order of the Results is from newest to oldest Date of Entry. Other options are listed in the drop-down.

No records were found. What next?

1. Try entering the information in the "Keywords" search box in case the standard or other document is referenced on another Supplementary Information Sheet (SIS).

2. Refer to the Table of Non-Recognized Standards for a listing of standards that have been assessed and where a decision was made to not recognize the standard.

3. If you believe the standard of interest is currently recognized by FDA, but is not found, please contact CDRH Standards Staff at CDRHStandardsStaff@fda.hhs.gov.

4. If you are unable to locate the standard of interest, and you would like FDA to consider it as a candidate for recognition, please visit FDA Standards Recognition Process to learn how to make a formal request.

5. For more information on ASCA, please visit Accreditation Scheme for Conformity Assessment (ASCA) | FDA.