- FDA Medical Device Standards
- FDA Recognized Standards
- US Recognized Consensus Standards
- FDA Recognized Standards
- Device Standards Database
- MD Standards
- Medical Devices
FDA Recognized Consensus Standards
FDA Recognized Consensus Standards database consists of those national and international standards recognized by FDA which manufacturers can declare conformity to and is part of the information the Center can use to make an appropriate decision regarding the clearance or approval of a submission.
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FDA Recognized Consensus Standards database includes standards recognized by FDA and used to make an appropriate decision regarding the clearance or approval of a submission.
Information submitted on conformance with such standards will have a direct bearing on safety and effectiveness determinations made during the review of IDEs, HDEs, PMAs, and PDPs. Conformance with recognized consensus standards in and of itself, however, may not always be a sufficient basis for regulatory decisions.
Many domestic and international consensus standards address aspects of safety and/or effectiveness relevant to medical devices. Many of these standards have been developed with the participation of Center for Devices and Radiological Health (CDRH) staff.
CDRH believes that conformance with recognized consensus standards can support a reasonable assurance of safety and/or effectiveness for many applicable aspects of medical devices. Therefore, information submitted on conformance with such standards should have a direct bearing on safety and effectiveness determinations made during the review of investigational device exemption (IDEs), Humanitarian Device Exemption (HDEs), Premarket approval (PMAs), and Product Development Protocol (PDPs). In 510(k)s, information on conformance with recognized consensus standards may help establish the substantial equivalence of a new device to a legally marketed predicate device.
These information may be used to show that the new device is as safe and effective as the predicate in the areas covered by the standards.
Conformance with recognized consensus standards may not always be a sufficient basis for regulatory decisions. For example, a specific device may raise a safety or effectiveness issue not addressed by any recognized consensus standard, or a specific FDA regulation may require additional information beyond what conformity to the recognized consensus standards provides. Under such circumstances, conformity with recognized standards will not satisfy all requirements for marketing, or investigating, the product in the United States.
About this Dataset
John Snow Labs; U.S. Food and Drug Administration (FDA);
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FDA Recognized Standards, Device Standards Database, MD Standards, Medical Devices
FDA Medical Device Standards, FDA Recognized Standards, US Recognized Consensus Standards
|Standard_Designation_Number_And_Date||Standard designation number and date||string||required : 1|
|Standard_Title||The title of the FDA standard||string||required : 1|
|Specialty_Task_Group||Specialty task group||string||required : 1|
|FR_Publication_Date||Federal regulations publication date||date||required : 1|
|Standard_Developing_Organization||The Standard developing organization, more than 30 organizations are included.||string||required : 1|
|Standard_Description||The Description of the FDA standard||string||-|
|Standard Designation Number And Date||Standard Title||Specialty Task Group||FR Publication Date||Standard Developing Organization||Standard Description|
|S3.2-2020||American National Standard Method for Measuring the Intelligibility of Speech over Communication Systems||Dental/ENT||2021-06-07||ANSI ASA||4-274|
|Standard No. 37-1986 (R2020)||Dental Abrasive Powders||Dental/ENT||2021-12-20||ANSI ADA||4-285|
|20417 First edition 2021-04 Corrected version 2021-12||Medical devices - Information to be supplied by the manufacturer||General I (QS/RM)||2022-02-07||ISO||15-135|
|M99670_02_01||<881> Tensile Strength||General Plastic Surgery/General Hospital||2021-12-20||USP-NF||6-468|
|M80190_04_01||Absorbable Surgical Suture||General Plastic Surgery/General Hospital||2021-12-20||USP-NF||6-473|
|M98810_01_01||<71> Sterility Tests||Sterility||2021-12-20||USP-NF||14-569|
|F1586-21||Standard Specification for Wrought Nitrogen Strengthened 21 Chromium-10 Nickel-3 Manganese-2.5 Molybdenum Stainless Steel Bar for Surgical Implants (UNS S31675)||Materials||2021-12-20||ASTM||8-568|
|62127-1 Edition 2.0 2022-03||Ultrasonics - Hydrophones - Part 1: Measurement and characterization of medical ultrasonic fields||Radiology||2022-05-30||IEC||12-343|
|10993-12 Fifth edition 2021-01||Biological evaluation of medical devices - Part 12: Sample preparation and reference materials||Biocompatibility||2021-06-07||ISO||2-289|
|23089-2 First edition 2021-05||Implants for surgery - Preclinical mechanical assessment of spinal implants and particular requirements - Part 2: Spinal intervertebral body fusion devices||Orthopedic||2021-12-20||ISO||11-390|