- 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|
|MM13 2nd Edition||Collection Transport Preparation and Storage of Specimens for Molecular Methods||InVitro Diagnostics||2020-12-21||CLSI||7-300|
|C34 4th Edition||Sweat Testing: Specimen Collection and Quantitative Chloride Analysis||InVitro Diagnostics||2020-12-21||CLSI||7-302|
|F3044-20||Standard Test Method for Evaluating the Potential for Galvanic Corrosion for Medical Implants||Materials||2020-12-21||ASTM||8-546|
|F629-20||Standard Practice for Radiography of Cast Metallic Surgical Implants||Materials||2020-12-21||ASTM||8-547|
|3B 2017||Packaged-Products for Less-Than-Truckload (LTL) Shipment||General I (QS/RM)||2020-07-06||ISTA||5-127|
|3E 2017||Similar Packaged-Products in Unitized Loads of Truckload Shipment||General I (QS/RM)||2020-07-06||ISTA||5-128|
|52903-1 First edition 2020-04||Additive manufacturing - Material extrusion-based additive manufacturing of plastic materials - Part 1: Feedstock materials||Materials||2020-12-21||ASTM ISO||8-553|
|62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION||Medical devices - Part 1: Application of usability engineering to medical devices||General I (QS/RM)||2020-07-06||IEC||5-129|
|Standard No. 88-2019||Dental Brazing Alloys||Dental/ENT||2020-12-21||ANSI ADA||4-264|
|F2503-20||Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment||Materials||2020-07-06||ASTM||8-528|