- 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.
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|
|6474-2 Second edition 2019-03||Implants for surgery - Ceramic materials - Part 2: Composite materials based on a high-purity alumina matrix with zirconia reinforcement||Materials||2019-12-23||ISO||8-505|
|F2101-14||Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials Using a Biological Aerosol of Staphylococcus aureus||General Plastic Surgery/General Hospital||2015-01-27||ASTM||6-335|
|42-NF37:2019||Nonabsorbable Surgical Suture||General Plastic Surgery/General Hospital||2019-12-23||USP||6-430|
|42-NF37:2019||<871> Sutures - Needle Attachment||General Plastic Surgery/General Hospital||2019-12-23||USP||6-433|
|7206-10 Second edition 2018-08||Implants for surgery - Partial and total hip-joint prostheses - Part 10: Determination of resistance to static load of modular femoral heads||Orthopedic||2019-07-15||ISO||11-359|
|11073-90101 First edition 2008-01-15||Health informatics - Point-of-care medical device communication - Part 90101: Analytical instruments -- Point-of-care test||Software/Informatics||2014-07-09||ISO||13-68|
|11073-91064 First edition 2009-05-01||Health informatics - Standard communication protocol - Computer-assisted electrocardiography||Software/Informatics||2015-08-14||ISO||13-76|
|Std 11073-10419:2015||Health informatics - Personal health device communication - Part 10419: Device Specialization - Insulin Pump||Software/Informatics||2016-04-04||IEEE||13-81|
|62274 First Edition 2005-05||Medical electrical equipment - Safety of radiotherapy record and verify systems||Radiology||2012-03-16||IEC||12-241|
|60601-2-11 Edition 3.0 2013-01||Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment||Radiology||2013-08-06||IEC||12-255|