FDA Recognized Consensus Standards

$179 / year

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.

Complexity

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.

Date Created

2016

Last Modified

2019-12-23

Version

2019-12-23

Update Frequency

Quarterly

Temporal Coverage

2016-2019

Spatial Coverage

United States

Source

John Snow Labs; U.S. Food and Drug Administration (FDA);

Source License URL

Source License Requirements

N/A

Source Citation

N/A

Keywords

FDA Recognized Standards, Device Standards Database, MD Standards, Medical Devices

Other Titles

FDA Medical Device Standards, FDA Recognized Standards, US Recognized Consensus Standards

NameDescriptionTypeConstraints
Standard_Designation_Number_And_DateStandard designation number and datestringrequired : 1
Standard_TitleThe title of the FDA standardstringrequired : 1
Specialty_Task_GroupSpecialty task groupstringrequired : 1
FR_Publication_DateFederal regulations publication datedaterequired : 1
Standard_Developing_OrganizationThe Standard developing organization, more than 30 organizations are included.stringrequired : 1
Standard_DescriptionThe Description of the FDA standardstring-
Standard Designation Number And DateStandard TitleSpecialty Task GroupFR Publication DateStandard Developing OrganizationStandard Description
6474-2 Second edition 2019-03Implants for surgery - Ceramic materials - Part 2: Composite materials based on a high-purity alumina matrix with zirconia reinforcementMaterials2019-12-23ISO 8-505
F2101-14Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials Using a Biological Aerosol of Staphylococcus aureusGeneral Plastic Surgery/General Hospital2015-01-27ASTM 6-335
42-NF37:2019Nonabsorbable Surgical SutureGeneral Plastic Surgery/General Hospital2019-12-23USP 6-430
42-NF37:2019<871> Sutures - Needle AttachmentGeneral Plastic Surgery/General Hospital2019-12-23USP 6-433
7206-10 Second edition 2018-08Implants for surgery - Partial and total hip-joint prostheses - Part 10: Determination of resistance to static load of modular femoral headsOrthopedic2019-07-15ISO 11-359
11073-90101 First edition 2008-01-15Health informatics - Point-of-care medical device communication - Part 90101: Analytical instruments -- Point-of-care testSoftware/Informatics2014-07-09ISO 13-68
11073-91064 First edition 2009-05-01Health informatics - Standard communication protocol - Computer-assisted electrocardiographySoftware/Informatics2015-08-14ISO 13-76
Std 11073-10419:2015Health informatics - Personal health device communication - Part 10419: Device Specialization - Insulin PumpSoftware/Informatics2016-04-04IEEE 13-81
62274 First Edition 2005-05Medical electrical equipment - Safety of radiotherapy record and verify systemsRadiology2012-03-16IEC 12-241
60601-2-11 Edition 3.0 2013-01Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipmentRadiology2013-08-06IEC 12-255