FDA Recognized Consensus Standards

$79 / 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

2018-05-14

Version

2018-05-14

Update Frequency

Quarterly

Temporal Coverage

N/A

Spatial Coverage

United States

Source

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

Source License URL

John Snow Labs Standard License

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

Name Description Type Constraints
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
/AMS2750 Rev. E 2012-07PyrometryMaterials2017-08-21SAE 8-459
40-NF35:2017<71> Sterility TestsSterility2017-08-21USP 14-504
XR 25Computed Tomography Dose CheckRadiology2011-03-18NEMA 12-225
ST8:2013Hospital steam sterilizersSterility2014-01-30ANSI AAMI 14-406
RT2:2017Radiation therapy readiness checkRadiology2017-12-04AAMI 12-307
40-NF35:2017<85> Bacterial Endotoxins TestSterility2017-08-21USP 14-505
1642 5th EditionLithium Batteries General II (ES/EMC)2014-07-09UL 19-10
Z80.7-2013Ophthalmics - Intraocular LensesOphthalmic2014-01-30ANSI 10-89
Standard No.119-2015Manual ToothbrushesDental/ENT2017-08-21ANSI ADA 4-236
Standard No.139-2012Dental Base PolymersDental/ENT2017-08-21ANSI ADA 4-234