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

2019-07-15

Version

2019-07-15

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
F2224-09 (Reapproved 2014)Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical ImplantsMaterials2016-06-27ASTM 8-429
14243-2 Third edition 2016-09-01Implants for surgery - Wear of total knee-joint prostheses - Part 2: Methods of measurementOrthopedic2016-12-23ISO 11-311
D6355-07 (Reapproved 2017)Standard Test Method for Human Repeat Insult Patch Testing of Medical GlovesGeneral Plastic Surgery/General Hospital2018-06-07ASTM 6-214
ST72:2011/(R)2016Bacterial endotoxins - Test methods routine monitoring and alternatives to batch testingSterility2016-12-23ANSI AAMI 14-360
D6977-04 (Reapproved 2016)Standard Specification for Polychloroprene Examination Gloves for Medical ApplicationGeneral Plastic Surgery/General Hospital2016-12-23ASTM 6-165
80601-2-70 First Edition 2015-01-15Medical Electrical Equipment - Part 2-70: Particular Requirements for Basic Safety and Essential Performance of Sleep Apnoea Breathing Therapy EquipmentAnesthesiology2016-04-04ISO 1-115
F719-81 (Reapproved 2012)Standard Practice for Testing Biomaterials in Rabbits for Primary Skin IrritationBiocompatibility2016-07-26ASTM 2-122
F1089-18Standard Test Method for Corrosion of Surgical InstrumentsMaterials2018-09-17ASTM 8-478
MS 3-2008 (R2014)Determination of Image Uniformity in Diagnostic Magnetic Resonance ImagesRadiology2016-04-04NEMA 12-187
21563 First edition 2013-08-15Dentistry - Hydrocolloid impression materialsDental/ENT2018-06-07ISO 4-240