Medical Devices Classification

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The Medical Devices classification Database dataset contains medical device names and associated information developed by the Center for Devices and Radiological Health (CDRH) in support of its mission.

Complexity

The Medical Devices Classification dataset contains device names and their associated product codes. The name and product code identify the generic category of a device for FDA. The Product Code assigned to a device is based upon the medical device product classification designated under 21 CFR Parts 862-892.

The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of devices and grouped them into 16 medical specialties referred to as panels. Each of these generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device.

The three classes and the requirements which apply to them are:

1. Class I General Controls: With Exemptions or Without Exemptions.
2. Class II General Controls and Special Controls: With Exemptions or Without Exemptions.
3. Class III General Controls and Premarket Approval

Date Created

2014-06

Last Modified

2018-10-28

Version

2018-10-28

Update Frequency

Weekly

Temporal Coverage

N/A

Spatial Coverage

United States

Source

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

Source License URL

John Snow Labs Standard License

Source License Requirements

N/A

Source Citation

N/A

Keywords

Medical Devices Classification, Device Classification Panels, Product Code, Medical Devices Classification Database, Product Devices Code Identify

Other Titles

Product Code Classification Database, Device Classification Product Code

Name Description Type Constraints
Review_PanelReview PanelstringmaxLength : 2
Medical_SpecialtyMedical specialty panel responsible for reviewing the productstringmaxLength : 2
Product_CodeProduct Codestringrequired : 1 maxLength : 3
Device_NameDevice Category Namestringrequired : 1
Device_Classstringrequired : 1 enum : Array maxLength : 1
Unclassified_ReasonUnclassified Reason CodestringmaxLength : 2
Is_GMP_Exempt_FlagGMP Exempt Flagbooleanrequired : 1
Third_Party_FlagThird Party Review Eligiblestringrequired : 1 enum : Array maxLength : 1
Review_CodeThird Party Review Codestring-
Regulation_NumberRegulation number of classification regulation which identifies this devicestring-
Submission_Type_IDSubmission Type IDnumberlevel : Nominal
DefinitionDefinitionstring-
Physical_StatePhysical state of productstring-
Technical_MethodTechnical methodstring-
Target_AreaTarget area in bodystring-
Is_Implant_FlagImplant productboolean-
Is_Life_Sustain_Support_FlagLife Sustain productboolean-
Summary_Malfunction_ReportingIndicate if device is elegible for summary malfunction reporting or not.stringenum : Array
Review_PanelMedical_SpecialtyProduct_CodeDevice_NameDevice_ClassUnclassified_ReasonIs_GMP_Exempt_FlagThird_Party_FlagReview_CodeRegulation_NumberSubmission_Type_IDDefinitionPhysical_StateTechnical_MethodTarget_AreaIs_Implant_FlagIs_Life_Sustain_Support_FlagSummary_Malfunction_Reporting
SUMTJWax,BoneU1falseN1truefalseEligible
OPLXQCup, EyeU1falseN1falsefalseEligible
IMKEXSorter, CellU1falseN1falsefalseEligible
ORORHWJAwl1falseN888.45404falsefalseEligible
PMPMIPSCane1trueN890.30754falsefalseEligible
SUDZGSuture, Dental3falseN2truefalseEligible
DELYBLaser, DentalU1falseN1falsefalseEligible
HOLDIBlanket, FireU1falseN1falsefalseEligible
OPLXPPlug, ScleralU1falseN1falsefalseEligible
OPLZUPlug, PunctumU1falseN1falsefalseEligible