Formación a Medida - Preparación de Expedientes de Registro según Modelo 510K de la FDA


Estos programas pueden adaptarse en contenidos y horarios de acuerdo a sus necesidades. Consúltenos una solución formativa a medida en:

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Programa

1 Basic Regulatory requirements in the U.S.

  • 1.1 Establishment registration
  • 1.2 Premarket notification 510K
  • 1.3 Premarket approval (PMA)
  • 1.4 Investigational device exemption (IDE) for Clinical Studies
  • 1.5 Quality System (QS) Regulation
  • 1.6 Labeling Requeriments
  • 1.7 Medical Device Reporting (MDR)

 

2 Premarket notification

  • 2.1 Introduction
  • 2.2 What is substancial equivalence
  • 2.3 Who is required to submit a 510(K)
  • 2.4 When a 510(K) is required
  • 2.5 When a 510(K) is not required
  • 2.6 Third party review program

 

510K Submission process

  • 3.1 Introduction
  • 3.2 Log-in procedures
  • 3.3 Division acceptance and review
  • 3.4 FDA requests for additional information
  • 3.5 510K status program

 

Content of a 510K

  • 4.1 Introduction
  • 4.2 General information
  • 4.3 Table of contents
  • 4.4 510K screening checklist (recommended)
  • 4.5 Statement of indication for use
  • 4.6 510K summary or statement
  • 4.7 Truthful and accurate statement
  • 4.8 Proposed labeling
  • 4.9 Specifications
  • 4.10 Substantial equivalence comparison
  • 4.11 Performance
  • 4.12 Additional requirements

 

How to prepare a traditional 510K

  • 5.1 Introduction
  • 5.2 Find a predicate device
  • 5.3 Local Guidance Documents
  • 5.4 Content and format of a traditional 510K
  • 5.5 Alternate 510K format - STED pilot program
  • 5.6 Where to submit a 510K

 

Classify your medical devices

  • 6.1 How to determine classification
  • 6.2 What are the classification panels

          • 6.2.1 How to locate classification regulations

          • 6.2.2 Market submission options

              - 6.2.2.1 510K

              - 6.2.2.2 Exempt

              - 6.2.2.3 PMA

 

Premarket approval (PMA)

  • 7.1 Overview
  • 7.2 When a PMA is required
  • 7.3 Devices used in blood establishments
  • 7.4 Data requirements

 

Class I/II Exemptions

  • 8.1 Introduction
  • 8.2 Devices exempt from 510K

 




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