CSDT Common Submission Dossier Template ˜ ˜˜˜ ˜ - FDA All Rights Reserved Health Sciences...

1 All Rights Reserved Health Sciences Authority

Dr Jiang Naxin Health Sciences Authority, Singapore

9 October 2012

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in vitro Diagnostic Medical Devices

CSDT Common Submission Dossier Template


Scope

§  Overview

§  Executive Summary

§  Other CSDT Sections

§  Submission Requirements

§  Q&A


DE001

DE002

DE003

Model 001 Model 002 Model 003 Model 004

DE003

C-12345

1 grouped product registration application

1 dossier

Single OR

Multiple SMDR listings

Multiple product models

DE001


ASEAN Common Submission Dossier Template (CSDT)

  Includes elements of the GHTF Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED)

  Intended as a harmonised format for pre-market

submission in ASEAN member economies

  Product Registration submissions to HSA must be prepared in the ASEAN CSDT format.


Main Sec�ons of the CSDT

  Executive Summary   Relevant Essential Principles and Method Used to

Demonstrate Conformity   Device Description   Summary of Design Verification and Validation

Documents   Device Labeling   Risk Analysis   Manufacturer Information


Scope

§  Overview




§  Q&A


Execu�ve Summary

  Overview   Commercial marketing history   Intended uses and indications   Regulatory approval or marketing clearance obtained   Status of pending regulatory approval   Important safety or performance information


  Regulatory Approval or Marketing Clearance obtained Ø Registration status in reference agencies

Execu�ve Summary

Reference agency

Intended use submitted for registration

Indications of use submitted for registration

Registration status (e.g. pending approval, rejected or withdrawn)

Reason of rejection or withdrawal

Australia - TGA

Canada – Health Canada

European Union – CE marked as Medical Device

Japan – MHLW

US - FDA


  Important Safety and Performance related Information Ø  Summary of adverse events and FSCAs

Execu�ve Summary

Description of adverse event

Frequency of occurrence (number of reports/total units sold)

Date of FSCA/ Recall Reason for FSCA / Recall

Countries where FSCA/ Recall was conducted

Year Product Name FSCA Description

Actions/comments Status

2009 XXXX Device Missing application software

Recall Close

2008 Software Application Card

Replacing old cards

Cards exchange Close


Relevant Essen�al Principles and Method Used to Demonstrate Conformity

  Essential Principles and Evidence of Conformity

Ø Essential Principles (EPs) of Safety and Performance comprises of:

-  General requirements of safety and performance that apply to ALL medical devices

-  Design and manufacturing requirements of safety and performance, relevant to specific medical device

No. Essen�al Principles – General Requirements

Applicable to the Device?

Method of Conformity

Iden�ty of Specific Documents

1 Medical Devices should be designed and manufactured in such a way that, when used under the condi�ons and for the purposes intended and, where applicable, by virtue of the technical knowledge, experience, educa�on or training of intended users, they will not compromise the clinical condi�on or the safety of pa�ents, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use cons�tute acceptable risks when weighed against the benefits to the pa�ent and are compa�ble with a high level of protec�on of health and safety.

Yes Quality System Standard:

-‐ ISO 13485: 2003

Risk Management Standard:

-‐ ISO 14971:2007

Design Control Procedures:

-‐S83782

Mfg A Ltd Corporate Quality Manual

ISO 13485 cer�ficate No. 135

Risk Management Report

Design Specifica�ons 322/2005/08


Scope

§  Overview




§  Q&A


Ø Manufacturer determines the applicable EPs and demonstrates conformity to each applicable EP

Ø Generally documented in a checklist format

Reference: GN-16 Guidance on Essential Principles for Safety

and Performance of Medical Devices. http://www.hsa.gov.sg/publish/hsaportal/en/health_products_regulation/medical_devices/regulatory_guidances.html

Relevant Essen�al Principles and Method Used to Demonstrate Conformity


Device Descrip�on   General description   Principles of operation   Risk class and applicable rule (GN-13, GN-14

Guidance)   Description of accessories or products which are

used in combination with the device   List of configurations or variants   Description of key functional elements, e.g. components, software, composition.   Labeled pictorial representation, if appropriate   Explanation of any novel features


List of Configura�ons

Present your devices/models/components/accessories clearly

Well Organized list of configurations = Correct SMDR listing

  Avoid Repetitions in models

  Organize components that are intended to be used together

  For IVDs, list the controls, calibrators and analyzers with the corresponding reagent kits for easy identification


Device Descrip�on

  Intended use   Indications   Instructions of use   Contraindications   Warnings   Precautions   Potential adverse effects   Alternative therapy

Instructions For Use

(IFU)

Sections not included in IFU must be addressed separately in the dossier


Pre-‐clinical studies -‐ IVD   Analytical Sensitivity   Analytical Specificity   Interfering Substances   Precision (Repeatability/ Reproducibility)   Linearity (Reportable Range)   Trueness   Recovery   Stability of reagent   Specimen type and storage recommendations   Potential Carryover

  Traceability & Expected Values (Controls, Calibrators, Methods)


Clinical studies -‐ IVD Performance evaluation studies using human specimens

  Clinical Sensitivity   Clinical Specificity   Performance evaluation studies in comparison to a

predicate/ well-established device   Clinical Cut-off   Reference Interval   For self-testing and point-of-care IVD, performance

evaluation when used by the target users e.g. lay person in case of self-testing IVD


  Copies (in original colour) of: Ø  Labels on the device and its packaging

ü For all levels of packaging ü Artwork ü If representative label provided for variants, variable fields on

artwork to be annotated

Ø Instructions for use (including operating manual and user manual)

Ø Patient information leaflet (where applicable)

Ø Promotional material (including brochures and catalogues)

Device Labelling


  To conduct risk analysis and risk management activities according to the ISO 14971: 2007 (recommended)

  Provide the risk management report containing details on risk analysis, risk evaluation, risk control and mitigation as conducted for the medical device

Risk Analysis


  Manufacturer

Ø  Identify sites for design and manufacturing activities – including OEM manufacturers

Ø Provide Quality Management System (QMS) certificates for design and manufacturing sites (including OEM) as an Annex to CSDT

Ø Manufacturing Process (flow chart)

Manufacturer Informa�on


  QMS Certificate – ISO 13485

Manufacturer Informa�on


Manufacturer Informa�on Manufacturing Process


Scope

§  Overview




§  Q&A


IVD -‐ Data Requirements CSDT Sec�on No.

Heading Abridged Submission Full Submission

Class B Class C Class D Class B Class C & D

3.0 Execu�ve Summary

Required 4.1.1 Essen�al Principles and

Evidence of Conformity

4.2 Device Descrip�on

4.4 Device Labelling

4.5.1 Risk analysis May be Required for certain medical devices

Required

4.6.1 Manufacturer Informa�on and Manufacturing Process Required




Class B

Class C

Class D

Class B

Class C & D

4.3.1 Pre-‐clinical studies   Analy�cal Sensi�vity and Specificity   Linearity and Reportable Range   Precision and Trueness   Stability of reagent   Specimen type and Storage   Biological material informa�on   Instruments/Analyzers -‐ Poten�al Carryover -‐ linearity, Precision -‐ So�ware Verifica�on & Valida�on   Traceability & Expected Values (Controls, Calibrators, Methods)

Summary Detailed informa�on

4.3.1




Class B

Class C

Class D Class B

Class C & D

4.3.2 Clinical evidence

§  Diagnos�c Sensi�vity and Specificity

§  Comparison Studies using Clinical Specimens to performance of predicate device

§  Comparing device performance to accepted diagnos�c procedures


§  Performance evalua�on studies for the normal condi�ons of use -‐ for self-‐tes�ng and near pa�ent tes�ng



Organiza�on of the Dossier Contents


Organiza�on of the Dossier Certificates/Reports/Supporting Documents


Scope

§  Overview




§  Q&A


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Thank You!

CSDT Common Submission Dossier Template ˜ ˜˜˜ ˜ - FDA All Rights Reserved Health Sciences...

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Transcript of CSDT Common Submission Dossier Template ˜ ˜˜˜ ˜ - FDA All Rights Reserved Health Sciences...