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Presentation: Medical Devices: how to stay included workshop - Post-market reviews
The document outlines the post-market review process for medical devices managed by the TGA, emphasizing the need for strong collaboration between manufacturers and sponsors, as well as the importance of proper documentation for compliance. It provides insights into monitoring, risk assessment, and the types of evidence required during reviews, including case studies on heart valves and tissue morcellators. Additionally, it highlights key messages for manufacturers on submission requirements and encourages adherence to established guidelines.
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Presentation: Medical Devices: how to stay included workshop - Post-market reviews
- 1. Medical Devices: howto stay included Post-market reviews Amanda Craig Technical Officer Device Vigilance and Monitoring Section Medical Devices Branch Therapeutic Goods Administration
- 2. Learning outcomes It isenvisaged at the end of this session you will you be able to: • understand the post-market review process of medical devices. • appreciate the importance of strong working relationship between the manufacturer and sponsor. • recognise appropriate and acceptable documentation that provides evidence of compliance with the Essential Principles. • understand the continuum of a QMS, with the evidence informing the CER, which informs the risk assessment, which in turn informs the risk mitigation strategies, for the life of the device. • implement processes to ensure appropriate responses to post-market vigilance and post- market reviews. Medical Devices: how to stay included 1
- 3. Overview • The TGA’srole in post-market monitoring • Post-market monitoring the why, who, when, and what • Quality Management System Clinical evaluation report Literature search Risk management documentation Instructions for Use Technical documentation Medical Devices: how to stay included 2
- 4. Role of theTGA in post-market monitoring The TGA’s role is to continually monitor and evaluate the safety and efficacy or performance of therapeutic goods that are available on the market and to manage any risks associated with individual products. Number of reviews Year # ARTG entries # completed 2014 226 168 2015 195 116 …2016 (As at 24 May 2016) 186 28 We regulate therapeutic goods throughout their lifecycle in a number of ways Assess evidence Register Enforce compliance Monitor Changes to product information, safety alerts, recalls 3
- 5. Post-market monitoring • Whyare post-market reviews conducted (not an exhaustive list): − Trends from IRIS − Recurrent advertising breaches − Unresolved/repeated recalls − Information from other regulatory agencies − ARTG anomalies • Who or what is reviewed: − Sponsor − Manufacturer − Ingredient − Product − Kind of device • When: − Any point in the product’s life-cycle. Medical Devices: how to stay included 4
- 6. Case study #1– heart valve Signal: • adverse events relating to leaflet breakage IRIS investigation • same problem reported from another manufacturer’s heart valve TGA checks available data reports for other heart valves recall for heart valve Review of all similar heart valves to determine if isolated issue or systemic Medical Devices: how to stay included 5
- 7. Post-market review process Callingin and reviewing: - Essential Principles checklist - Post-market data incl. supply, adverse events and complaints - Labels - IFU - Current clinical evidence report - Risk management documentation - Declaration of conformity & manufacturer’s certification - Technical documentation - Ingredients and formulations of medicated/formulated devices - Advertising material - CAPAs - Samples Dependent on the issue under review Medical Devices: how to stay included 6
- 8. Case study #1– heart valve • Information requested – Clinical evidence – Technical documentation – Risk assessment documents – IFUs – Post-market data Medical Devices: how to stay included 7
- 9. Post-market review: evidence Whatto submit: - Cover letter explaining documents (Table of Contents) - All information requested in a single submission on time - Information in a clear and logical format - Linked information - Accurate data - Referenced documents - Documents in English - Electronic submission Clinical Evidence Report Risk assessment Risk mitigations Post-market vigilance Medical Devices: how to stay included 8
- 10. Post-market review: evidence WhatNOT to submit: - Multiple unlinked or unclear emails - Separate documents over several days - Incomplete dossier - Excerpts from documents - Data dump - Documents with data integrity issues Clinical Evidence Report Risk assessment Risk mitigations Post-market vigilance Medical Devices: how to stay included 9
- 11. Evidence: Clinical evaluationreport Flow-through Risk assessment documentation Risk mitigation strategies Data Evaluation Critical analysis and synthesis of data Risk and benefit conclusion Data Acquisition Literature search Clinical trial data Post-market surveillance Authored/approved by an expert in the field, accompanied by their CV as evidence of that. Medical Devices: how to stay included 10
- 12. Evidence: Literature search •Must be unbiased and reproducible – Period covered by search – Databases used – Search terms – Filters/criteria of inclusion – Exclusion criteria • Number of citations from each database • List of excluded citations with justification • Full copy of all publications included, in English • Published, peer-reviewed literature, i.e. not newspaper or magazine article Potential literature • From identified search terms and inclusion criteria Publications reviewed • Literature excluded with reasons (list provided) Relevant literature • Literature excluded from clinical evaluation with reasons http://www.tga.gov.au/systematic-literature-searches-literature-based-submissions 11
- 13. Evidence: Risk management Pre-market development Post-marketvigilance Hazard identification Adverse event reporting Complaint management Hazard recognition Sentinel event recognition Risk evaluation Health hazard evaluation Risk control application Corrective and Preventative Action (CAPA) Risk control verification/validation CAPA Identification Assessment Mitigation Frequency Severity ISO 14971 Medical Devices: how to stay included 12
- 14. Evidence: Instructions foruse – Manufacturer is responsible for packaging, labelling, instructions for use, and training – Appropriate for product – Risk mitigation Not 1st line of risk mitigation – Essential Principle 13 – Essential Principle Checklist – 10.2 – Information about the Sponsor Therapeutic Goods (Medical Devices) Regulations 2002 Medical Devices: how to stay included 13
- 15. Evidence: Technical documentation Validationof evidence for relevant EPs, dependent upon scope/issue being reviewed. For example: • EP checklist • Conformity report against relevant technical standards • ISO 13485 certification for manufacturer • Test reports demonstrating design and development changes; verification and validation • Verification of purchased products • Sterilisation process records • Useability studies Technical standards Conformity Report Risk assessment – design & manufacturing Risk mitigation – validation & verification of QMSMedical Devices: how to stay included 14
- 16. Case study #1– heart valve • Information requested – Clinical evidence – Technical documentation – Risk assessment documents – IFUs – Post-market data • What was sent – Multiple emails with lots of journal articles – IFUs – EP checklist – Risk assessment • When was it sent – Following a reminder s41JA letter – Emails stretched across a week or more So, what happened next? Medical Devices: how to stay included 15
- 17. Post-market review outcomes •Closure of review • Not in scope • Sufficient and satisfactory evidence provided • Amendment to Instructions for Use • With or without recall action • Recall of devices or safety notice • Additional conditions of inclusion (s41 FP) • Suspension (s41 GA & GF) • Cancellation (s41 GK, GL, GM, & GN) • Referral to: • Advertising Compliance (s42 DL), or • Regulatory Compliance Uniform Recall Procedure for Therapeutic Goods (www.tga.gov.au/industry/recalls- urptg) Medical Devices: how to stay included 16
- 18. What happened next? Casestudy #1 – heart valve • Proposal to Cancel (s41GN(2)) – Failure to provide information after a s41JA letter (s41GN(1)(c)); and – Failure to comply with the Conditions of Inclusion (s41GN(1)(b)) sufficient information is provided that shows compliance with the Essential Principles; and – The safety and performance of the device is unacceptable (s41GN(1)(d)) Medical Devices: how to stay included 17
- 19. What happened next? Casestudy #1 – heart valve • Sponsor provided response within 20 workings days – did not include the required information – assessment of the material supplied still did not alleviate TGA’s concern about the safety and performance of the device • A letter cancelling the device based on the previous three provisions • Cancellation was published on TGA’s website Medical Devices: how to stay included 18
- 20. Post-market review statistics Year#ARTG entries #completed Cancelled by Sponsor Cancelled by TGA 2014 226 168 34 13 2015 195 116 18 10 …2016 (as at 24 May 2016) 186 21 9 0 TGA cancellations Reason # 2014 # 2015 #2016… Not replying to a s41JA request for information 6 0 0 Non compliance with automatic conditions of inclusion 7 10 0 Medical Devices: how to stay included 19
- 21. Reasons for Sponsorcancellations Reason # 2014 # 2015 # 2016 (as at 24 May) Change of sponsor 5 1 0 Change in manufacturer 1 0 0 No device supplied under entry 5 2 1 Device no longer supplied 6 10 1 Information not provided 11 3 1 Incorrectly classified 1 0 6 Model superseded 2 1 0 No longer the distributor 3 0 0 No longer making medical claims 0 1 0 Medical Devices: how to stay included 20
- 22. Key messages • Post-marketreviews – Read the request for information carefully – Provide considered answers to the questions, making links between the information provided and the issue being explored – Ensure documentation is current, relevant, and appropriately labelled – It is not the responsibility of the TGA to decipher the dossier; it is the manufacturer's responsibility to put two and two together – If the submission is complex or contains multiple documents, add a flow chart, table of contents, and/or narrative to guide the reviewer – If a document is referred to in your submission it should also be supplied – If in doubt, contact the TGA Medical Devices: how to stay included 21
- 23. Case Study #2– tissue morcellators Signal: • Information from FDA TGA checks available data clinical report request feedback from Sponsors Review of all tissue morcellators on the ARTG Medical Devices: how to stay included 22
- 24. Case study #2– tissue morcellators • Information requested – IFUs – Post-market data • What was sent – IFUs – Supply and adverse event data • When was it sent – Within the specified timeframe by all Sponsors So, what happened next? Medical Devices: how to stay included 23
- 25. What happened next? Casestudy #2 – tissue morcellators • Amended IFUs distributed through recall sections with new black box warning Medical Devices: how to stay included 24
- 26. Learning outcomes At theend of this session it is envisaged that you will: • Have an understanding of the post-market review process of medical devices. • Appreciate the importance of strong working relationship between the manufacturer and sponsor. • Recognise appropriate and acceptable documentation that provides evidence of compliance with the Essential Principles. • Understand the continuum of a QMS, with the evidence informing the CER, which informs the risk assessment, which in turn informs the risk mitigation strategies, for the life of the device. • Implement processes to ensure appropriate responses to post-market vigilance and post- market reviews. Medical Devices: how to stay included 25
- 27. Further information • TherapeuticGoods Act 1989 • Therapeutic Goods (Medical Devices) Regulations 2002 – http://www.tga.gov.au/legislation-legislative-instruments • Australian regulatory guidelines for medical devices – http://www.tga.gov.au/publication/australian-regulatory-guidelines-medical-devices-argmd • Essential Principles checklist – http://www.tga.gov.au/form/essential-principles-checklist-medical-devices • Systematic literature searches for literature based submissions – http://www.tga.gov.au/systematic-literature-searches-literature-based-submissions • Draft clinical evidence guidelines – Medical devices – https://www.tga.gov.au/consultation/consultation-draft-clinical-evidence-guidelines-medical-devices • International Medical Device Regulators Forum – www.imdrf.org Medical Devices: how to stay included 26