- About FDA
- Medical devices, IVDs, drugs, combination products and CDx: FDA divisions and offices
- FDA Centre for Devices and Radiological Health (CDRH)
- Code of Federal Regulations (CFR)
- Standards and other guidance documents
Harmony & Discord
- A comparison of US and European Medical Device Regulatory Affairs
- Regulatory commonalities, overlaps and discprepancies
- Future trends
An introduction to routes to the US Market
- Classification
- Premarket Notification – (510(k)
- Introduction to Traditional, Abbreviated, Special, de novo & Exemptions
- Predicates & substantial equivalence
- Premarket approval (PMA)
- Modules, modular and full submissions
- Role of QMS (CFR Part 820)
- Quality Assurance
- Quality Control
- What is the impact of IVDR on the ability to enroll patients into trials?
- How is IVDR impacting trials that have patient selection and further what is the impact to inclusion/exclusion and assays/data used for medical management?
- How is country by country variability impacting trials and how divergent are the various opinions?
- What is the expected impact of the US LDT regulations and what is different/the same to IVDR?
- What infrastructure is needed to support these changes for drug developers, sites and laboratories?
- Have laboratories managed to meet the requirements of IVDR and what are the current gaps?
- What infrastructure does the industry need to build for a better future state?
- Conformity assessments for Class D
- Current requirements from Notified Bodies
- Challenges for manufacturers
- A focus on current common specifications
- What changed within the new version?
- How much effect does this change have on industry?
- How are notified bodies ensuring compliance to these specifications?
What is the practical impact of IVDR for health institutions, both when new CE-IVD kits come onto the market and when CE-IVD kits are (temporarily) taken off the market? Where can health institutions collaborate with industry to increase patient safety?
- Current requirements for adverse events, FSCAs and trend reporting
- Similarities and differences across regions
- UK Case study: filing an adverse event on new MORE Web Portal
- Differences between UK & Northern Ireland
Meeting regulatory expectations in biocompatibility testing for medical devices
Biocompatibility challenges during MDR certification of legacy devices.
Addressing the “gap’ between regulatory expectations and industry practices
- Under which regulations can RWE be used?
- Is RWE enough on it’s own or does a clinical trial always need to be carried out?
- Can it be used for both devices and diagnostics?
- Case studies: suitable RWE for differing risk classes
- Examples of collection, analysis and use in technical documentation
- With reference to MDCG 2022-14, is leveraging data a falsehood?
- When can data be leveraged or when is new data collection necessary?
- Which data could be leveraged?
- Could it be leveraged for devices of all classes?
- Case study: unsuccessful use of previous data and lessons learnt
- Tips for future leveraging attempts
With the recent updates and newly revised ISO 10993-1, join us in discussion as we navigate the anticipated effects of these regulatory changes.
- Eudamed Clinical Module: overview and status / transparency
- Clinical investigations and PMCF applications: key insights and harmonized approach?
- Diversity of clinical data collection?
- Which improvements from MDCG 2022-14 would be of values to the MDR transition?
- Potential Shortages of Commercially Available tests and an expected reduction in labs able to use IH-IVDs (LDTs for routine testing purposes with Precision Medicines
- Potential delays in clinical trials of Precision Medicines using IVDs with a medical purpose.
- Notification [510(k)] vs Approval (PMA) output data requirements
- Preclinical data: design verification
- Clinical data: design validation
- The importance of project management: saving time and cost to market
- Design change: pre-planned and/or response to market feedback
- Imposing Quality throughout the product lifecycle to save time and cost
- Role in Product Development, Design Control and Design Review
- Input to Risk Management
- Importance for manufacturing
- Quality Control
- Audits and Inspections
- Forthcoming regulatory changes
- Overview of Direct vs. Indirect Clinical Benefits and the challenges
- Defining Safety and Performance Outcomes and Acceptance Criteria for Indirect Clinical Benefits
- Leveraging Safety and Performance Standards vs. Clinical Literature
- How diverse is clinical and performance data which is currently being collected?
- Is diversity covered in regulation?
- How much obligation is there for collecting diverse data?
- Availability and usability of diverse data
- Importance of enhancing diversity moving forward
Please contact: Roshni Shah roshni.shah@informa.com
Or Call +44 (0)7776636553 if you are interested in participating as a speaker, panellist, moderator or hosting a webinar
- Determining data sufficiency under the MDR & IVDR
- Are clinical or performance studies always necessary?
- When can you leverage previous data?
- Best practices for ensuring sufficient data
- Proper study design and thorough planning that considers device-specific intricacies in sample preparation is crucial for a successful biological evaluation. Improper sample preparation or extraction conditions can lead to additional evaluation time, testing costs, and animal use.
In this session, we will discuss some of the main contributing factors associated with:
Improper test article preparation.
Improper extraction conditions.
- Determining what is and when to use research-initiated studies
- Influence of medical staff in initiating studies
- Benefits of such studies
- Best practices in fostering working relationships with hospitals
- Future impact
- How can utilising research-initiated studies benefit industry and the wider population?
- What is Q-sub (still commonly known as a ‘pre-sub) and how does it benefit both the manufacturer and FDA
- How to prepare a ‘pre-sub’ document
- The ‘pre-sub’ meeting
- FDA feedback & follow up with the Agency
- Next steps
The revised draft of the new Part 1 has brought about multiple changes so join us as we discuss its effects on the biological evaluation process.
- Current regulations for performance evaluations under the IVDR
- Latest updates & on-going work
- Differences across regions
- Key documentation, data points and responsibilities for industry
Have burning questions left over from the last 2 days? Take the opportunity to connect with our speakers and raise those final questions in our ‘Ask the Experts’ panel!
Please contact: Roshni Shah – roshni.shah@informa.com
Or Call +44 (0)7776636553 if you are interested in participating as a speaker, panellist, moderator or hosting a webinar
- Classification: routes to market
- Comparison with EU/UK
- The 513(g) procedure
- Revieing New Approach Methodologies (NAM)
- Identifying the various types of sensitizers that leach from medical devices
- Data initiatives tox reports and literature
• Overview of biological risk assessment per ISO 10993-1:2018
• What’s on the horizon for biological risk assessment per revisions that are currently under discussion
• Illustration of biological safety evaluation using a true risk assessment approach through a case study
- Current regulations for clinical evaluations and investigations for devices
- How do they differ between the UK, Switzerland and the US?
- Focal points
- Which areas are under review or in the pipeline?
- Working plan for agencies
- Dissecting and explaining the requirements of MDR GSPR 10.4
Examples of hazardous substances
Determination whether hazardous substances are present above 0.1% w/w
To Do’s when hazardous substances are present above 0.1% w/w
- The 510(k) process, different types of 510(k) and De Novo submissions
- Predicate Devices
- Contents of a 510(k) submission
- Decision Summaries
- Post-market considerations including modifications to cleared devices (post-market requirements): keeping product on the US market
- The PMA process and different types of PMAs
- Contents of a PMA submission
- Summary of Safety and Effectiveness Data (SSED)
- PMA Annual Reporting
- Modifications to approved devices
- Production and process controls
- Inspection of measuring and test equipment
- Process validation
- Feedback on the status of the reference labs
- How are Notified Bodies working without them?
- How many are expected to be designated and by when?
- Impact on Notified Bodies and manufacturers once designated
- Working example: IVD approval with EURL involvement
- Current regulations for clinical evaluations and investigations for devices
- How do they differ between the UK, Switzerland and the US?
- Focal points
- Which areas are under review or in the pipeline?
- Working plan for agencies
- Current regulations for performance evaluations under the IVDR
- Latest updates & on-going work
- Differences across regions
- Key documentation, data points and responsibilities for industry
- Eudamed Clinical Module: overview and status / transparency
- Clinical investigations and PMCF applications: key insights and harmonized approach?
- Diversity of clinical data collection?
- Which improvements from MDCG 2022-14 would be of values to the MDR transition?
- Determining data sufficiency under the MDR & IVDR
- Are clinical or performance studies always necessary?
- When can you leverage previous data?
- Best practices for ensuring sufficient data
- Overview of Direct vs. Indirect Clinical Benefits and the challenges
- Defining Safety and Performance Outcomes and Acceptance Criteria for Indirect Clinical Benefits
- Leveraging Safety and Performance Standards vs. Clinical Literature
- Under which regulations can RWE be used?
- Is RWE enough on it’s own or does a clinical trial always need to be carried out?
- Can it be used for both devices and diagnostics?
- Case studies: suitable RWE for differing risk classes
- Examples of collection, analysis and use in technical documentation
Please contact: Roshni Shah – roshni.shah@informa.com
Or Call +44 (0)7776636553 if you are interested in participating as a speaker, panellist, moderator or hosting a webinar
- Determining what is and when to use research-initiated studies
- Influence of medical staff in initiating studies
- Benefits of such studies
- Best practices in fostering working relationships with hospitals
- Future impact
- How can utilising research-initiated studies benefit industry and the wider population?
- How diverse is clinical and performance data which is currently being collected?
- Is diversity covered in regulation?
- How much obligation is there for collecting diverse data?
- Availability and usability of diverse data
- Importance of enhancing diversity moving forward
The revised draft of the new Part 1 has brought about multiple changes so join us as we discuss its effects on the biological evaluation process.
• Overview of biological risk assessment per ISO 10993-1:2018
• What’s on the horizon for biological risk assessment per revisions that are currently under discussion
• Illustration of biological safety evaluation using a true risk assessment approach through a case study
- Proper study design and thorough planning that considers device-specific intricacies in sample preparation is crucial for a successful biological evaluation. Improper sample preparation or extraction conditions can lead to additional evaluation time, testing costs, and animal use.
In this session, we will discuss some of the main contributing factors associated with:
Improper test article preparation.
Improper extraction conditions.
With the recent updates and newly revised ISO 10993-1, join us in discussion as we navigate the anticipated effects of these regulatory changes.
- Revieing New Approach Methodologies (NAM)
- Identifying the various types of sensitizers that leach from medical devices
- Data initiatives tox reports and literature
- Dissecting and explaining the requirements of MDR GSPR 10.4
Examples of hazardous substances
Determination whether hazardous substances are present above 0.1% w/w
To Do’s when hazardous substances are present above 0.1% w/w
Meeting regulatory expectations in biocompatibility testing for medical devices
Biocompatibility challenges during MDR certification of legacy devices.
Addressing the “gap’ between regulatory expectations and industry practices
- Conformity assessments for Class D
- Current requirements from Notified Bodies
- Challenges for manufacturers
- A focus on current common specifications
- What changed within the new version?
- How much effect does this change have on industry?
- How are notified bodies ensuring compliance to these specifications?
- Feedback on the status of the reference labs
- How are Notified Bodies working without them?
- How many are expected to be designated and by when?
- Impact on Notified Bodies and manufacturers once designated
- Working example: IVD approval with EURL involvement
- With reference to MDCG 2022-14, is leveraging data a falsehood?
- When can data be leveraged or when is new data collection necessary?
- Which data could be leveraged?
- Could it be leveraged for devices of all classes?
- Case study: unsuccessful use of previous data and lessons learnt
- Tips for future leveraging attempts
What is the practical impact of IVDR for health institutions, both when new CE-IVD kits come onto the market and when CE-IVD kits are (temporarily) taken off the market? Where can health institutions collaborate with industry to increase patient safety?
Please contact: Roshni Shah roshni.shah@informa.com
Or Call +44 (0)7776636553 if you are interested in participating as a speaker, panellist, moderator or hosting a webinar
- Potential Shortages of Commercially Available tests and an expected reduction in labs able to use IH-IVDs (LDTs for routine testing purposes with Precision Medicines
- Potential delays in clinical trials of Precision Medicines using IVDs with a medical purpose.
- What is the impact of IVDR on the ability to enroll patients into trials?
- How is IVDR impacting trials that have patient selection and further what is the impact to inclusion/exclusion and assays/data used for medical management?
- How is country by country variability impacting trials and how divergent are the various opinions?
- What is the expected impact of the US LDT regulations and what is different/the same to IVDR?
- What infrastructure is needed to support these changes for drug developers, sites and laboratories?
- Have laboratories managed to meet the requirements of IVDR and what are the current gaps?
- What infrastructure does the industry need to build for a better future state?
- Current requirements for adverse events, FSCAs and trend reporting
- Similarities and differences across regions
- UK Case study: filing an adverse event on new MORE Web Portal
- Differences between UK & Northern Ireland
Have burning questions left over from the last 2 days? Take the opportunity to connect with our speakers and raise those final questions in our ‘Ask the Experts’ panel!
- About FDA
- Medical devices, IVDs, drugs, combination products and CDx: FDA divisions and offices
- FDA Centre for Devices and Radiological Health (CDRH)
- Code of Federal Regulations (CFR)
- Standards and other guidance documents
Harmony & Discord
- A comparison of US and European Medical Device Regulatory Affairs
- Regulatory commonalities, overlaps and discprepancies
- Future trends
An introduction to routes to the US Market
- Classification
- Premarket Notification – (510(k)
- Introduction to Traditional, Abbreviated, Special, de novo & Exemptions
- Predicates & substantial equivalence
- Premarket approval (PMA)
- Modules, modular and full submissions
- Role of QMS (CFR Part 820)
- Quality Assurance
- Quality Control
- Classification: routes to market
- Comparison with EU/UK
- The 513(g) procedure
- What is Q-sub (still commonly known as a ‘pre-sub) and how does it benefit both the manufacturer and FDA
- How to prepare a ‘pre-sub’ document
- The ‘pre-sub’ meeting
- FDA feedback & follow up with the Agency
- Next steps
- The 510(k) process, different types of 510(k) and De Novo submissions
- Predicate Devices
- Contents of a 510(k) submission
- Decision Summaries
- Post-market considerations including modifications to cleared devices (post-market requirements): keeping product on the US market
- The PMA process and different types of PMAs
- Contents of a PMA submission
- Summary of Safety and Effectiveness Data (SSED)
- PMA Annual Reporting
- Modifications to approved devices
- Notification [510(k)] vs Approval (PMA) output data requirements
- Preclinical data: design verification
- Clinical data: design validation
- The importance of project management: saving time and cost to market
- Design change: pre-planned and/or response to market feedback
- Imposing Quality throughout the product lifecycle to save time and cost
- Role in Product Development, Design Control and Design Review
- Input to Risk Management
- Importance for manufacturing
- Quality Control
- Audits and Inspections
- Forthcoming regulatory changes
- Production and process controls
- Inspection of measuring and test equipment
- Process validation