SVP Clinical Operations
The Beaufort team was a proud sponsor of The Association of Medical Device Manufacturers (AMDM) Fall IVD Focus Meeting held last week (Oct 19-20) in Los Gatos, CA.
Here are several highlights from the 2023 meeting:
FDA Update On LDT Proposed Rule Changes
On September 29, 20203, the FDA released a Proposed Rule for assuring the Safety & Efficacy of Laboratory Developed Tests (LDTs). This proposal will represent a dramatic shift and phaseout of FDA’s general enforcement discretion approach to LDTs. The AMDM presentation provided an overview of the guidance included the following discussion items:
- Proposed Rule brings LDTs under full FDA regulation and generally fall under the same enforcement approach as other IVDs.
- FDA’s rationale for the Proposed Rule:
- There is no sound basis for regulating LDTs and other IVD tests differently.
- LDT results may not be reliable for patient management use.
- Some LDTs show poor reproducibility of results, lack validation, no clinical data to support use and poor overall performance.
- Evolution and proliferation of LDTs
- Supports increased safety and protection of public health.
- FDA’s rationale for the Proposed Rule:
- FDA was not able to share a timeline but the expected close-out timeline for comments is December 2023.
- Final Rule projected to be published by Spring 2024.
Last week, FDA announced a webinar to be held on Tuesday, October 31st to review the guidance as outlined above as well as answer questions. You can register here:
Software Submission Best Practices
2023 FDA Software Guidance includes a more rigorous look at risk classifications: Risk to the user and patient. For IVDs, software is reviewed as a test system. Tables below, presented by Karen Bijwaard, MS, RAC, MB(ASCP), CQA (CDRH/OPEQ/OHT7/DMGP), show the differences between the 2005 FDA Guidance and the 2023 FDA Guidance language.
| Software documentation element | Level of Concern (2005 guidance) | Documentation Level (2023 guidance) | ||
|---|---|---|---|---|
| Moderate | Major | Basic | Enhanced | |
| System and software architecture design | Detailed depiction of functional units and SW modules. May include state diagrams as well as flow charts. | Detailed diagrams of the modules, layers, and interfaces that comprise the device, their relationships, the data inputs/outputs and flow of data, and how users or external products (including information technology (IT) infrastructure and peripherals) interact with the system and SW. | ||
| Traceability | Traceability among requirements, specifications, identified hazards and mitigations, and Verification and Validation testing. | Provided within required documentation. | ||
| Software development, configuration management, and maintenance practices | Summary of SW life cycle development plan, including a summary of the configuration management and maintenance activities. | Summary of SW life cycle development plan. Annotated list of control documents generated during development process. Include the configuration management and maintenance plan documents. | A summary of the life cycle development plan and a summary of configuration management and maintenance activities; OR A Declaration of Conformity to the FDA-recognized version of IEC 62304, including subclauses 5.1.1-5.1.3, 5.1.6 – 5.1.9, clause 6 (Software maintenance process), and clause 8 (SW configuration management process), among others as applicable. | Basic Documentation Level, PLUS complete configuration management and maintenance plan document(s); OR A Declaration of Conformity to the FDA-recognized version of IEC 62304, including subclause 5.1 (Software development planning), clause 6 (software maintenance process), and clause 8 (software configuration management process), among others as applicable. |
| Software documentation element | Level of Concern (2005 guidance) | Documentation Level (2023 guidance) | ||
|---|---|---|---|---|
| Moderate | Major | Basic | Enhanced | |
| Documentation level evaluation | A statement indicating the Level of Concern and a description of the rationale for that level. | A statement indicating the Documentation Level and a description of the rationale for that level. | ||
| Software description | A summary overview of the features and SW operating environment. | SW description, including overview of significant SW features, functions, analyses, inputs/outputs, and hardware platforms. | ||
| Risk management file | Tabular description of identified hardware and SW hazards, including severity assessment and mitigations. | Risk management plan, risk assessment demonstrating that risks have been appropriately mitigated, and risk management report. | ||
| Software requirements specification (SRS) | Complete SRS document. Describes functional, performance, interface, design, developmental, and other requirements for the SW (e.g., hardware requirements, programing language, identification of off-the-shelf SW, etc.). | SRS documentation, describing the needs or expectations for a system or SW, presented in an organized format, at the SW system level or subsystem level, as appropriate, and with sufficient information to understand the traceability of the information with respect to the other SW documentation elements (e.g., risk management file, SW design specification, system and SW architecture design chart, SW testing). | ||
| Software design specification (SDS) | SW design specification document describes the implementation of the requirements for the SW Device. Should provide adequate information to allow for review of the implementation plan for the SW requirements in terms of intended use, functionality, safety, and effectiveness. | SW design specification document describes the implementation of the requirements for the SW Device. Should provide adequate information to allow for review of the implementation plan for the SW requirements in terms of intended use, functionality, safety, and effectiveness. | FDA is not recommending the SDS as part of the premarket submission. Sponsor should document this information on the design via the DHF for the device. During premarket review, FDA may request additional information, if needed, to evaluate the safety and effectiveness of the device. | SDS documentation, including sufficient information that would allow FDA to understand the technical design details of how the software functions, how the software design completely and correctly implements all the requirements of the SRS, and how the software design traces to the SRS in terms of intended use, functionality, safety, and effectiveness. |
New FDA Voluntary Pilot Program for Oncology Drug Products
FDA announced a voluntary pilot program for Industry with the objective of obtaining/providing greater transparency of minimum performance characteristics that certain tests for certain oncology drugs should meet. This pilot program will not alter the standards for the approval of oncologic drug products or for the marketing authorization of the corresponding companion in vitro diagnostics. FDA Guidance Document was published on 20 Jun 2023.
Additional Meeting Takeaways
- FDA is trying to return to “Normal”
- Reauthorization of Medical Device User Fee Amendments (MDUFA)
- Hundreds of COVID tests under EUA – continue to encourage manufacturers to seek traditional market clearance.
- Review of all submission types has resumed.
- “564” still active – no termination yet.
- Center Initiative Highlights:
- CDRH’s Customer Collaboration Portal: dashboard displays real-time submission status; FDA has received over 21,000 submissions, over 80% of submission come through portal, over 9,000 users.
- eStar: As of October 1, 2023, all 510(k) submissions, unless exempted, must be submitted electronically using eSTAR
- Predetermined Change Control Plans: working on change control protocols – AST is an area where the Agency cleared many protocols.
- Breakthrough Devices Program: >169 designated IVD devices; 18 IVD Devices authorized to market, 6 PMAs approved, 4 510(k)s cleared, 8 De Novos granted.
Contact us today to discuss how any of these issues impact your business – and see how we can help you bring your IVD product successfully through the changing regulatory landscape.