FDA Workshop Explores Potential Expansion of ASCA Program to Include Chemical Characterization
On November 6, 2024, the FDA held a workshop to discuss the potential expansion of the Accreditation Scheme for Conformity Assessment (ASCA) program to include chemical characterization per ISO 10993-18. This expansion would build upon the current ASCA program, which primarily covers select biological endpoint tests according to ISO 10993. Because the FDA has already reviewed and approved the test methods by accredited laboratories, the ASCA program is intended to reduce additional information (AI) requests and FDA reviewer time.
Morning Session
- Industry stakeholders spoke about extractables and leachables (E/L) testing approaches.
- Discussion focused on proficiency testing and the coverage map provided by surrogate compounds.
- FDA shared results from a recent round robin E/L study involving eight laboratories.
Afternoon Session
- Focused on the potential scope of an expanded ASCA program.
- Outlined proposed accreditation process for laboratories.
Proposed ASCA Accreditation Process
- External accreditation to ISO 10993-18, such as ISO 17025
- Submission of E/L testing protocols to FDA, including:
- Extraction procedures
- Equipment setup and verification
- Sample testing
- Data analysis
- Provision of personnel training evidence
If the FDA accredits a laboratory, reports can be summaries of procedures and results, with less FDA scrutiny. Challenging devices (e.g., hydrogels, degradables) that may require unique testing methods would fall outside of the ASCA accreditation program.
Key Discussion Points
The FDA sought input on various aspects of ISO 10993-18 testing, including:
- Test article preparation methods
- Use of response factor databases
- Selection of surrogate compounds for semi-quantitation
- Identification confidence criteria
Attendees, including Dr. Becky Bader and Dr. Stephen Spiegelberg from Cambridge Polymer Group, participated in the Q&A session and plan to provide additional written feedback.
Next Steps
The FDA will review workshop discussions and subsequent written feedback as they consider the potential expansion of the ASCA program. The agency will post responses to the questions raised during the workshop as they continue to evaluate this expansion.
This workshop represents another step in the ongoing dialogue between the FDA and industry stakeholders regarding chemical characterization testing for medical devices. The potential expansion of the ASCA program could have significant implications for both testing laboratories and device manufacturers.