A 2020 FDA guidance may soon help boost consistency in medical device testing and expedite review of submissions for eligible devices.
At MD&M BIOMEDigital, Chris Parker, head of in-vivo biocompatibility at Toxikon, explained that in Sept. 2020, FDA published final guidance on Accreditation Scheme for Conformity Assessment (ASCA), launching a program where labs that perform testing for ISO 10993—Biocompatibility and IEC 61010/IEC 60601–Basic Safety and Essential Performance can become accredited by the FDA.
The key ASCA takeaway for manufacturers is that the testing performed to recognized standards at these accredited labs may be submitted with only a summary report instead of a full report (if no unexpected results occur) and they can expect an expedited review during submission.
Parker explained that this effort began as a pilot program, advancing to FDA guidance documents in Sept. 2020:
- Program guidance: The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program - Final Guidance
- Basic Safety and Essential Performance standards-specific guidance: Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program
- Biocompatibility standards-specific guidance: Biocompatibility Testing of Medical Devices- Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program
In early 2021, the first wave of accredited bodies (ABs) was published, and it is projected that in Apr. 2021, the first wave of FDA-approved labs will be posted. This depends on timelines for ABs as they can become quite busy.
Participation is voluntary, and it revolves not just around the technical standards, but quality systems as well.
The FDA website will show (1) which labs are accredited and (2) what they’re accredited for as a lab could accredited for multiple methods, or just cytotoxicity for example.
- The FDA will audit both ABs and test labs as necessary.
- When a manufacturer performs testing at an accredited test lab, the lab will provide a standard report as well as a summary report.
- Provided testing takes place without unexpected results, the manufacturer can submit to FDA with a Declaration of Conformity (DOC) and summary report for pre-market submission review.
It’s important to note that all devices are eligible except for liquids, creams, gels, hydrogel devices, devices containing nanomaterials, and absorbable and in situ polymerizing devices. “Things that are going to break down, or have an active integration that could polymerize such as a skin glue, because these are more of a dynamic process… the ISO standards are written more for an extraction type of environment and these may have some nuances with irritation. We may need to do some histology to characterize a bit better the reaction that’s going on," Parker explained. But for devices such as catheters, bone screws, and pacemakers, those are eligible.
ASCA labs and methods
Parker mentioned that while MEM Elution Cytotocity is included for now, other cytotoxicity methods such as the MTT and NRU may one day be added.
FDA requires training for labs for technicians, study directors, and trainers. Study directors must build up significant education, time and experience, while trainers must hold extensive experience in each technique. Proficiency evaluations ensure that the "test lab's eyes" see things the same way that accredited bodies' eyes do. “We have to provide an index of all the SOPs that are particular to the ASCA methods we’re applying for and provide all of those to the FDA,” said Parker. “We also have to supply all of our raw data sheets that we use for collecting data on a study, all of our protocols, and report templates to make sure we’re asking for the right data, we’re recording the right amount of data, and we’re reporting the right amount of data.”
Control over sample prep is key—times, temperatures, etc. Any post extraction changes that take place such pH drops or rusting may require manipulation to proceed with testing, "but then you’re not performing a standard method anymore as there could be things going on with the device that are unexpected,” he said. At that point, the FDA would likely prefer the full report versus the summary version.
- The brand owner will need to prepare a DOC that includes where and when testing was performed, how test articles compare to predicate, and issues brought up by the lab that needed to be resolved. If anything was questionable, such a result that technically passed but that the lab notes from experience (in seeing thousands of devices) that it may be indicative of a future issue, then discussion of this—as well as any adverse or unusual findings—should be included.
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- If all testing is performed without issues, manufacturers receive a lab’s “stamp of approval” and then they may see expedited timelines in approval of their submission.
- Parker said he hopes for the entire industry—manufacturers, tests labs, and the FDA—to gain consistency in how they perform testing and report data through ASCA. Additionally, this represents a new open channel between FDA and test labs to get questions answered and innovate together.