Understanding the FDA ASCA Program

In this recap blog, I will provide you with an overview of our webinar “Understanding the FDA ASCA Program”, a new pilot program. Though this blog will highlight the major points made, you can always watch the presentation and Q&A session in detail here.

Before we go into the content of the webinar, I’d like to present our speaker:

Jason Stine is the Senior Director of Accreditation at ANSI National Accreditation Board (ANAB). Jason is in charge of accreditation activities relating to testing laboratories and supporting programs accredited by ANAB. He has worked for ANAB and has been qualified as a Lead Assessor for over 15 years performing hundreds of assessments. Jason has a degree in Mechanical Engineering Technology from Purdue University and over 10 years of technical experience working in various accredited testing laboratories before ANAB. He is involved with technical organizations such as ASTM, ASQ, SAE, AOAC, ACIL and works closely with many state and federal agencies such as the EPA, FDA, CPSC, and DoD on technical and accreditation-related programs. He is actively involved in representing ANAB internationally and nationally in accreditation activities with APAC, IAAC, ILAC, and NACLA. He is the ANAB APAC delegate for MRA council lab-related decisions. Also, he is a trained and qualified ISO/IEC 17011 APAC lead evaluator.

What were the goals of ASCA?

The FDA had a few goals in mind when developing this program. They wanted to enhance confidence in medical device testing, promote consistency and predictability in the premarket review process, encourage effective use of FDA resources, enhance regulatory efficiency, and support international harmonization. And, best of all, it saves you time during the FDA review and approval process!

The ASCA Program Overview

As an ASCA-accredited testing laboratory, you will conduct testing under ISO 17025 and the ASCA program specifications. Then, the testing laboratories can use accredited testing to provide data used to determine the conformance of a device. At that point, the testing performed by an ASCA-accredited testing laboratory can be used to support a premarket submission for any device if the testing was conducted using an eligible FDA-recognized consensus standard and test method.

Another thing to note is that device manufacturers may choose to use an ASCA-accredited testing laboratory to conduct testing for premarket submissions to FDA. Also, FDA generally will accept determinations from ASCA-accredited testing laboratories (i.e., test results) when accompanied by a DOC and appropriate supplemental documentation.

Accreditation Bodies

The primary role of accrediting bodies within the program is to accredit testing labs using ISO/IEC 17025 and the ASCA program specifications associated with each recognized FDA consensus standard and testing method within their scope. A qualification for an accrediting body is that they have to be a signatory to the ILAC Mutual Recognition Arrangement (MRA). They also have to be based in the United States and they have to formally agree to the terms of participation that the FDA lays out in the guidance document.

Testing Laboratories

ASCA-accredited testing labs perform testing under ISO/IEC 17025 and the ASCA program specifications associated with each FDA-recognized consensus standard and test method in their scope of ASCA Accreditation. After the testing is complete, ASCA-accredited testing labs provide the information listed in the relevant ASCA program specifications (including an ASCA summary test report) to the device manufacturer. For a testing laboratory, it’s a two-part application process. First, the laboratory becomes accredited by ANAB for the ASCA program and then, once you’ve received accreditation, you would fill out and submit an FDA application to be approved.

Basic Safety and Essential Performance

The first document Jason walked us through is the Basic Safety and Essential Performance document, which is very specific to a set of consensus standards that the FDA has approved for use within this program.

Specific Program Requirements

In addition to ISO/IEC 17025 requirements, the pilot program has several FDA specific requirements:
Impartiality;

• Personnel data (like qualifications and expectations);
• Equipment;
• Review of requests and contracts;
• Selection, verification, and validation of methods;
• Reporting of results.

ANAB Assessment

As part of the program, the FDA has also included requirements for the accrediting body assessment. They are required to assess a sample of the ASCA program scope at least every two years. It’s expected that as this program moves forward, ANAB will focus on the ASCA program during the reassessment year. That may change, however, depending on when laboratories come in and when they added the program as part of their accreditation.

Biocompatibility Testing

This is the second program available through the ASCA pilot. This program’s requirements are similar to those of the Basic Safety and Essential Performance program but contain a few differences:

• Impartiality;
• Personnel/Qualifications (very specific requirements);
• Facilities and environmental conditions;
• Equipment;
• Metrological Traceability;
• Extra selection, verification, and validation of methods;
• Sampling;
• Ensuring Validity of Results;
• Reporting of results.

In this program, your laboratory must also consider and apply the FDA’s International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”

Another important note for this program is that the FDA has made it very clear that the assessment process must assess all (and not just a sample of) biological evaluation standards and test methods at least every two years.

FDA Review

The ASCA program provides the FDA increased confidence in the methods used and results reported by ASCA-accredited testing labs. Additionally, the FDA intends to rely on the results from ASCA-accredited laboratories for premarket review without the need for additional information related to conformance with a standard.

FDA Audits

As part of the program, the FDA plans on conducting periodic audits to ensure that they are adequately fulfilling program expectations. The audits may include anything from a review of ANAB Assessment Reports to an observation of ANAB Assessments or even an FDA onsite audit.

Conclusion

After Jason’s presentation, Karen Arriviallage gave a short demo of Qualtrax. She explained the way our eQMS helps solve compliance and accreditation issues for manufacturers and medical device organizations. If you’d like to see the whole presentation, you can view it here. The Q&A session at the end is a must-see!

If you’d like to know more about Qualtrax, you can schedule a demo or free trial here. We’d be happy to answer any questions you may have and help you be confident in your compliance.

Categories: Audits, Manufacturing, Process Management, Quality Managers

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