The Accreditation Scheme for Conformity Assessment (ASCA) Program for Medical Device Testing Laboratories (DRAFT)
The guidance outlines the Accreditation Scheme for Conformity Assessment (ASCA) Program, which is designed to improve the efficiency of premarket review processes by building confidence in Declarations of Conformity (DOCs) and associated documentation produced by accredited testing laboratories. The program establishes processes for FDA to recognize accreditation bodies and accredit testing laboratories for conducting testing according to FDA-recognized consensus standards and test methods.
This is a draft guidance. Not for implementation.
What You Need to Know? 👇
What is the ASCA Program and how does it benefit medical device manufacturers?
The ASCA Program is a voluntary conformity assessment scheme that allows FDA-recognized accreditation bodies to accredit testing laboratories for medical device testing. It increases confidence in test results and may reduce FDA requests for additional information during premarket review.
How long does the ASCA application process take for testing laboratories?
FDA reviews applications for ASCA Accreditation within 60 calendar days. Testing laboratories must first obtain accreditation from an ASCA-recognized accreditation body before applying to FDA for ASCA Accreditation status.
What happens if an ASCA-accredited testing laboratory’s accreditation is suspended?
During suspension, the testing laboratory must state that affected test results were conducted during a period of suspension. Device manufacturers cannot submit ASCA DOCs for suspended standards, and FDA may request additional information for premarket review.
Can device manufacturers use internal testing laboratories for ASCA accreditation?
Yes, a device manufacturer’s internal testing laboratory is eligible for ASCA Accreditation. FDA applies the same qualification criteria and processes to internal laboratories as any other testing laboratory seeking ASCA participation.
What are the key requirements for accreditation bodies to participate in ASCA?
Accreditation bodies must be ILAC MRA signatories with ISO/IEC 17025 scope, be based in the United States, demonstrate technical competence in relevant FDA-recognized standards, and execute a signed agreement with specific participation terms.
How does FDA audit ASCA participants and what are the different audit levels?
FDA uses a three-tiered audit approach: Level 1 leverages existing reports and requests information, Level 2 involves FDA observing scheduled assessments, and Level 3 consists of FDA-initiated on-site or remote audits for highest concern issues.
What You Need to Do 👇
Recommended Actions
- For Accreditation Bodies:
- Apply for ASCA Recognition if qualified
- Maintain ILAC MRA signatory status
- Develop processes to assess testing laboratories according to ASCA requirements
- Complete required FDA training
- Establish communication procedures with FDA
- For Testing Laboratories:
- Obtain accreditation from an ASCA-recognized accreditation body
- Apply for ASCA Accreditation for relevant standards
- Complete required FDA training
- Implement processes to meet ASCA Program specifications
- Maintain appropriate documentation and communication with FDA
- For Device Manufacturers:
- Identify appropriate ASCA-accredited testing laboratories
- Work with laboratories to develop appropriate test plans
- Include required ASCA documentation in premarket submissions
- Monitor testing laboratory’s ASCA Accreditation status
- Maintain appropriate documentation of testing results
- For FDA Staff:
- Review ASCA applications according to established timelines
- Conduct periodic audits of accreditation bodies and testing laboratories
- Review premarket submissions containing ASCA documentation
- Maintain communication with program participants
- Take appropriate action if issues are identified
Key Considerations
Non-clinical testing
- Testing must be conducted according to FDA-recognized consensus standards and test methods within the testing laboratory’s scope of ASCA Accreditation
- Testing laboratories must maintain accreditation from an ASCA-recognized accreditation body
- Testing must be conducted in accordance with ISO/IEC 17025 and ASCA Program specifications
Biocompatibility
- Testing must be conducted according to FDA-recognized biocompatibility standards within scope of ASCA Accreditation
- Testing laboratories must follow ASCA Program specifications for biocompatibility testing
Safety
- Testing must be conducted according to FDA-recognized basic safety and essential performance standards within scope of ASCA Accreditation
- Testing laboratories must follow ASCA Program specifications for safety testing
Other considerations
- Testing laboratories must provide ASCA summary test reports and complete testing reports to device manufacturers
- Device manufacturers must include ASCA DOCs and supporting documentation in premarket submissions
- FDA may suspend or withdraw ASCA Accreditation if issues are identified
- Testing laboratories must maintain appropriate communication with FDA
- All ASCA documentation must be provided in English
Relevant Guidances 🔗
- Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program for Medical Device Testing Laboratories
- Basic Safety and Essential Performance Standards for Medical Electrical Equipment Under the ASCA Pilot Program
- Biological Evaluation of Medical Devices Standards in the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program
- Basic Safety and Essential Performance Standards in the Accreditation Scheme for Conformity Assessment (ASCA) Program (Draft)
- Biocompatibility Testing Standards and Accreditation Requirements in the ASCA Program (Draft)
Related references and norms 📂
- ISO/IEC 17025:2017: General requirements for the competence of testing and calibration laboratories
- ISO/IEC 17011:2017: Conformity assessment – Requirements for accreditation bodies accrediting conformity assessment bodies
- ISO/IEC 17000:2004: Conformity assessment – Vocabulary and general principles