SGS Fimko Oy Becomes an ASCA Accredited Testing Laboratory TL 161

SGS Fimko Oy’s testing laboratory has successfully passed the evaluation under the U.S. Food and Drug Administration’s (FDA) ASCA program.

The SGS Fimko Oy testing laboratory has completed the FDA’s Accreditation Scheme for Conformity Assessment (ASCA) evaluation and is now listed in the FDA’s official database. SGS Fimko Oy is the first European SGS laboratory to be granted ASCA accreditation and is currently the only ASCA accredited SGS laboratory. The accreditation identifier of SGS Fimko Oy is TL 161.

ASCA accreditation is based on the Accreditation Scheme for Conformity Assessment, developed by the U.S. Food and Drug Administration (FDA). It is a voluntary program in which testing laboratories undergo additional qualification and follow standardized reporting procedures. The objective is to enable test reports issued by accredited laboratories to be used more efficiently in the premarket approval of medical devices.

The ASCA program is based on internationally recognized standards (including IEC 60601, IEC 61010, and ISO 10993) and is intended primarily for medical device manufacturers and testing laboratories.

What Is Required of a Medical Device Entering the U.S. Market?

The FDA requires manufacturers to demonstrate the safety and performance of a medical device before it can be commercially marketed. The specific process depends on the device’s risk classification, but the general requirements include:

• The device’s risk class must be determined
• The appropriate premarket submission pathway must be selected
• The manufacturer must have an FDA compliant quality management system
• The device must be tested in accordance with FDA recognized consensus standards
• The device must be registered and listed with the FDA
• The manufacturer must have an established post market surveillance system

What Are the Benefits of ASCA Accreditation?

• Faster and smoother FDA approval processes
  The FDA trusts the test methods used by ASCA accredited laboratories and generally does not request additional clarification on testing during the approval process.

• Harmonized test methods and higher quality test reports
  Variations in testing methods have previously led to errors and inconsistencies, particularly for complex devices. The ASCA program reduces this variability by ensuring that testing is conducted using the same methods and standards, regardless of the laboratory.

• Improved patient safety and device quality
  The ASCA program strengthens the reliability of test results through internationally recognized standards and increases the predictability of FDA reviews. This enhances confidence that devices placed on the market meet safety and performance requirements.

How Can SGS Help?

The FDA accepts ASCA Summary Test Reports produced by ASCA accredited laboratories as part of premarket submissions. When testing is performed in an ASCA accredited laboratory using FDA recognized standards, the FDA’s need to request additional information on test methodologies is reduced—accelerating time to market.

SGS can perform the required standards compliant testing and provide the ASCA Summary Test Report to the manufacturer. The manufacturer then includes these reports in the FDA premarket submission.

SGS testing laboratory TL 161 is accredited to test electrical safety, performance, and electromagnetic compatibility (EMC) of medical devices.

Contact us to learn more about our medical device services and how ASCA accreditation can help accelerate your market access.