FDA ASCA Pilot Program (Biocompatibility Testing of Medical Devices)

The FDA ASCA Pilot Program (Accelerated Approval of Standards for Biomedical Technology) is a certification program that is operated by the Food and Drug Administration (FDA). The program is designed to help manufacturers of Class I and Class II medical devices to demonstrate that their products meet certain safety and performance criteria, and to expedite the review and approval process for these products.

This program applies FDA medical device guidance to biocompatibility testing methods.

For information on our FDA recognized status and current scope of ASCA Recognition see ASCA Recognized Accreditation Bodies. For consensus standards eligible for accreditation under the ASCA pilot Program see The FDA Recognized Consensus Standards Database.

"U.S. Accreditation" FDA ASCA Biocompatibility Testing Laboratory Accreditation Program encompasses laboratories performing both in-vitro and in-vivo biocompatibility testing of medical devices.

This program is one half of the FDA ASCA Pilot Program. The program page for Basic Safety and Essential Performance of Medical Devices can be found here, but you can contact us directly for more information.

This specialty program is covered by the "U.S. Accreditation" biological field of testing.

Program Requirements

• ISO/IEC 17025 General Requirements for the Competence of Testing and Calibration Laboratories
• Program guidance: The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program Final Guidance
• Biocompatibility standards-specific guidance: Biocompatibility Testing of Medical Devices- Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program

There are several potential benefits of obtaining FDA ASCA Pilot Program (Biocompatibility Testing of Medical Devices) accreditation:

1. Meeting regulatory requirements: In some cases, ASCA Pilot Program accreditation may be required in order to meet regulatory requirements or to qualify for certain contracts or business opportunities.
2. Demonstrating competence and credibility: ASCA Pilot Program accreditation can help to demonstrate the manufacturer's competence and credibility to regulatory bodies, customers, and other stakeholders.
3. Improving the safety and effectiveness of medical devices: ASCA Pilot Program accreditation can help to improve the safety and effectiveness of medical devices, which may lead to increased customer satisfaction and trust in the manufacturer's brand.
4. Reducing the risk of adverse reactions: Obtaining ASCA Pilot Program accreditation can help to reduce the risk of adverse reactions to medical devices, which can have serious consequences for patients and the manufacturer, including financial losses, damage to reputation, and legal liabilities.
5. Improving efficiency and cost savings: ASCA Pilot Program accreditation can help to identify areas for improvement in the manufacturer's biocompatibility testing processes, which may lead to increased efficiency and cost savings.
6. Enhancing the reputation of the manufacturer: ASCA Pilot Program accreditation can help to enhance the reputation of the manufacturer, which may lead to increased customer satisfaction and trust in the brand.