Understanding the ASCA FDA Program and PJLA’s Role in Accreditation

The medical device industry operates in a highly regulated environment where compliance with safety and performance standards is critical. To streamline the testing and approval process, the U.S. Food and Drug Administration (FDA) established the Accreditation Scheme for Conformity Assessment (ASCA) Program. This voluntary initiative aims to enhance the efficiency of regulatory submissions for medical devices by leveraging accredited testing laboratories. Perry Johnson Laboratory Accreditation, Inc. (PJLA) is proud to be an FDA-recognized Accreditation Body that plays a vital role in supporting this program.

What is the ASCA FDA Program?

The ASCA FDA Program is designed to ensure that medical device testing follows FDA-recognized consensus standards. By working with accredited laboratories, device manufacturers can improve the consistency of testing, minimize regulatory delays, and facilitate a smoother premarket review process.

Scope of the ASCA Program

The ASCA program primarily covers two critical areas of medical device testing:

• Biocompatibility Testing – Ensures that materials used in medical devices are safe for patient contact.
• Electrical Safety Testing – Evaluates the safety of electrical medical devices to prevent hazards such as electric shocks or malfunctions.

Key Aspects of the ASCA Program

• Accredited Laboratories: Only laboratories accredited by FDA-recognized Accreditation Bodies, such as PJLA, are eligible to conduct ASCA testing.
• Standardized Testing: Ensures consistency in test results by adhering to FDA-recognized consensus standards.
• Faster Regulatory Review: Device manufacturers using ASCA-accredited laboratories benefit from a more efficient FDA submission process, reducing the need for redundant testing or additional evaluations.

Benefits of ASCA Accreditation

• Reduces the Burden on Manufacturers: By using ASCA-accredited test results, manufacturers can avoid re-evaluation of test data, saving time and resources.
• Enhances Confidence in Test Results: FDA recognition of ASCA accreditation reinforces the reliability and credibility of testing laboratories.
• Speeds Up Market Access: A more predictable and streamlined regulatory process allows manufacturers to bring medical devices to market faster.

PJLA: A Recognized Accreditation Body for ASCA

PJLA is one of the FDA-recognized Accreditation Bodies responsible for evaluating and accrediting laboratories under the ASCA Program. We ensure that testing laboratories comply with the stringent requirements of ISO/IEC 17025, which outlines the general requirements for the competence of testing and calibration laboratories.

How to Obtain ASCA Accreditation with PJLA

Testing laboratories interested in ASCA accreditation must undergo an assessment process to demonstrate compliance with FDA-recognized standards. The accreditation process with PJLA involves the following steps:

1. Application Submission – A laboratory applies to PJLA for ASCA accreditation.
2. Evaluation Process – PJLA assesses the lab’s compliance with ISO/IEC 17025 and ASCA-specific requirements.
3. Accreditation Approval – Upon successful evaluation, the lab receives ASCA accreditation and is recognized as an authorized testing facility.
4. Conducting ASCA Testing – Accredited laboratories can then perform ASCA testing under FDA-recognized standards, helping manufacturers streamline their regulatory submissions.

FDA Oversight and Compliance

The FDA maintains an active role in overseeing the ASCA program. It maintains a list of ASCA-recognized Accreditation Bodies and Testing Laboratories, conducting periodic assessments to ensure continued compliance with program requirements. This oversight reinforces the credibility of ASCA testing and ensures that accredited laboratories maintain high-quality testing standards.

Why Choose PJLA for ASCA Accreditation?

PJLA brings years of expertise in laboratory accreditation, offering a streamlined and efficient process for laboratories seeking ASCA recognition. Our dedicated team of assessors ensures that labs meet the highest standards of quality and compliance, ultimately supporting medical device manufacturers in their journey toward FDA approval.

For more information on how PJLA can assist with ASCA accreditation, contact us today and take the next step toward achieving regulatory excellence.