FDA ASCA Pilot Program (Basic Safety And Essential Performance)

The FDA ASCA Pilot Program (Basic Safety and Essential Performance) is a certification program that is used to evaluate and certify the safety and effectiveness of medical devices. The program is operated by the Food and Drug Administration (FDA), which is a US government agency that is responsible for regulating the safety and effectiveness of medical devices.

The ASCA Pilot 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. To participate in the program, manufacturers must submit a premarket notification (510(k)) to the FDA, which must include data and information demonstrating that the device meets the program's requirements.

The ASCA Pilot Program is a voluntary program, and manufacturers may choose to participate in order to demonstrate the safety and effectiveness of their products to regulatory bodies, customers, and other stakeholders. Participation in the program can also help to improve the quality and reliability of medical devices, and may lead to increased confidence in the safety and effectiveness of these products.

The U.S. Food and Drug Administration administers the Accreditation Scheme for Conformity Assessment (ASCA) Pilot program, and United States Accreditation, INC. It has completed its preparations and is in the application process to be recognized as an Accreditation Body for laboratories conducting pre-market tests for medical device companies.

This voluntary program is intended to enhance product reviewers and device manufacturers confidence in medical device testing through third-party laboratory assessment and accreditation, easing the complex process of pre-market authorization by allowing medical device manufacturers the option to utilize accredited testing laboratories to ensure that data submitted to regulators is met with both confidence and acceptance.

FDA has established the ASCA Pilot Program requirements to describe the process that an organization must follow to have its facility recognized. We are recognized to accredit laboratories globally to this program.

This specialty program is covered under our electrical field of testing.

General/Program Requirements

• ISO/IEC 17025 General Requirements for the Competence of Testing and Calibration Laboratories
• Requirements in FDA ASCA Pilot Program and Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment