USFDAs Center for Devices and Radiological Health and Center for Biologics Evaluation and Research released multiple draft guidance related to medical devices and the Accreditation Scheme for Conformity Assessment (ASCA) Program.
The Accreditation Scheme for Conformity Assessment (ASCA) Program is a voluntary program established by the USFDA to standardize the conformity assessment processes of medical device testing. The goal is to improve the efficiency and predictability of regulatory submissions, particularly by leveraging recognized consensus standards and accredited testing laboratories.
By incorporating elements, where appropriate, from a well-established set of international conformity assessment practices and standards (e.g., ISO/IEC 17000 series), FDA believes the voluntary ASCA Program can help facilitate the international harmonization of medical device regulations. The voluntary ASCA Program does not supplant or alter any other existing statutory or regulatory requirements governing the decision-making process for premarket submissions.
In this draft guidance document, the FDA provides recommendations regarding analytical chemistry testing for the assessment of biocompatibility of medical devices. In general, this guidance applies to the testing of analytical chemistry on medical devices. The materials used in a particular device or the historical approach to the device may require a different method.
Chemical characterization is one approach that manufacturers can consider when developing a strategy for the overall biocompatibility assessment of a device. The recommendations in FDA-recognized consensus standards or device-specific guidances should also be followed if those standards address chemical analysis of a specific type of device. In order to facilitate efficient review of analytical chemistry studies in medical device submissions, the recommendations in this guidance are intended to promote consistency.
Guidance: Biocompatibility Testing of Medical Devices - Standards Specific Information for the t (ASCA) Program
Biocompatibility refers to the ability of a material to perform with an appropriate host response when used in a medical device or contact with human tissue. It is a critical factor in the design and development of medical devices that come into contact with the body, either internally (such as implants) or externally (like skin patches). The goal of biocompatibility testing is to ensure that the material does not cause harmful effects, such as toxicity, inflammation, or immune reactions, when used in medical applications.
The Biocompatibility Testing of Medical Devices guidance under the Accreditation Scheme for Conformity Assessment (ASCA) Program outlines the specific standards that accredited laboratories must follow when conducting biocompatibility testing. This is a vital aspect of ensuring that medical devices are safe for human use by assessing how materials in contact with the body interact biologically.
Guidance: Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment - Standards Specific Information for the ASCA Program
This guidance provides detailed instructions for applying the Accreditation Scheme for Conformity Assessment (ASCA) to medical electrical and laboratory medical equipment. This program aims to streamline the FDA’s review of medical devices by accepting testing conducted under recognized international standards.
This guidance is particularly important for manufacturers developing medical electrical devices and laboratory medical equipment, as it ensures that essential safety and performance testing aligns with FDA expectations, helping to streamline the approval process.
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