18/10/2024
On September 15, 2024, the FDA updated three draft guidelines related to ASCA (Basic Safety and Essential Performance), a voluntary programme that allows medical device manufacturers to use ASCA-accredited laboratories to perform tests to be included in pre-market applications for US market access.
Objectives of the ASCA Programme
ASCA is designed to simplify the documentation required to demonstrate compliance through the use of ASCA summary test reports. The guidelines aim to transform ASCA from a pilot initiative to a permanent programme, introducing improvements based on the feedback received during the pilot phase and the agency’s commitment outlined in the Medical Device User Fee Amendments 2022 (MDUFA V).
The guidelines reflect updates from meetings, webinars and stakeholder meetings, as well as lessons learnt during the pilot phase. Once final, these guidelines will replace the three ASCA pilot guidelines published on September 25, 2020. To participate in the programme, manufacturers must submit a pre-market notification (510(k)) to the FDA, which must include data and information demonstrating compliance with the programme requirements.
Overview of updated guidance
- The Accreditation Scheme for Conformity Assessment (ASCA) Program:
ASCA programme for conformity assessment; this guidance outlines the programme’s objectives and procedures, highlighting the importance of an appropriate framework to support the agency’s efforts to make efficient use of scientific resources for the benefit of public health. - Biocompatibility Testing of Medical Devices – Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program:
Biocompatibility Testing of Medical Devices; this guidance provides details on how biological evaluation standards are integrated into the ASCA programme. The new draft runs to 168 pages, an increase of over 100 compared to the previous document, offering more detailed information on test methods, ASCA specifications and summary reports. It includes new sections on competence requirements for technical assessors of accreditation bodies, the scope of ASCA accreditation and recommendations for testing laboratories. The guide emphasises the importance of demonstrating competence and developing biocompatibility test plans. - Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment – Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program:
Basic safety and essential performance of electrical Medical Devices and laboratory systems; this guidance focuses on the safety and essential performance of such devices. It provides information on how standards are incorporated into the ASCA programme, illustrating the importance of compliance to ensure the safety and effectiveness of devices.
Although the guidance documents are not yet finalised, it is advisable to familiarise oneself with them, as the ASCA programme represents an important opportunity for manufacturers. Among its many advantages, the reduction of regulatory burdens stands out; thanks to ASCA, manufacturers can obtain approval for their devices more quickly. The guidance documents are constantly updated based on user feedback, ensuring that they remain relevant and useful.
In conclusion, the ASCA programme not only offers practical and strategic advantages for manufacturers but also represents a significant step towards a safer and more innovative healthcare system.
>>> Thema and Thema Corp (based in the United States), are ready to assist at every stage of the strategic and regulatory process concerning Medical Devices in the US market.
