In September 2020 FDA published some “Final Guidance Document” for companies operating in Medical Devices field.

Published final version ISO 10993 guideline

On September 4, 2020 FDA published the updated guide on the ISO 10993 for the biocompatibility of Medical Devices. The document which replaces the guide finalized in 2016, specifically addresses to the ISO 10993-1 “Biological evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process”.

This guide is useful for the Manufacturer as it explains how the standard ISO 10993 should be used for biological assessments of Medical Devices.

Some key points of the guide are as follows:

• Risk assessment to be used in biocompatibility assessments;
• Use of the ISO 10993-1 together with FDA specific requirements;
• General considerations on biocompatibility tests;
• Considerations on testing for specific areas;
• Recommendations for chemical characterisation.

Clinical trial guidelines during COVID-19

On September 21, 2020 FDA published the “FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency” guide, useful to ensure the safety of participants in clinical trials of medical products and to answer questions received on the conduct of clinical trials during the COVID-19 health emergency.

The document draws attention to:

• utmost importance to the safety of participants in clinical trials to determine whether changes in the conduct of studies are necessary;
• methods for monitoring the experimentation.

ASCA program

The ASCA pilot program (Accreditation Scheme for Conformity Assessment) allows to evaluate statements of compliance of Medical Devices with the standards recognized by the FDA.

On September 25, 2020 FDA published 3 final guidelines for the ASCA project covering:

• The objectives, roles, responsibilities and procedures of the ASCA pilot program;
• Basic safety and essential performance of electromedical equipment, electromedical systems and medical laboratory equipment;
• Indications on how the standards of biological evaluation of Medical Devices are incorporated into the ASCA pilot program.

The 3 final guidelines replace the single draft guideline issued by FDA on September 2019.  

Thema constantly monitors updates published by FDA and offers strategic-regulatory consulting services to companies operating in the Medical Devices sector.

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Sources:

“Use of International Standard ISO 10993-1, “Biological evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process” – published on September 4, 2020 – https://www.fda.gov/media/85865/download

“FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency” – published on September 21, 2020 – https://www.fda.gov/media/136238/download

“The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program” – published on September 25, 2020 – https://www.fda.gov/media/130901/download

“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) Pilot Program” – published on September 25, 2020 – https://www.fda.gov/media/142385/download

“Biocompatibility Testing of Medical Devices – Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program” – published on September 25, 2020 – https://www.fda.gov/media/142388/download