FDA towards the ISO 13845 international standard

The US Food and Drug Administration (FDA) has published a long-waited proposal to harmonise the quality system of medical devices (QRS) based on the 21 CFR Part 820 standard with the ISO 13485 international standard, i.e. the international standard for the quality management systems for medical devices. Let’s start with order.

What is ISO 13485?

The ISO 13485 “Medical devices — Quality management systems — Requirements for regulatory purposes” is an international standard enabling organisations to demonstrate that their ability to provide medical devices and relevant services complies with the clients’ requirements as well as with the regulatory requirements applicable to the said medical devices. 

It is, therefore, a standard that was designed to be used as basic reference for Quality Management Systems in the frame of regulatory procedures regulating the design, manufacturing and marketing of medical devices.

Though being similar to ISO 9001 in many parts, the ISO 13485 standard introduces some specific requirements, including:

• A risk management through all product manufacturing steps
• Greater control of the documents to be submitted and stored
• A focus on the achievement of the market requirements, instead of the more generic “customer satisfaction” provided for by ISO 9001
• A focus on the stability and completeness of the system and its continuous improvement.

Though ISO 13485 standard is applied on a voluntary basis, its drafting was affected by the biggest world medical device regulatory bodies. And this is why the adhesion to the standard is very much appreciated by Authorities.

In the EU, this standard – namely, version EN ISO 13485:2016/A11:2021 – was harmonised; this means that its use allows manufacturers to obtain a presumption of conformity for the General Safety and Performance Requirements of the EU Regulation on medical devices (2017/745) and EU Regulation for in vitro diagnostics (2017/746) affected by the standard.

The goal of the Medical Device Single Audit Program

The FDA proposal to harmonise 21 CFR 820 with ISO 13485 will have several benefits including, among others, the acknowledgement of the ISO 13485 also in the Medical Device Single Audit Program in Australia, Brazil, Canada and Japan.

What is the Medical Device Single Audit Program (MDSAP)?

The goal of the MDSAP is to develop, manage and supervise a single audit program allowing medical device manufacturers to have a single regulatory audit, carried out by a certification body acknowledged by the MDSAP, to meet the needs of more legal jurisdictions.

Actually, the adoption of the MDSAP program enables medical device manufacturers whose activities cover international markets to spare costs and time related to the Quality Management System and to make more efficient the entry of their active medical devices in big, important markets such as Australia, Brazil, Canada, USA and Japan.

Moreover, the adoption of the MDSAP allows a substantial reduction of the time and total costs of inspection’s controls.

MDSAP offers a unique opportunity to manufacturers, as it was created to cover the existing ISO 13485 standards and the specifications of the various countries; this means that manufacturers adapting to the MDSAP will automatically be in line with local regulations as well as with ISO 13485.

Thanks to their long-time experience, Di Renzo Regulatory Affairs can support you in the creation/update/maintenance of your company’s quality management system according to ISO 13485 and in compliance with the provisions of Regulations EU 745/2017 and 746/2017.

Written by: Felisiano Cipressi

Foto di fernandozhiminaicela da Pixabay