The FDA Is Adopting ISO 13485: What This Means for Medical Devices

by t_king

medical devicesThe FDA has long wanted to harmonize its medical device QSR (21 CFR 820) with ISO 13485. This adoption is expected to ease the burden of medical device registration and compliance to both domestic and international requirements. The last update for QSR (21 CFR 820) was in 1996, the FDA was accepting comments on the proposed rule through May 24th.

What does this mean for QSR (21 CFR 820) and 21 CFR 820? The FDA is currently in the process of finalizing guidance that will help manufacturers transition from QSR (21 CFR 820) to ISO 13485. Once finalized, this guidance will provide a voluntary pathway for companies to follow in order to show compliance with both QSR (21 CFR 820) and ISO 13485.

What are the benefits of this transition? There are many potential benefits for both medical device companies and the FDA, including:

  • Reduced burden on medical device companies, who will no longer need to maintain compliance with two separate sets of requirements
  • Improved alignment between the FDA’s QSR requirements and international standards
  • Greater harmonization between the US and global markets, making it easier for companies to do business internationally
  • Increased confidence in the safety and efficacy of medical devices sold in the US, as they will have been manufactured according to the highest international standards.

What are the challenges of this transition? While there are many potential benefits to transitioning to ISO 13485, there are also some challenges that companies will need to be aware of, including:

  • The need to invest in training and resources to ensure compliance with the new standard
  • The possibility of increased costs associated with manufacturing medical devices to the higher ISO 13485 standards
  • The potential for disruptions to business as usual during the transition period.

Despite these challenges, the FDA believes that the benefits of transitioning to ISO 13485 outweigh the challenges. The agency is committed to working with medical device companies to help them make a smooth transition to the new standard.

If you have any questions about how this transition might affect your company please don’t hesitate to contact us!