Regulatory Change Assessment

by | Nov 1, 2019 | 510k, FDA, Medical Devices, Quality Systems, Regulatory

Making a change to the design or the manufacturing process of your product that is already out in the field? You have some additional things to consider before making the change. Often times these changes are triggered via the customer feedback mechanisms such as the complaint handling system, post-market clinical studies or sometimes nonconformance management. This also means that you have a healthy post-market surveillance system in place.

What manufacturers forget about is that these design changes should be assessed via the regulatory framework aside from just documenting them in the QMS. A strong change control system can help you to never miss out on these details.

It is critical that your change control system ties into the regulatory assessment and has the correct triggers to drive this assessment. FDA’s guidance document ‘Deciding When to Submit a 510(k) for a Change to an Existing Device’ helps you to assess the change methodologically and will help you to decide whether FDA needs to be notified.1

The same applies to changes made to the software of the device. A separate FDA guidance’ Deciding When to Submit a 510(k) for a Software Change to an Existing Device’ is available to assess the software change. 2

Another important point to consider is how these changes may impact the risk assessment of the device. If the change introduces new risks that were not captured in the original risk management file of your product, the risk management file needs to be updated and there is a possibility that the regulatory authorities also need to be notified.

While it can be difficult to keep a check on all the possible impacts a small change to the device might have, it is important for a company to do their due diligence and assess all the possible impacts with the help of a cross-functional team.

With EMMA International’s proprietary methodology in designing quality systems, you will never have to worry about missing out on such details. Give us a call today at 248-987-4497 or email us at info@emmainternational.com to find out how we can help you.


1FDA (Oct 2017) Deciding When to Submit a 510(k) for a Change to an Existing Device retrieved on 10/24/2019 from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-change-existing-device

2FDA (Oct 2017) Deciding When to Submit a 510(k) for a Software Change to an Existing Device retrieved on 10/24/2019 from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-software-change-existing-device

Nikita Angane

Nikita Angane

Solutions Delivery Specialist - Ms. Angane is a Bioengineering graduate with experience in medical device commercialization, product development, quality system compliance and regulatory affairs. Her portfolio includes working on medical devices, combination products, and pharmaceuticals. As a Solutions Delivery Specialist at EMMA International, she offers her expertise to help our clients achieve an effective and sustainable quality system, and develop regulatory strategies for market access and compliance of new products in the US and international markets. Ms. Angane earned a Bachelor of Engineering in Biomedical Engineering from the University of Mumbai, India and an M.S. in Bioengineering from University of Illinois at Chicago.

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