Every medical device manufacturer or company knows how frequently medical devices undergo modifications to their design and materials.
There are several things that can cause this, like:
- Changes in the supply chain
- Continuous process improvements
- Technological innovations
According to the FDA guidelines, only major changes to medical devices require premarket review. A premarket notification (510(k)) is usually needed when the marketed 510(k) cleared medical device undergoes significant changes or modifications. As per the FDA 510(k) requirements, these major changes can involve modifications to the design, components, manufacturing method, or intended use.
Why do changes happen in medical devices?
Medical device changes occur for many reasons, including technological advancements, regulatory updates, and performance optimisation. Let’s explain these one by one.
#1 Technological Breakthroughs: Innovation is nonstop in the healthcare and medical device industry. As new technologies emerge, medical devices are updated or redesigned to be smarter, safer, and more effective, hence introducing the change in the existing product.
#2 Regulatory Demands: Regulations always change to ensure patient safety and medical device efficacy. Medical device manufacturing companies need to change their device to adapt and meet these new standards, which often leads to modifications or redesigns.
#3 Improved Performance: The ultimate goal is better patient care. Feedback from the field can prompt changes in the medical device design, functionality, or usability to enhance treatment outcomes.
In conclusion, change is constant in the medical device world, and it is driven by the need to stay ahead in technology, comply with evolving regulations, and deliver the best possible care.
What Procedures Are in Place for Changes in Medical Devices?
Now that we know that changes in the medical device industry are constant, it is essential to understand the processes and steps that are in place to manage these changes in medical devices.
Luckily, changes to medical devices are carefully managed through a series of procedures to ensure safety, effectiveness, and regulatory compliance.
Here’s an overview of the key steps (along with corresponding procedures) involved in change management for medical devices:
Step # 1 – Change Control:
Assessment: Any updates to the design, materials, manufacturing, or labeling need a thorough review to ensure they don’t affect the safety, performance, or regulatory status of the medical device.
Approval: A change is first reviewed and assessed through the change request process. After completion of the assessment, the change request must be approved by different stakeholders from regulatory affairs, quality assurance and engineering team to ensure that all the potential risks are considered.
Step # 2 – Development and Validation and Verification:
Testing: Laboratory testing, bench testing, clinical evaluations and software validations are a few examples of testing which needs to be done in order to verify that the modified device meets the standards of safety and performance.
Documentation: In order to demonstrate compliance with the regulatory standards, proper documentation of all test results, along with updated risk assessments and design documents must be done. This documentation must be reviewed and approved through Engineering Change Controls (ECOs).
Step # 3 – Regulatory Documentation and Submission:
Minor Changes: Internal documentation such as the “letter to file” may suffice for the devices with minor changes which do not significantly affect the safety as well as performance.
Major Changes: Significant changes, such as alterations to the device’s intended use, patient contacting materials, etc., require a formal 510(k) submission to the FDA. Which type of submission to choose depends on the nature of change. The 510(k) submission may involve providing updated documentation, risk assessments, and sometimes additional clinical data – all subjective to the extent of changes made to the originally 510(k) cleared medical device.
Step #4 – Implementation and Training:
Production Update: After validation and verification, regulatory submission of internal documentation, the changes can be introduced in the field.
Training: In case the change affects how the device is used, it is the manufacturer’s responsibility to ensure that end-users of the product, such as healthcare professionals, receive proper training on the updated device.
Step # 5 – Post-Market Surveillance:
Monitoring: After implementation is carried out successfully, the modified device is monitored through postmarket surveillance to ensure that it performs as expected in real-world settings.
Feedback Loop: Any issues identified during postmarket surveillance can trigger further changes, creating a continuous improvement loop. The change management procedures ensure that changes to medical devices are carefully controlled, minimizing risks and ensuring that the devices continue to meet regulatory and safety standards while delivering effective patient care.
What do we mean by significant changes?
Significant changes – FDA usually refers to the changes that affect the safety and effectiveness of the device as significant changes. Not just this, it also includes any modifications made to the intended use of the device. 21 CFR 807.81(a)(3)
Non – Significant changes – These do not impact the safety and effectiveness of the device, and are mostly benign, where the goal is to address minor inconveniences associated with the design or use of the device, such as bug fixes in software, etc.
A few changes that call for the new 510(k) submission
⦿ Addition of a new patient population
⦿ Transition of use environment, such as from professional to home use or hospital to ambulatory transport
⦿ Changes in frequency or duration of use
⦿ Any change that is being made in indications from prescription use to over-the-counter use – not all labeling changes need a new 510(k) though. To understand more about which labeling changes trigger new 510(k) submission, you can check our blog Medical Device Labeling Changes That Require a New 510(k) Submission
⦿ Any modification indicating a device’s compatibility with a new device, component, or accessory that was not previously cleared
⦿ Any type of modifications made in sterilisation, cleaning, or disinfection processes
⦿ Any change made in package integrity or shelflife claims
⦿ Changes in device design
⦿ Implementation of wireless communication
⦿ Adjustments to the human factors in the patient or user interface
⦿ Change in material type, formulation, or chemical compositions
⦿ Modifications to antibodies, detection reagents, critical reaction components, or conjugates for in vitro diagnostic (IVD) devices
FDA Guidelines to Determine When Modification Requires a New 510(k) Medical Device Submission
There are two different guidelines passed by the FDA to help determine what types of modifications to marketed medical devices need new 510(k) submission. The purpose of these guidelines is to clarify the changes that necessitate FDA review, improving the predictability, consistency, and transparency of the “when to submit” decision making process.
● General Modification Guidelines This is the guideline that helps determine when changes to an existing device require a new 510(k).
● Software Modification Guidelines These guidelines are tailored for software specific changes to medical devices.
After knowing all this, one thing that is clear here is that having a proper change assessment process in place can help you reduce the risk of failing in regulatory compliance requirements and ensure you do not get trapped in the maze of expensive recalls.
