New US FDA 510(k) Draft Guidance for Deciding When to Submit a 510(k) for a Change to an Existing Device:

udklipAre you currently a manufacturer doing business within medical devices in the USA and is your product cleared by the FDA as a 510(k)?

Then you need to be aware of that the FDA on August 8 has issued an updated draft guidance for manufacturers deciding whether to submit a new 510(k) when making modifications to medical devices already in the market.

Furthermore, a complementary draft guidance on software modifications was also issued.

The updated FDA guidance retains the basic format and content of the original guidance issued by the FDA in 1997, but with updates for clarity. FDA also drew from existing policy and related guidance in updating the draft guidance document, including:

Modifications made with intent to significantly affect safety or effectiveness of a device – If a manufacturer modifies their device with the intent to significantly improve the safety or effectiveness of the device (for example, in response to a known risk, adverse events, etc.), a new 510(k) is likely required. Changes that are not intended to significantly affect the safety or effectiveness of a device, however, should still be evaluated to determine whether the change could significantly affect device safety or effectiveness.

“Could significantly affect” evaluation and the role of testing – To determine whether a change or modification could significantly affect the safety or effectiveness of a device, the manufacturer should first conduct a risk-based assessment, of whether the change could significantly affect the device’s safety or effectiveness, either positively or negatively. This risk-based assessment should identify and analyze all new risks and changes in known risks resulting from the device modification, and lead to an initial decision whether or not a new 510(k) is required. If the initial decision following the risk assessment is that a new 510(k) is not required, this decision should be confirmed by successful, routine verification and validation activities. If routine verification and validation activities produce any unexpected issues, any prior decision that a new 510(k) is not required should be reconsidered.

Unintended consequences of changes – In evaluating whether a change requires a new 510(k), manufacturers should consider whether there are any unintended consequences or effects of the device change. For example, changes in sterilization may unintentionally affect device materials, or changes to materials may unintentionally affect the performance of the device.

Use of risk management – The risk profile is based upon the combination of multiple risk concepts which are important for managing the risks of medical devices. Hazards and hazardous situations, risk estimation, risk acceptability, risk control, risk/benefit analysis and overall risk evaluation are all concepts that can be applied during the design and development of a medical device.

Evaluating simultaneous changes
– Because many simultaneous changes may be considered at once, each change should be assessed separately, as well as in aggregate.

Appropriate comparative device and cumulative effect of changes – In using the guidance to help determine whether a particular change requires the submission of a new 510(k), manufacturers should make a risk-based assessment that compares the changed device to their device as previously found to be substantially equivalent in their most recently cleared 510(k) (or to their preamendments device, if no 510(k) has been cleared). Manufacturers may make a number of changes without having to submit a new 510(k), but each time they make a change, they should compare it to their most recently cleared device. When the manufacturer compares the proposed modified device to the device in its most recently cleared 510(k), the manufacturer should evaluate the cumulative impact of all changes since their most recently cleared 510(k).

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Types of changes that may require a new 510(k)
The guidance divides types of changes that may require a new 510(k) into three categories:

Labeling changes – such as reuse of a device previously labeled for single use only, change in a device availability from prescription to over the counter, changes that introduce a new therapeutic claim, or that introduce the device to a new patient population would generally require a new 510(k) – on the other hand changes such as changes to a device name or description that are still in line with the product’s current indications for use, or changes for clarity or readability that do not affect a device’s cleared indication for use would typically not require a new 510(k).

Technology, engineering and performance changes – such as a change in control mechanism going from analog to digital control of a medical device, change in operating principle in changing the image reconstruction algorithm used in a computed tomography x-ray system from simple back projection to a new, more radiant-efficient method, changes in energy type going from emitting microwave energy to RF would generally require a new 510(k) – on the other hand changes such as changes in device packaging or changes in the expiration date for use of a device would generally not require a new 510(k).

Material changes – such as change in material type, material formulation, chemical composition or the material’s processing generally would require a new 510(k) due to the fact that the biocompatibility and physical properties of a finished device depend not only on the materials, but also on the processing of the materials, manufacturing methods and the manufacturing residuals that may be present on the finished device – on the other hand if the manufacturer has used the same material in a similar legally marketed device and there is no postmarket evidence of biocompatibility issues with the device, that may provide evidence that the material will be biocompatible in its new application – in which case the changed device would generally not require a new 510(k).

The guidance includes flow charts for all three types of device changes, i.e. labeling, technology, engineering and performance and materials. The guidance also incorporates a number of examples for when a new 510(k) is required or changes which are considered to be enough to document the change to file.

Proper FDA clearance is essential for avoiding regulatory delays and expenses. Let us help you get it right the first time and get your product cleared for sale as quickly as possible.

Whether you need a quick assessment or a more thorough investigation, please do not hesitate to contact us for more information on the new FDA 510(k) requirements.

Randi Hauerberg
Pricipal Advisor/Team Lead – Regulatory Affairs & Quality Management
Direct (+45) 22 47 01 55

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RandiHauerberg_DarkBackgroundRandi Hauerberg came on board as Pricipal Advisor/Team Lead – Regulatory Affairs & Quality Management on March 1, 2016. Randi has more than 25 years’ experience within Regulatory Affairs