It’s been a long journey for FDA. The last attempt at updating the two-decades old K97-1 guidance ended in failure when the US Congress ordered FDA to go back to the drawing board following widespread opposition to a 2011 draft seen as too prescriptive and risk averse.
The new guidances still keep the basic structure of the old K97-1 but the depth is much greater – with detailed advice on a range of areas including materials and biocompatibility, labelling, and specific consideration of IVDs.
And it’s all about Risk.
The “Guiding Principle” of the new guidance is that any change which could significantly impact device safety or performance is likely to require a new 510(k). Specifically – anything intended to improve clinical outcomes or to mitigate a known risk (e.g. in response to adverse events) is presumed to require a 510(k).
It all hinges on that word “significant” and significance is to be determined by risk assessment. That’s very similar to the European approach to use of Risk Assessment for Significant Change decisions. Similar principles are used in many other markets which use the European/GHTF regulatory model.
And the guidance is clear on how that decision fits within the risk management framework of ISO 14971. A significant change occurs when ISO 14971 risk assessment identifies:
- a new hazard not present in the most recently 510(k)-cleared version of device or
- increase to risk score, raised acceptability category or extended duration of risk.
In other words: a new risk or an increased risk will likely require a new 510(k).
Everywhere you look in the new guidance, there are decisions made based on risk assessment. For example, the old guidance required submission of a new 510(k) whenever a material change resulted in biocompatibility testing. Now the manufacturer is asked to consider the nature of the new materials, whether they (or their processing) raise new risks and to either document that the changes do not impact performance specifications or to submit a 510(k).
Be careful though – in the cases of serious design faults which resulted in recall, a more conservative approach applies and the FDA K95-1 guidance on requirements for new 510(k) following recall take precedence.
What is completely new is the separate guidance on software. There’s a complicated flowchart designed to parse those changes which do or don’t require a 510(k). But the underlying message is really quite simple: Cybersecurity improvements, bug fixes and cosmetic changes can be documented, most other significant software changes will trigger a new 510(k) (see table below).
When is a Software Change “Significant”?
No 510k required
Likely to Require a new 510(k)
Bug fixes (“changes to return the system into to specification”)
Cosmetic changes (e.g. logos, fonts, colours)
New or changed hazard or hazardous situation which may cause significant harm
Need for a new or modified risk mitigation arising from a change may cause significant harm
Changes which have significant effect on clinical functionality or performance specifications associated with intended use
Other significant software changes e.g. change of operating system, language, drivers, libraries, core algorithms or system architecture, any other significant software rewrite.
These guidances bring a wealth of practical assistance. The extensive use of risk assessment provide a framework for documenting minor changes and justifying that their impact doesn’t change the risk profile of the device. There’s clarity here for regulators and reviewers alike.
The clear use of ISO 14971 frameworks will bring US requirements more closely into line with all those other jurisdictions which use a risk based “Significant Change” determination for deciding when to seek review of Conformity Assessment. Changes which require review in Europe are now more likely to align with changes requiring a new 510(k) and vice versa.
Need help with FDA strategy or filings? Still grappling with Significant Change? We are experienced in preparation and filing of 510(k), including de novo submissions and FDA pre-consultations. Contact us today for a no-obligation chat on how we may help you. Email email@example.com or call +61 2 9906 2984.