EMERGO SUMMARY OF KEY POINTS:

• US FDA has issued final guidance documents for changes to medical device hardware and software that require new 510(k) applications.
• The final guidances do not differ substantially from draft versions published in 2016.

Medical device regulators at the US Food and Drug Administration have published final guidance explaining when changes to registered devices warrant filing new 510(k) premarket notifications to the agency.

The FDA’s final guidances for device hardware and software follow draft guidance issued in August 2016 covering changes to a registered device’s hardware and software that necessitates new 510(k) clearance; the final guidances states that they contain no major FDA policy changes, but are intended to support more consistent and predictable “when to submit” decisions by US market registrants.

Changes that may require new 510(k) filings

As covered in the draft FDA guidance, the final guidance states that any hardware change intended to improve a device’s safety or effectiveness requires a new 510(k) application. Changes to labeling; technology, engineering or performance; or materials may also require new premarket notification submissions.

For device software, FDA requires submission of new 510(k) applications in the following instances:

• Change introduces a new risk or modifies an existing risk that could potentially result  in significant harm; the new or modified risk is not mitigated in the currently cleared version of the device
• Change causes the need for a new risk control measure or modification to a current control measure to address a potentially dangerous situation that could cause significant harm
• Change significantly affects clinical functionality or performance specifications directly tied to the device’s intended use

In instances where software changes are made only to improve a device’s cybersecurity or only to return a device’s system to the specifications of its most recently cleared version, registrants should document those changes and consider them when determining whether to file new 510(k) applications.

Related FDA 510(k) information from Emergo:

• FDA 510(k) consulting for medical device companies
• Medical device design, process and software validation consulting
• Cybersecurity support for connected medical devices and software
• Whitepaper: Preparing a US FDA 510(k) submission