With the recent publication of two guidance documents, the FDA has better defined under what circumstances it is necessary to submit a new Premarket Notification 510 (k) for changes to a medical device or software.

These guidance documents aim to enhance the consistency and transparency of the decision-making process underlying the 510(k) submission.

As regards Medical Devices, the guidance replaces the 1997 previous document and unambiguously defines the changes in terms of design, components, formulation, supply, production process or intended use of the product which are the reason for submitting a new 510(k).

As regards medical software, design changes include: bug fixes, hot fixes, patches, software changes, code modifications.


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