Reforming the 510(k) Process: Where We Are, How We Got Here, and What's to Come
20.05.12
Create new or update existing guidances for clarity. Integrate systems and databases to make information more accessible. Issue regulation to cover previously neglected items [such as reclassified devices (515 Program Initiative) and transfer of ownership of a 510(k)].
Current State of Change
New Guidance: Changes to 510(k) products. The new draft guidance eliminates the flow chart, one of the industries most used tools. Additionally, comparisons of a device can now only be made to previously cleared versions of that device. When device changes require the manufacturer to submit a 510(k) for a change, they are to use the previously cleared version of the device for the predicate. Previously, if they were to submit a new 510(k) they could use any cleared device for the predicate. Another change is that the new guidance does not allow limiting the indications for any reason beyond marketing or it will be considered a substantial change. Lastly, the new guidance added a section on manufacturing process change.
Source: Medical Device and Diagnostics Industry
