FDA submissions, market access by comparison, do it with MatrixALM!
The Regulatory Affairs Professionals Society - "RAPS" - gave very interesting insight in the "FDA Pre-Submission" and "FDA 510(k) Survivor" training into the details of preparing and maintaining FDA submissions for medical devices, including diagnostical devices.
Participants got a lot of tips about what the FDA experts expect and how to meet their expectation.
We learned that Pre-submissions are very nice tool to clarify the regulatory pathway - they cost nothing and give valuable feedback for basic decisions about classification and to decide the methods for testing and validation - decisions which can take a lot of money and should better be right the first time.
To survive a 510(k) submission, there needs to be thorough discussion between the company/product management and the regulatory experts about which marketing claims the product shall have. Depending on this is the intended use for the submission. Basically, the decision is to be either comparable with a device on the market, or prove the device to be completely new. In the latter case, a "de-novo" submission has to be done which is more expensive regarding the costs, and requires a lot more documentation and evaluation than a 510(k) submission. The 510(k) submission will mainly have to prove the equivalence with an existing device - so the effectiveness for the intended use and the safety for the patients and other users are known. That allows to rely on existing clinical data and will mostly not require diving deeply into the technical file or the testing and validation.
A very strongly emphasized tip was to lay out the submission documentation as a story about the product. This will require the RA persons to freely edit and adopt the documents they create for the submission, and to thoughtfully select the information from the product that will go into the submission. Using the new electronic submission eSTAR, the problem of document formatting has been replaced by having to use a pdf template for the main content of the submission.
In our reception, a tool to support the FDA submissions for RA people does not only have to provide document creation and management capabilities, but also needs to be able to handle all the activities and communication regarding the submission. The technical file and verification and validation data need to be very well structured, too, to make their thoughtful use possible. This can only be well achieved with an ALM system which keeps all this information visible and linkable, so that preparation of the submission is not a nightmare of searching the relevant information over and over in emails and files.