Author: Michael Dalgleish

FDA Support Mobile Revalidation Protocol

Leading smartphone diagnostics’ specialist, Novarum DX™, has worked alongside several customers to prepare FDA pre-submissions for lateral flow diagnostic applications.This process combines a lateral flow test with a Mobile Medical App (MMA) to read and share the result of diagnostic tests. Whilst each submission and System must be considered on its own merits, there are some recurring themes, that are worth highlighting. Novarum DX™, has developed protocols for managing software updates, hardware changes and future product improvements which address risk and the revalidation process. The FDA has reviewed these protocols, support our approach and we’ve highlighted three findings in this blog:

1. Changes enable medical app providers to respond to both the continually evolving mobile market and to issues such as security vulnerabilities that may arise after market release. Where the performance of a system is dependent on device hardware, the app provider can agree protocols for validating the mobile app on new hardware, as it is released to the market, to ensure equivalence. App providers must therefore engineer risk controls to prevent use on unsuitable hardware, or if a software version has been withdrawn.

2. Submissions for the complete System generally attract much of the focus on the diagnostic test performance and validation protocols themselves, rather than any mobile specific concerns. To this end, they are no more onerous than 510(k) submissions for traditional point of care products.

3. Mobile Medical Applications lend themselves to consumer use in “over the counter” or “at home” situations. The perceived risk with allowing lay users to operate MMAs without clinical supervision, or the benefit of professional experience, is higher. Accordingly, in these situations, the FDA will expect to see evidence of usability studies which show that users are able to effectively operate the system (both the test and the app) without introducing safety or performance concerns. Those studies should include no more training than a typical user will receive, after market launch.

How can Novarum assist with your FDA pre-submission?

Novarum DX™ can assist by:

• – Supporting your regulatory submissions, in particular, guiding you through the software specific requirements, letting you focus on the diagnostic performance and trial protocols
• – Utilising our proven app architecture and established workflows, together with our experienced mobile development team, to reduce the risk that unacceptable issues will be discovered during user trials
• – Supporting your submissions with our agreed risk evaluation and revalidation protocols to enable ongoing product improvement
• – Providing in-built mobile software management so that software versions and hardware compatibility can be remotely managed

If you would like to learn more about our revalidation protocol, our smartphone diagnostic readers, or how we can support your FDA pre-submission, contact Novarum DX™: enquiries@null79.170.44.103