Module 12 Presentations

07/02/2024

The Challenge of Artificial Intelligence Compliance

• Static Ais vs Algorithmic Change Protocols • Static AI – an algorithm with parameters that are set at each version • Algorithmic change – an AI with an ever changing algorithm based on additional data • Predetermined Change Control Plans [PCCPs] allow AI/ML-enabled medical devices to be rapidly modified & updated in response to new data. • A risk-based, and evidence-based approach, with a high degree of transparency and consideration to total product lifecycle – but do manufacturers want to provide the FDA with source-code to allow for transparency?

The Organisation for Professionals in Regulatory Affairs

23

The Challenge of Artificial Intelligence Compliance

• The Big Question – can you use an AI programme within your compliance systems and as part of new product registrations? • There is no answer – industry cannot decide • My opinion? • Using an AI programme to monitor parameters and transfer data [without modification] is not different than a standard piece of software • Using AI to generate documentation / text / analysis that is submitted for approval is very high risk

The Organisation for Professionals in Regulatory Affairs

24

12