FDA's Plans with regard to Medical Devices in 2017
Register now for ECA's GMP Newsletter
What is the FDA planning with regard to the regulation of medical devices? The answer can be found in a report on Regulatory Science Priorities.
Since 2015, the FDA has been publishing its objectives for the following year with regard to the scientific consideration concerning the regulation of medical devices. The objective of those Regulatory Science Priorities - as a "catalyst" - is to enhance the safety, effectiveness, performance and quality of medical devices and radiation-emitting products. The priorities are subject to regular updates.
Here is a summary of the 2017 objectives:
Effective use of Big Data (e.g. from clinical studies) which are intended for regulatory decision-making
Modernisation of biocompatibility and biological risk evaluation of medical devices
Simplification of the evaluations of the different domains in regulatory decision-making
Improvement of tests and methods for predicting and monitoring medical devices in their clinical performance
Development of methods and tools to improve and optimise clinical trial design
Development of computational modelling to support regulatory decision-making
Advancement of the performance of Digital Health and valorisation of medical device cybersecurity
Reduction of healthcare associated infections by better understanding the effectiveness of antimicrobials, sterilization and reprocessing of medical devices
Collection and use of patient information in regulatory decision-making
Efficient use of biomarkers for predicting medical device performance, disease diagnosis and progression
All the details of the programme 2017 are described in a 13-page brochure in which you can also find the differences to the 2016 programme.