For AI/ML medical application developers, 2019 is the best of the times and the worst of the times.
The best of the times are:
In April of this year, FDA released a proposal, Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML) – Based Software as a Medical Device (SaMD), which proposed a novel regulatory framework for AI-based medical devices. In about the same time, CMS(Center for Medicare & medicaid Services)announced a $1.65 million challenge to develop understandable AI products for healthcare.
The worst of the times are:
As hundreds of comments from manufacturers indicated, FDA’s proposal needed improvement and was in conflict with industry standards that were developed or being developed. Furthermore, some earlier approved computer aided diagnostics were deemed as failure in clinical publications.
And there are already over three hundred proposals were submitted to CMS in few weeks. The selected ones will get 1st phase funding in October, 2019. This demonstrates the competition of AI/ML developers is really heating up.
In the last 30 years, I have provided regulatory submission of various class II and class III medical devices and Drug submission. Most were involved with innovative and ground breaking technologies. My experience of regulatory submission can be highlighted in the following four events:
- I led a multi-functional team with team members located in Netherland, Sweden and USA to obtain a PMA approval of an intraocular lens(a class III device) for Pharmacia(Sweden) in record time*. Pharmacia was merged with Pharmaceutical conglomerates Upjohn and Pfizer.
- I was invited by FDA as a guest speaker in a regulatory conference.
- I have obtained SBIR grant from NIH(National Institute of Health) based on one of my inventions. (1 R43 EY020073-01)
- I converted dozens DMF’s(drug master files) to eCTD(electronic Common Technical Document ) format from original paper submissions and I also completed several new eCTD submissions with proprietary ESG set up that complies with FDA top down requirement. The eCTD submissions were completed with ground up coding due to the unique features of the Drug Master File required by FDA and budget constraint of my clients.
If you are interested in my help in your regulatory service, please contact me via jsc@fdaconsultantnusagent.com or call us at 949 885 8875.