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Did you know the market for precision medicine is projected to more than triple by 2026? I’m not surprised by the growth rate given everything we’re reading about personalized medicine. So I got to thinking: How would you regulate something like that?
Taken to extremes, if every device were customized to every single patient, how could the clearance for use be comprehensive enough?
How will you position yourself to ride this wave? This piece is a good thought starter: “Companion Diagnostics, Biomarkers, and Novel Innovations for Oncology and Beyond.”
You know this isn’t my personal area of expertise so you may want to download it. I pulled some of these lines for you:
For more information, download the paper, a courtesy of our friends at ICON, plc.
FDA webinar in two days.
Click here for the FDA content, courtesy of Jon Speer and Greenlight Guru.
And you’ll get access to the first FDA in the series where they covered what CfQ is and how FDA is engaging; summary detail on CDRH pilot programs; and, how FDA is rethinking regulations.
Members with questions
If you’ve got the answers, please share with our community.
Tautvydas Kazlauskas has a question on how to classify a fibrin-glue like medical device.
Antonia Trevisan asks, “Are custom-made devices exempt from CE marking?”
And I could really use help on Irina’s question. So far no one has answered, “How to estimate safety BSE requirements?”
A whole new world
As you can see, with our new home here in WordPress, I can add images and video each week. But even better, I have enough room to express myself and to highlight questions and contributions from group members like you!
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Make it a great week.
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Well… this so-called “precision medicine” is already here and has been, to some degree, for many years. I suspect that most products will be treated as class three requiring a PMA-style review and approval although I can see where some might be down classified through de novo. The difference is that we are talking about a PROCESS as opposed to some piece of hardware or other physical thing (like a drug, for example). In the end it will all come down to a proper risk-management analysis where you have to 1) identify all possible hazards, evaluate their risks and reduce those risks to an acceptable level and 2) be able to demonstrate to the regulator that you did a complete and accurate review and that the resulting product (whether device, drug or process) is safe and effective.
The regulatory process is not just some rote checklist or form. Rather it is a requirement on the manufacturer to ensure that their products are safe and effective. I don’t see anything in the existing regulatory process that would not be adequate for precision medicine. And if they don’t already exist, expect the regulatory agencies (like the FDA) to publish guidance documents for how such precision medicine devices/processes will be reviewed and approved.
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