The FDA regulates implantable medical devices, digital therapeutics, and diagnostic tests through the same broad pathways: PMA, 510(k), and De Novo. Yet each of these product types presents
writing report
Attached instruction and readings, need 400 words, please no plagiarism.
Requirements: 400 words
Write a Reflection Paper for this week?s learning, in 400+ words.
You need to write two parts,
Part 1 – Key points from this week?s Reading (I have attached the readings here?:
Readings:
C Johnson et al. Interstates and Autobahns: Global Medtech Innovation and Regulation in the Digital Age. BCG and UCLA BioDesign Program. March 2022. https://web-assets.bcg.com/8c/f0/06744e8848ea9654bbd0765bf285/bcg-interstates-and-autobahns-mar-2022.pdf
RF Redberg, SS Dhruva. Moving from Substantial Equivalence to Substantial Improvement for 510(k) Devices. New England Journal of Medicine 2019; 322(10):927-928. https://jamanetwork.com/journals/jama/article-abstract/2744408
L Richardson. What are In Vitro Diagnostic Tests, and How are they Regulated. PEW Trusts. Issue Brief. May 14, 2019. https://www.pewtrusts.org/en/research-and-analysis/issue-briefs/2019/05/what-are-in-vitro-diagnostic-tests-and-how-are-they-regulated
While you write key pints, kindly cover the lectures, etc.
Part 2 – Remaining Questions (To expand from the course covered lectures).
Here?s what we have covered this week:
6. Regulation of Devices, Digital Therapeutics, & Diagnostics (March 6)
The FDA regulates implantable medical devices, digital therapeutics, and diagnostic tests through the same broad pathways: PMA, 510(k), and De Novo. Yet each of these product types presents unique challenges in term of ensuring safety, measuring efficacy through clinical trials, and monitoring effectiveness in real world uses. The FDA is seeking to move from a traditional ?gatekeeper? focus on premarket review to a more collaborative and ?life cycle? approach. Similarly, Medicare and private insurers are exploring criteria for coverage and payment. This session will examine some of the special characteristics of these products and consider alternative regulatory approaches that best balance consumer protection with incentives for innovation.
Recorded lectures:
FDA Regulation of Medical Devices
FDA Regulation of Digital Therapeutics
FDA Regulation of Diagnostic Tests
Class activity:
The class will divide into three breakout groups to discuss FDA authorization of medical devices, digital therapeutics (DTx), and diagnostics, respectively. Groups will discuss the special features of their class of technology that influences how FDA does and should approach it and the existing FDA strategy and pathways. Most importantly, each group will suggest modifications or completely new approaches that would better balance the dual goals of consumer protection and support for innovation.
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