There have been a number of interesting lab industry policy articles originating from, or associated with, MGH in the last few months. See an article on the costs of implementing VALID Act, Huang et al., here. See an article on FDA, regulatory innovation, COVID regulation, and insights for the NEXT era of FDA lab regulation, Marble et al., here.
Add a third one. This one is on the interface and interaction between regulatory affairs, reimbursement, and product life cycle management -- with a focus on the rapidly progressing digital pathology industry.
Find Kearney et al, "Bridging the Gap: The Critical Role of Regulatory Affairs and Clinical Affairs in the Total Product Life Cycle of Pathology Imaging Devices and Software," open access, here.
By the way, their Figure 2, showing "regular LDT" and "FDA approved LDT at one site" and "IVD" is a nice one:
|Kearney 2021 Fig 2|
Below the break: Abstract and first paragraph.