PMA Approvals for Medical Devices and Diagnostics


The Devices and Diagnostics edition of the PharmSource Lead Sheet focuses on high risk devices that require Premarket Approval (PMA) from the US FDA. If we take a look at data extracted from the FDA’s database and the PharmSource Lead Sheet database, we can observe PMA approval trends over time. As shown in Figure 1, the number of original PMA approvals increased from 2013 to 2015. The sharp increase in PMA approvals in 2015 could have been related to the regulatory conditions at the time (A Closer Look at Medical Devices Approved in 2015). However, in 2016 there is a small decline in the total number of PMA approvals, compared to 2015.

Figure 1

In Figure 2 below, the graph represents the number of original PMA approvals for the first four months of each year from 2013 to 2017. The PMA approval trend for the first four months of the years 2013 to 2015 corresponds directly with overall data for the full year, as shown in Figure 1. It is interesting to note that the number of PMA approvals remained constant from January to April for 2015, 2016 and 2017. Based on the data shown in Figure 1 and 2, it would be hard to predict if there will be an increase in PMA approvals in 2017, compared to previous years.

Figure 2

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Judy Nanthavong is a Senior Research Analyst at PharmSource, and specializes in covering events related to medical devices and diagnostics. Prior to joining the company as a full-time, permanent staff member, she previously worked here as a student intern. Judy holds a BS degree in Health Science, Health Systems Management from George Mason University.

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