PMA vs 510(k) for Mammography Machine

Kuldeep Singh

Involved In Discussions
#1
Hello Everyone!

We are manufacturer of Mammography machine intended to acquire 2D and 3D images of entire breast. As per study , we come to conclusion that we requires two type of submission for this device i.e PMA submission of Digital Breast tomosynthesis (3D Mammography) (Class III) and FDA's 510(k) for 2D Mammography (Class II). Please correct us if we are wrong.

As we're new to PMA submissions , can anyone help us by resolving our queries.
1. If we go with PMA submission first, then is it necessary to submit for 510(k) clearance???
2. What is difference between PMA and 510(k) submission???
 
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chris1price

Trusted Information Resource
#2
The difference between 510(k) and PMA is very significant, in terms of resources, cost and time. Typically a PMA is 10 to 100 times more expensive than a 510(k), and should not be taken lightly. I would strongly recommend hiring a consultant to review your decision to look at a PMA and to guide you through it, and also put a pre-submission request into FDA for confirmation.

Normally you would file a 510(k) first with as many claims/indications as possible, you should get a response in less than 90 days. This will tell you if a PMA is required. The average PMA review time is currently over 240 days.
 

Watchcat

Trusted Information Resource
#3
To put things into quantitative terms, here are the number of original radiology PMAs that FDA has approved in the past 10 years:

2012 - 3, 2013 - 1, 2014 - 1, 2015 - 2, 2016 - 1, 2017 - 2, 2018 - 0, 2019 -0, 2020 - 2021 - 2

It cleared literally tens of thousands of 510(k)s in that same time period. Original PMAs not only require a significant investment of manufacturer time and money; they also require far more FDA reviewer time than a 510(k). That is one reason the standard FY2020 filing fee for a 510(k) is only $12,432 and the PMA filing fee is $345,567. For a Class III mammography device, it usually takes at least 6 months from PMA submission to approval, and a year or more is not unheard of.

Original PMAs are virtually always supported by data from a pivotal trial. The mammography PMAs with which I am familiar included data from more than one clinical study, with a total enrollment of 1,000-2,000 patients.

I routinely do high-level regulatory assessments for companies considering a regulatory path with which they have no prior experience, intended to support a management decision on whether or not to pursue the project. Typical cost is $2,000-$5000, depending in part upon the level and type of detail the company wants for its decision. If you would like to discuss this further, contact me via Elsmar PM or the email address in my profile.
 
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