5 MYTHS ABOUT PMAs

This is an extra resource to go along with the original article:

How FDA Distinguishes Between Clearance vs. Approval vs. Granted

Here are some common PMA myths, along with the reality of what’s really true:

1. Myth: PMAs are only for invasive devices.

Reality: No, not necessarily as a non-invasive device may still be classified as high risk.
An example of a non-invasive Class III device is the IVD for cancer diagnosis. The
machine isn’t even in the same room as the patient, but the risk is associated with false
negatives or false positives.

2. Myth: Substantial equivalence can never be used with PMAs.

Reality: While that’s true from a regulatory perspective, there are ways to examine what
other companies have done before and use that. Testing is an example - you could say
your device is “similar” (but not substantially equivalent) to another and use their testing
matrix as a starting point for your own.

3. Myth: All PMAs require clinical data.

Reality: While the majority of PMAs require clinical data, no matter which regulatory
pathway you take, the question of clinical testing should come down to how well
established the technology is, the pathophysiology and the risks. If you couldn’t get new
information from clinical data, you have a case to push back against requiring it.

4. Myth: If you have a choice, always go with a 510(k) submission over PMA.
Reality: The thought process behind this is generally a notion that 510(k) will be easier,
which can be a myth in itself. While the PMA may be a little more involved, it can also be
an easier sell to the FDA than trying to sell them on a Class II 510(k). Additionally, taking
the PMA route makes it harder for your competition to follow in your footsteps. (Think
“competitive regulatory strategy”)

5. Myth: Startups should opt for 510(k) because PMA fees are so expensive.
Reality: PMA fees are a lot more expensive than 510(k) fees, however, there financial
assistance programs available, including one that offers startups their first PMA free as an
incentive to use that pathway. It may make sense as part of your competitive regulatory
strategy.

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