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Uhhh... that's not correct at all.[1]

Are you confusing it with post-marketing commitments to run additional clinical trials? That's not the same thing as post-marketing surveillance.

[1]http://www.fiercepharma.com/story/roche-overlooks-80000-adve...

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"Not all Phase IV studies are post-marketing surveillance (PMS) studies but every PMS study is a phase IV study."

"Under the current system, the FDA has the authority to revoke approval of some drugs for which Phase IV commitments have not been honored. This authority has never been invoked."

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3148611/

http://www.citizen.org/hrg1520

The Phases apply to drugs, not devices.

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