Michael Burgess actually said...

Substantial equivalence does not necessarily equate clearance, and your own information that you sent to a company that receives a substantial equivalence determination, 'Please be advised the FDA's issuance of a substantial equivalence determination does not mean that the FDA has made a determination that this complies with other requirements of the Act.'

04/17/2012

https://congress.gov...

More Michael Burgess Quotes

"I argue that Government has to get involved, that this is a market failure, and what I need are some good regulations."
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