FDA Is Suffocating the Small Businesses It Should Be Helping (Jim Dickinson @ MDDI)
Some companies can’t afford CDRH’s inconsistent and capricious approach.
For as long as I can remember, CDRH has done a poor job of helping small businesses work through the choking thicket of agency regulations. Despite statutory directives to do better, the center is failing these companies, though small firms are widely regarded as major drivers of the U.S. economy.
Certainly, the center’s Division of Small Manufacturer Assistance has helped hundreds of companies. But it too often gets bogged down in regulatory warfare with small firms whose products and leadership don’t fit into a tidy bureaucratic box. Neither the division nor the agency’s ombudsman’s office has been of much help in those cases.
That is a problem. Large companies have the resources to deal with and survive a maze of regulations; small companies often do not. Jeffrey Immelt, chairman and CEO of General Electric, is the chairman of President Obama’s council on jobs and competitiveness. Speaking on Fareed Zakaria’s television show GPS in September, Immelt said small businesses “have all the problems GE has, only on stero...
