The problem is that although regulation may be necessary, the regulators incentives are different than the users. Regulators are rewarded for being overly conservative. If they are making an assessment best on the riskiness of a device versus the benefits to its users, they should say what their criteria are.

Different users are willing to accept different amounts of risk for a given quality of life improvement. Besides differing between users, the tradeoff is almost certainly in favor of accepting more risk than a regulator would approve.