As seen from a recent inquiry, Senator Charles Grassley doesn't mind holding FDA and manufacturers accountable for any possible unapproved devices (or unapproved uses). Grassley's name has popped up quite a bit in medical device regulatory matters: *He fought against Andrew von Eschenbach being confirmed as FDA's commissioner. *He proposed a bill that, among other things, would give FDA more authority to require postmarket studies and penalize firms that fail to complete them. *He pressed CDRH on looking into Guidant's defibrillator problems. *He asked von Eschenbach to investigate the investors of the start-up company that developed the Prodisc device manufactured by Synthes. *He sent a letter to the Cardiovascular Research Foundation requesting information about its financial relationship with Abbott Laboratories and four other companies.

A penny for Grassley's thoughts on transforming the agency...