CDRH Ombudsman Justifies Existence in Annual Report

The newest annual report from the CDRH ombudsman says the office received 493 new contacts in 2012, up 7% from the 461 in 2011. It breaks these down to 217 inquiries, 224 complaints, 41 disputes, and 11 other contacts. It says the percentage in each category has remained relatively constant since 2010.

The two leading categories of such contacts were adverse event/MDR/safety issue (25%) and 510(k) submission (21%).
A total of 504 cases were closed in 2012, the report says, including all open cases from before 1/1/12. There are 50 open cases remaining from 2012.

The report also says that the Medical Devices Dispute Resolution Panel did not meet in calendar year 2012. A petition was submitted to FDA about a PMA that may result in a panel meeting during this calendar year.

Finally, the FDA Safety and Innovation Act modified the procedures for appeals of significant decisions rendered by CDRH, including timeframes for submissions and responses. Between January 9, 2012 when the law was enacted, and last December, CDRH received 10 appeals of significant decisions, three at the Center level and seven at the Office level. All three Center-level appeals and four of the seven Office-level appeals received a final decision, all within statutory time frames, the report says. Three Office-level appeals were received near the end of the year and remain under review.

If you are still awake, you might be wondering, "well so what?" Such bland, introspective statistics seem to be a waste of time, justified only by an obscure accountability requirement that the ombudsman annually account for his existence.

At best, the ombudsman provides a listening opportunity when a company has a problem, but, as has been demonstrated in the latest Class III imbroglio, his ability to solve a problem isn’t assured. All that has to result is a “final decision.” As to what those final decisions might be? The annual reports never say.

If a company has a grievance the ombudsman does not resolve (he has no authority to impose any result on his own agency), there are limited options.

In one notorious case, the ombudsman-shunned TMJ Implants demonstrated that an option might be to appeal to Congress, the courts, or the media. This likely would arouse CDRH resentment, however, and according to industry lore, imperil the company’s future interactions with the center.

Until the FDA Press Office began injecting itself into all media communications with employees, I knew and dealt with many FDA ombudspersons and always found them sincere and diligent. However, none could recount success stories where they had done any good.

Their terms of appointment disallow individual case publicity, even anonymized, so we are left with the uninformative self-adjudicated accountability of the annual reports.

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