The ombudsman’s office for the FDA’s medical device arm released details of the contacts it had with the public last year, including complaints about the watchdog agency’s reviews of medical technology.
The Center for Devices & Radiological Health’s ombudsman said there were 461 new contacts in 2011, 11% more than during the prior year. The contacts included questions, requests for clarification, or issues that don’t rise to the level of a complaint or a dispute.
“A complaint is typically an expression of dissatisfaction, perhaps about timeliness, lack of communication, or an unhelpful employee,” according to the FDA. “A dispute usually involves a disagreement with, a challenge to, or an appeal of a decision or action the center has taken or is about to take.”
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Last year the ombudsman’s office began using an electronic record-keeping system to track contacts. The new cases for 2011 broke down this way:
| Type | 2011 | 2010 | 2009 |
| Inquiries | 201 (44%) | 206 (50%) | 65 (26%) |
| Complaints | 202 (44%) | 171 (41%) | 132 (53%) |
| Disputes | 43 (9%) | 26 (6%) | 53 (21%) |
| Other | 15 (3%) | 11 (3%) | n/a |
| Total | 461 | 414 | 250 |
Nearly ⅔ of the inquiries came from industry, according to the ombud’s office, with nearly ¼ coming from consumers:
| Type | 2011 | 2010 | 2009 |
| Industry | 278 (60%) | 269 (65%) | 175 (70%) |
| Consumers | 105 (23%) | 93 (23%) | 42 (17%) |
| Health Care Providers | 33 (7%) | 25 (6%) | 23 (9%) |
| Internal employee* | 23 (5%) | n/a | n/a |
| Other | 22 (5%) | 27 (6%) | 10 (4%) |
| * Beginning in 2011, the Office of the Ombudsman is the central point of contact within CDRH for internal employee inquiries, complaints and differences of opinion not handled by other means. | |||
The agency closed out 487 cases in 2011, including 1 from 2007, 10 from 2009 and 82 from 2010; 3 cases from 2010 are still open and 60 cases remain open from 2011:
| Type | 2011 | 2010 | 2009* |
| Referred to CDRH Subject Matter Expert | 65 (13%) | 86 (24%) | n/a |
| Email response to inquirer | 150 (31%) | 83 (24%) | n/a |
| Teleconference | 38 (8%) | 48 (14%) | n/a |
| Referred to OCER (DSMICA) | 41 (8%) | 34 (10%) | n/a |
| Closed for inactivity | 58 (12%) | 27 (8%) | n/a |
| Closed with letter | 51 (10%) | 13 (4%) | n/a |
| No action requested or required | 11 (2%) | 13 (4%) | n/a |
| Referred to FDA Ombudsman | 16 (3%) | 10 (3%) | n/a |
| External meeting with inquirer | 12 (2%) | 8 (2%) | n/a |
| Referred to another Center within FDA | 21 (4%) | 7 (2%) | n/a |
| Referred to another Agency | 7 (1%) | 7 (2%) | n/a |
| Internal meeting | 8 (2%) | 2 (1%) | n/a |
| Other | 9 (2%) | 14 (4%) | n/a |
| * Closure type was not tracked in 2009 | |||
