FDA CDRH ombudsman releases 2011 report

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The FDA’s Center for Devices and Radiological Health (CDRH) has released its ombudsman report for 2011, the first year the office’s electronic tracking system has been used to facilitate record-keeping and trending.

The data show a total of 461 new contacts for the year, up from 414 in 2010 and 250 in 2009.

The ombudsman’s office fielded 201 inquiries, 202 complaints, 43 disputes and 15 uncategorized contacts in 2011. Some 278 of the contacts were initiated by industry, with the balance coming from consumers (105), healthcare providers (33), CDRH employees (23) and other individuals (22).

As for reasons stakeholders reached out to the CDRH ombudsman in 2011, the report shows contact counts as follows:

  • 151 Policies and Procedures;
  • 111 Miscommunication/Lack of Communication;
  • 29 Practice of Medicine;
  • 27 Data/Testing Requirements;
  • 26 510(k) Not Substantially Equivalent;
  • 21 510(k) Request for Additional Information;
  • 16 Level Playing Field;
  • 14 Registration and Listing;
  • 13 PMA Not Approvable;
  • 6 Complaints about CDRH Employee; and
  • 47 Other.

Also included in the CDRH report are data showing which CDRH offices were contacted and how frequently in 2011; what sorts of inquiries, complaints and disputes were filed; and the year-end status of inquiries, complaints and disputes. The report also presents comparative data from 2009 and 2010.

CDRH’s current ombudsman is David S. Buckles, PhD, a former cardiology researcher and industry CTO.

Elsewhere on its website, FDA points out that the CDRH ombudsman investigates complaints from outside FDA and facilitates the resolution of disputes between CDRH and the industry it regulates. “The CDRH ombudsman is a good starting point if you have a complaint, question or dispute of a scientific, regulatory or procedural nature,” reads a statement on the site. “He can answer questions, follow up on a complaint, discuss appeal and dispute resolution options or mediate a dispute. While providing this assistance, he maintains his impartiality and neutrality. The ombudsman advises the center director, to whom he reports, on ways to assure that our procedures, policies and decisions are of the highest quality and are fair and equitable.”