Regulatory Focus™ > News Articles > Meta Complaints: FDA Says Complaints to CDRH Lack Common Structure, New Standard Needed

Meta Complaints: FDA Says Complaints to CDRH Lack Common Structure, New Standard Needed

Posted 03 May 2013 | By

The US Food and Drug Administration (FDA) is preparing to overhaul the way it receives concerns and complaints about the way in which it regulates and approves medical devices, saying the complaint process could benefit from standardization.


At FDA, medical devices are mostly regulated by the Center for Devices and Radiological Health (CDRH). While many companies get through CDRH's regulatory reviews without any trouble, more than a few have complaints about the process, which are often sent to the center's ombudsman. A recent report issued by the ombudsman's office indicates that it received 224 complaints in 2012, spanning a wide range of reasons.

The agency also receives complaints in other ways, including through its formal dispute resolution system, for which it last released a standard operating procedure in September 2012. Under that SOP, receivers are expected to exhaust normal channels of communication before initiating a dispute resolution process, and are expected to maintain, "An atmosphere of openness, trust, professionalism and mutual respect." The agency said nothing in its policies should be construed as hampering whistleblowers, however.

The SOP also establishes a step-wise approach for dispute resolution, starting with the next highest management official in the CDRH chain of command. CDRH officials must fill out a form of initiation, which is then given to the CDRH ombudsman for evaluation within 10 days. If it is deemed to be worthy of consideration, it is then passed on to the next highest management official in the chain of command, who will re-evaluate the application. This process may continue if the original decision is overturned, and another official believes it was reversed in error. 

And as reported in April 2013 by Jeffery Shapiro and Jennifer Newberger of Hyman Phelps & McNamara, CDRH is also preparing an update to its appeals guidance to make sure it is consistent with the requirements of the FDA Safety and Innovation Act (FDASIA), Section 603 of which called for an expedited review process for "significant decisions."

A Complaint about Complaints

But all of these issues ignore something of a central problem: FDA can't do much about a complaint or appeal if it doesn't have enough information to determine what the problem is.

As FDA explains in its Federal Register posting on 3 May 2013, there are "no established guidelines or instructions on how to submit a complaint to CDRH," leaving the center to take in complaints in every manner short of carrier pigeon and pony express.

And while emails, phone calls and word-of-mouth conversations with staff might be useful in some respects, FDA said it is seeking to "establish a consistent format and process for the submission of device complaints that will enhance our timeliness in receiving, assessing and evaluating voluntary complaints."

The center estimates that it will receive around 700 complaints per year through its various outlets, with each complaint taking an average of 15 minutes to compose. Industry is encouraged to comment on the proposed reporting vehicle-most likely a standardized form-by contacting the agency. Contact information may be found in the Federal Register posting.

Federal Register Posting.

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