Regulatory Focus™ > News Articles > FDA Calls for Proposed Industry Labeling Standards

FDA Calls for Proposed Industry Labeling Standards

Posted 29 February 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration is proposing to study how to best standardize medical device labeling by polling healthcare providers and is calling on industry to generate recommended labeling formats and contents.

FDA opened a comment period on the proposed study back in November 2011, and received comments from industry group AdvaMed questioning the utility of the study, the accuracy of the estimated burden, the validity of the methodology and the subject to be polled.

"We agree that industry could provide recommended contents and formats of labeling and encourage industry to do so," said FDA in the Federal Register posting.

"The survey is designed to elicit responses on the formatting, content, and design of the template and not on the specific medical device chosen," said FDA. "The terms used in the templates such as 'warnings', 'contraindications', and 'brand name' are commonly used terms in labeling for all devices. We are addressing what should be in a shortened version of labeling that will allow the user to operate it safely."

Read more:

Agency Information Collection Activities; Proposals, Submissions, and Approvals: Survey of Health Care Providers' Responses to Medical Device Labeling


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