Fluoroscope Regulation Word Change Will Not Affect Manufacturers

April 17, 2015

Changing one word in an FDA regulation affecting fluoroscope equipment will have no effect on devicemakers, a trade group official says.

On Monday, FDA published a direct final rule amending its 13-year-old standard for fluoroscope equipment by changing “any linear dimension” to “every linear dimension.” The FDA also used “any linear dimension” in another rule in the original standard which could have caused confusion. The language is not changed in this section.

Thad Flood, industry director for the Medical Imaging & Technology Alliance, confirmed that the change clears up a potential language issue.

The FDA also published a companion proposal to provide a framework to finalize a new rule. Public comment will be accepted through June 29. Read the proposal at www.fdanews.com/04-14-15-Proposal.pdf. Read the rule at www.fdanews.com/04-14-15-Rule.pdf. — Charlotte Astor