FDA regulation of press releases, SEC filings as device labeling questioned by HIMA.
This article was originally published in The Gray Sheet
Executive Summary
REGULATION OF PRESS RELEASES, SEC FILINGS AS DEVICE LABELING QUESTIONED by Marlene Tandy, director of the Health Industry Manufacturers Association's technology and regulatory affairs division, at a Sept. 19 session of the Regulatory Affairs Professionals Society conference in Washington D.C. "I just can't see that press releases and Securities and Exchange Commission material have any business being regulated as labeling or advertising," Tandy said.