Bradley Merrill Thompson Quoted in “FDA Offers Tech Companies Scant Help in Device Guidance”Bloomberg BNA Medical Devices Law & Industry Report December 30, 2016
Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Bloomberg BNA Medical Devices Law & Industry Report, in “FDA Offers Tech Companies Scant Help in Device Guidance,” by Alex Ruoff.
Following is an excerpt:
The guidance also paid little attention to provisions of the 21st Century Cures Act, signed into law Dec. 13, health-care attorney Bradley Merrill Thompson, with Epstein Becker & Green P.C., in Washington, D.C., told Bloomberg BNA in an email. The law required the FDA to classify all device accessories based on intended uses rather than the classification of parent devices. While the guidance mentioned the Cures law, Thompson said the document was issued so shortly after the passage of the law that the FDA wouldn't have had time to complete a review of it.