The attempt by the U.S. FDA to harmonize its Quality System Regulation (QSR) with ISO 13485 promises to be a difficult slog, but Jeff Shuren, director of the agency’s device center, said the agency is flexible on the proposed one-year implementation deadline. However, Shuren also noted that the draft rule would not be converted into a final rule at any point during the current calendar year, leaving device makers with an extended term of uncertainty.