20 20; ABC; AMBU INTL; BIRTCHER MEDICAL; FDA, FOOD AND DRUG ADMINISTRATION; GYNOPHARMA; HHS, DEPT OF HEALTH AND HUMAN SERVICES; HOUSE; JOURNAL OF THE AMERICAN MEDICAL ASSN; OFFICE FOR THE PROTECTION FROM RESEARC R; OFFICE OF DEVICE EVALUATION; OFFICE OF DRUG EVALUATION I; PLEXUX INTL; SMALL BUSINESS REGULATION SUBCOMM; UNIV OF MN MINNEAPOLIS