President Obama released the Administration’s Fiscal Year 2010 budget proposal this week. The budget request for the Food and Drug Administration totals $2.35 billion, nearly $300 million more than in FY 2009. This figure, however, does not account for the additional revenue generated by user fees of the industries the Agency regulates. Including all user fees, President Obama’s total budget request for FDA is $3.2 billion.
MDMA is reviewing the...
Contact: Erin Jones
Director, Marketing and Programs
(202) 354-7172
WASHINGTON, D.C., April 14, 2009 – Medical device industry leaders, lawmakers, and government officials will gather for the 2009 Annual Meeting of the Medical Device Manufacturers Association (MDMA) June 1st – 3rd at the Park Hyatt in Washington, D.C.
The MDMA Annual Meeting will bring together executives from innovative entrepreneurial medical...
FDA published an Order in the Federal Register requiring manufacturers of twenty-five (25) Class III pre-amendment devices to submit to FDA a summary of, and citation to, any known, or otherwise available, safety or efficacy information, including that information which has not been submitted under section 519 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360i). See (74 FR 16214). The twenty-five (25) devices identified are those Class III pre-amendment devices for which a...
President Obama announced the nomination of Dr. Margaret Hamburg to be the Commissioner of the Food and Drug Administration. Dr. Hamburg has held a number of positions within the Federal government including serving as Assistant Director of the National Institute of Allergy and Infectious Diseases of the National Institutes of Health as well as serving as the Assistant Secretary for Planning and Evaluation, U.S. Department of Health and Human Services. Dr. Hamburg will undergo the Senate...
The Government Accountability Office (GAO) published a report on FDA’s 510(k) review process. The report validates the current 510(k) review process. However, the GAO recommended that FDA review the small number of Class III products currently using the 510(k) premarket review pathway and either reclassify the products or require them to be reviewed via the PMA process. MDMA agrees that this is the appropriate approach versus modifying the underlying 510(k) process.
The Food and Drug Administration (FDA) opened its first international office in China in November. The opening of the office comes in light of increased scrutiny of the overseas inspection process conducted by the FDA. The China office is the first of several planned international offices to station permanent food, drug and device inspectors.
The Food and Drug Administration recently released a final rule regarding the parameters in which a device manufacturer can modify label changes to a product. Specifically, manufacturers can add or strengthen the contraindications, warnings, precautions or adverse reactions sections of labeling via a PMA supplement without prior FDA approval only when such modifications are based on newly acquired information and evidence of a causal association between the product and a safety signal is...
The President signed the Food and Drug Administration Amendments of 2007 into law earlier this week, only a few days before the current law was set to expire. Congress overwhelmingly passed the measure which will reauthorize the user-fee program for pharmaceutical and device manufacturers as well as provide new regulatory authority to the FDA. With passage of the legislation, the FDA will collect approximately $287 million from device manufacturers over a...
Thomas Gross, the Director of the FDA Centers for Device and Radiological Health, Division of Postmarket Surveillance announced that the new FDA postmarket surveillance system, the Sentinel Initiative will not place additional regulatory burdens upon the device industry. The Sentinel Initiative stems from the Food and Drug Administration Amendments Act of 2007 and would allow for greater collaboration between the FDA and CMS to monitor post-market adverse...
