Medical device user fees to increase 68% for 2018 to 2022
pharmafile | August 25, 2016 | News story | Research and Development, Sales and Marketing | FDA, Medical device
The Food and Drug Administration has reached an agreement with the medical device industry and laboratory community on proposed recommendations for the fourth reauthorisation of a medical device user fee programme. Under this new agreement, the FDA is authorised to collect $999.5 million in user fees plus inflation over five years, a 68% increase from the $595 million in 2012.
The deal also sets lower time goals for reviewing 510,000 premarket notifications and premarket approval applications and would require the agency to provide feedback to companies at least five days before presubmission meetings are held. It additionally requires two independent analyses of the FDA’s handling of review process in order to increase accountability. Furthermore, the FDA is expected to bundle all of its user fee programmes into a single legislative package.
The Advanced Medical Technology Association, Medical Device Manufacturers Association and Medical Imagin & Technology Alliance have all voiced their support of the deal, claiming it will enable the FDA to hire additional reviewers and improve its IT and infrastructure.
According to Jeffrey Shuren, director of the Center for Devices and Radiological Health, the agreement “reflects the efforts the FDA has made to meet or exceed its performance goals and to help speed patient access to safe and effective medical devices.”
Final recommendations on the fees are due to be reviewed by congress in January.
Matt Fellows
Related Content
MRM Health’s ulcerative colitis treatment receives FDA Investigational New Drug clearance
Microbial Resource Management (MRM) Health has announced that its lead programme, MH002, has received Investigational …
Complement Therapeutics’ geographic atrophy treatment receives FDA Fast Track designation
Complement Therapeutics has announced that CTx001, its gene therapy treatment for geographic atrophy (GA) secondary …
Johnson & Johnson submits robotic surgical system for De Novo classification
Johnson & Johnson has announced the submission of its Ottava Robotic Surgical System for De …
