The MDUFA stands for Medical Device User Fee and Modernization Act. This term is quite self-explanatory. It means the fee the FDA collects from medical device manufacturers to review medical devices and drugs before they get approved to enter the market.
For medical devices, the FDA has made three classes -Class I, Class II and Class III. Class I devices are those that don't need FDA approval; Class II devices need premarket notification and Class III devices need premarket approval.
Why charge fees?
Now, we have put this question into perspective. A common query that arises in relation to this is that when classes of medical devices that need FDA approval are sent to the FDA for approval, where is the need for the FDA to collect fees for doing its stated objective and duty?
The answer to this question lies in the definition of the term itself -Medical Device User Fee and Modernization Act. As this expansion illustrates, the FDA collects fees both for approval and modernization from medical device and drug makers. It collects fees from medical device and drug manufacturers -varying according to the complexity of the product for which approval is sought -as a means to sustain itself and develop programs for its and the industry's well-being.
Rates of user fees
The FDA's charges range between a little over $22,000 for a large manufacturer and $55,000 for a company whose gross receipts are under $30 million. As for 510 (K) submissions for a low-risk medical device, the fee is from just over $2,000 for a small manufacturer to a fraction above $4,000 for a large manufacturer.
Period for approval
Nine-tenths of the submissions are cleared in three months or less. It is for complex devices that more time is usually taken.
Budget allocation and spending
The FDA usually allots budgets under the MDUFA for periods of five years. Its allocated budget is at between $500 million and $600 million for every five years. The main source by which this money is spent is on preparing vital guidance documents. These documents are meant to make the approval process of complex drugs and devices easier. Hence, this is more of a development program budget for the FDA, which uses these funds for the eventual good of the industry and the public.
Industry support and expectations
In this budget, only about a fifth comes from the FDA. The rest is from the drugs and devices industry. These industries sponsor this approval process in return for lesser hassles in approval of their products. The industry also expects the FDA to be more translucent and less bureaucratic in its approval process. It would also want the process to be more predictable, which will help industry players to stick to set processes that make approvals easier and faster. Other expectations from the industry include more streamlined FDA guidance about the approval process, training and professional development for the person or organization that has applied for the review, more reporting on the performance of the program, more interactions that facilitate smoother working between the agency and the organization, and so on.