Medical Device Industry And FDA Reach Provisional Fees Agreement

An agreement, in principle, regarding proposed recommendations for the new reauthorization of a medical device user fee program, has been agreed by the FDA and the Medical Device Industry. If the recommendations go through, the FDA would be authorized to collect $595 million from the medical device industry in user fees for a five-year period, with adjustments according to annual inflation rates. The FDA (Food and Drug Administration) says the fee structure will soon be finalized.

The fee program, if finalized in its present form, would have the industry paying fees to help pay for some of the FDA's device review activities, while the Agency would agree to performance goals of reviewing a proportion of applications within set deadlines.

This provisional agreement comes after one year of negotiations between the medical device industry and the FDA. The Agency believes it strikes a well thought out balance between what the FDA can practically accomplish with the available funds, and what the industry agreed to pay. There would be greater predictability, transparency and accountability, resulting from a more structured pre-submission process and earlier and closer liaisons between submitters and the FDA.

The extra money would mean the FDA could employ an additional 200 full-time employees by the end of the five years. Average total review times would be considerably reduced, both the industry and the FDA believe.

FDA Commissioner Margaret A. Hamburg, M.D., said:

"I want to commend my staff and representatives from industry for their tireless work and commitment to achieving an agreement in principle on medical device user fees. Reauthorization of this important program is an essential component for advancing medical device innovation."

The following associations have reached a provisional agreement with the FDA:

• the Advanced Medical Technology Association
• the Medical Device Manufacturers Association
• the Medical Imaging and Technology Alliance

The user fee program was established ten years ago by Congress, when the " Medical Device User Fee and Modernization Act of 2002 (MDUFA I)" was passed. It came about after concerns emerged regarding the capacity and performance of medical device review programs. It was reauthorized in 2007, under the "Medical Device User Fee Act of 2007 (MDUFA II)", which expires at the end of September this year.

Under MDUFA II, the FDA can collect user fees for some medical device submission, when certain medical device establishments want to become registered, and for some other purposes. A waiver is sometimes granted to smaller businesses on some submissions, while other may quality for a lower fee.

Before starting negotiations with regulated industry, the FDA held a public meeting in September 2010 on the device user fee program. Various stakeholders attended the meeting, including those from the industry, experts from academia and scientific centers of excellence, doctors, and patient and consumer advocacy group representatives. The stakeholders gave vital feedback on how the MDUFA program fared overall, which aspects of it should be kept, altered, or dropped, so that the program could be further improved and strengthened.

In a communiqué, the FDA wrote:

"Once the final details of the agreement with industry is completed, FDA will develop a package of proposed recommendations and give the public an opportunity to comment before they are submitted to Congress."

The date of the next public meeting is yet to be announced, the FDA wrote.