FDA Increases Fees for Medical Device Firms

The U.S. Food and Drug Administration is increasing user fees for medical device companies, according to the Federal Register.

The so-called standard fee, the fee by which most payments are determined, has increased to $217,787 for the 2010 fiscal year (from Oct. 1, 2009 to Sept. 30, 2010).

Additionally, an establishment must pay the registration fee of $2,008 for FY 2010 if it is any of the following types of establishments, according to the FDA:

• Manufacturer: An establishment that makes devices, including an establishment that sterilizes or otherwise makes such article for or on behalf of a specification developer or any other person.

• Single-Use Device Reprocessor: An establishment that performs additional processing and manufacturing operations on a single-use device that has previously been used on a patient.

• Specification Developer: An establishment that develops specifications for a device that is distributed under the establishment’s name but which performs no manufacturing, including an establishment that, in addition to developing specifications, also arranges for the manufacturing of devices labeled with another establishment’s name by a contract manufacturer.

Under the act, all submission fees and the periodic reporting fee are set as a percent of the standard (full) fee for a premarket application, and the act sets the standard fee for a premarket application, including a BLA, a premarket report, and an efficacy supplement, at $217,787 for FY 2010.

The fees set by reference to the base fee are:

• For a panel-track supplement, 75 percent of the base fee

• For a 180-day supplement, 15 percent of the base fee

• For a real-time supplement, 7 percent of the base fee

• For a 30-day notice, 1.6 percent of the base fee

• For a 510(k) premarket notification, 1.84 percent of the base fee

• For a 513(g) request for classification information, 1.35 percent of the base fee

• For an annual fee for periodic reporting concerning a Class III device,3.5 percent of the base fee.

For all submissions other than a 510(k) premarket notification, a 30-daynotice and a 513(g) request for classification information, the smallbusiness fee is 25 percent of the standard fee.

For a 510(k) premarket notification submission, a 30-day notice and a 513(g) request for classification information, the small business fee is 50 percent of the standard fee.

The statute authorizes increases in the annual establishment fee for FY 2010 and subsequent years if the estimated number of establishments submitting fees for FY 2009 is fewer than 12,250.