FDA医疗器械收费标准

Table 2Medical Device Fees for FY 2012 Standard Fee, as a Percent of Application fee 七实自 the standard fee fox a premarket application FY 2012 standard fee FY 2012 busines PremarJcet application a PMA ted under section 515 c 1 of x;he FDC Act 21 U.S.C. 360ec 1, a PDF ted under section 515f of the FDC Act, or a 3LA ted under section 351 of the Public Health Service PHS Act 42 U.S.C. 262. Pxemarket report submifced under section 515c2 of the FDC Act. Efficacy 3uppleir.ent to an approved 3LA under section 351 of the PHS Act・ Fanel-track supplement 180-day supplement Real-time supplement 510k premarket notification submission 30-day notice 513g 21 U.S.C. 360c g request for classification ination. Set in statute at 256,32, but offset by multiplying by 85.S281 percent. 100 100 75 15 7 1.34 1.6 1.35 S220f050 220,050 220,050 165,038 33,008 15,404 4r049 3,521 2,971 Annual Fee Type 3.5 Set in statute at 2,364, but offset by multiplying by 35.82S1 percent. 7,702 2,029 Annual fee for periodic reporting on a class III device. Annual establishment registration fee to be paid by each establishment zhaz is a manufacturer, a single-use device reprocesscr, cr a specification developer, as defined by 21 U.S.C. 379113. 工厂年费的付款方法和步骤 VII. Procedures for Paying Annual Establishment Fees In order to pay the annual establishment fee, firms must access the Device Facility User Fee DFUF Web site at . FDA has verified the Web site address, but FDA is not responsible for any subsequent changes to the Web site after this document publishes in the Federal Register. The Web site includes a short interactive questionnaire to help you ascertain whether an annual registration payment is required for your type of facility. If you are required to pay an annual establishment registration fee, you must pay for each establishment prior to registration. You will create a DFUF order and you will be issued a PIN once you place your order. After payment has been processed, you will be issued a payment confirmation number PCN. You will not be able to register your establishment if you do not have a PIN and a PCN. An establishment required to pay an annual establishment registration fee is not legally registered in FY 2012 until it has completed the steps in the paragraphs that follow to register and pay any applicable fee. See 21 U.S.C. 379jf2. Companies that do not manufacture any product other than a licensed biologic are required to register in the Blood Establishment Registration BER system. FDAs Center for Biologies uation and Research CBER will send establishment registration fee invoices annually to these companies. A. Step One a Device Facility User Fee DFUF Order With a PIN From FDA Before Registering or ting Payment To a DFUF order; you must create or have previously created a user account and pass