1a1ab05e-b7a0-4804-94e3-69c2149db42e 5
6c5790bd-96de-482c-ab7a-0e77b807d1b6 9

FDA注册咨询,FDA注册产品列明快速办理中心,FDA认证510(K)相关费用说明

来源:本站 作者:深圳市肯达信企业管理顾问有限公司 陈小姐 18575592846 发布时间:2020-07-31

Overview

Federal law authorizes FDA to charge a fee for medical device product review. These fees apply to Premarket Notifications (510(k)s), Premarket Approval Applications (PMAs), Product Development Protocols (PDPs),  Premarket Reports (PMRs), Panel-Track Supplements, Efficacy Supplements, 180-day Supplements, Real-Time Supplements, 30-Day Notices/135-Day Supplements, Biologics Licensing Applications (BLAs for certain medical devices reviewed by FDA's Center for Biologics Evaluation and Research), and Requests for Information (513(g)s). Effective October 1, 2017, FDA will require user fees to support De Novo requests. The appropriate device user fee must be paid for the above listed applications in order for FDA to begin its review, unless the applicant is eligible for a waiver or exemption.

Back to Top Arrow


Fees

Information on user fees is located on the MDUFA user fee page. The applicable fee corresponds with the date the FDA received the submission. Please note that the FDA will consider the submission incomplete and will not begin the review until the fee is paid in full. The FDA will announce the new fees for the next fiscal year in a Federal Register notice prior to the start of each fiscal year. Small businesses may qualify for a reduced fee. A small business is defined as a business (including affiliates) that reported $100 million or less of gross receipts or sales in its most recent federal income taxable year. The small business fee is 50 percent of the standard fee.

513(g)

Guidance on assessing user fees can be found in "Guidance for Industry and Food and Drug Administration Staff - User Fees for 513(g) Requests for Information."

De Novo

Guidance on assessing user fees for De Novo requests can be found in "User Fees and Refunds for De Novo Classification Requests - Guidance for Industry and Food and Drug Administration Staff."2

510(k)

Guidance on assessing user fees for 510(k) submissions can be found in "Guidance for Industry and FDA Staff: Bundling Multiple Devices or Multiple Indications in a Single Submission."

PMA & BLA

Guidance on assessing user fees can be found in "User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications - Guidance for Industry and Food and Drug Administration Staff."

Back to Top Arrow


Exemptions and Waivers

The following exemptions or waivers apply for the user fees for Medical Devices regulated by submissions:

Category510(k)PMA, PDP, BLA or Premarket Report (PMR)513(g)De Novo
First application submission fee waiverNo waiverOne-time first submission fee waiver for a small business with gross receipts of sales <$30>No WaiverNo Waiver
Any application from a State or Federal Government entityExempt from any fee unless the device is to be distributed commerciallyExempt from any fee unless the device is to be distributed commerciallyNo WaiverExempt from any fee unless the device is to be distributed commercially
Any application for a device intended solely for pediatric useExempt from user fee.
Note: changing the intended use from pediatric to adult requires  the submission of a new 510(k) and is subject to user fees
Exempt from user fee
Note: if the applicant obtains an exemption under this provision, and later submits a supplement for an adult use, that submission is subject to the fee in effect for an original PMA
No WaiverExempt from user fee
Third- party reviewExempt from FDA user fee.
Note: the third-party charges a fee for its review
Not eligibleNot eligibleNot eligible
BLA for product licensed for further manufacturing use onlyN/AExempt from User feeN/AN/A

Back to Top Arrow


When to Pay

Payment must be received and processed at the time or before the date the application is sent. If the FDA receives an application without full payment of all required fees, the FDA will consider the application incomplete and will not begin its review.

Back to Top Arrow


How to Prepare Payment

  1. Determine the correct user fee that is required for the type of submission.
    Note: If the applicant qualifies as a small business, follow the instructions in the Guidance for Medical Device User Fee Small Business Qualification and Certification. Applicants that qualify will receive a Small Business Decision number. The Small Business Decision number must be provided on the Medical Device User Fee Cover Sheet at the time of submission to be eligible for reduced fees. The FDA will not accept reduced fees without a Small Business Decision number and will not refund the difference between the standard fee and the small business fee after the submission has been received.

  2. Determine if a Medical Device User Fee Cover Sheet is required.  Please see table below.

    Application TypeType of SubmissionUser FeeUser fee coversheet
    required (FDA Form 3601)
    513(g)OriginalYesYes
    De NovoOriginalYesYes
    510(k)TraditionalYesYes
    SpecialYesYes
    AbbreviatedYesYes
    Third Party ReviewNoNo
    Any submission that meets the criteria for an exemptionNoYes
    SupplementNoNo
    PMAOriginalYesYes
    Periodic Report (Annual)YesNo (Invoice)
    Panel Track SupplementYesYes
    Normal 180-day SupplementYesYes
    Real- Time SupplementYesYes
    30 Day NoticeYesYes
    Manufacturing/Sterilization Site ChangeNoNo
    PMA Post Approval Study Labeling UpdateNoNo
    Special PMA Supplement: Changes Being EffectedNoNo
    Trade Name SupplementNoNo
    Any submission that meets the criteria for an exemptionNoYes


  3. Complete the Medical Device User Fee Cover Sheet (Form FDA-3601) (see instructions in next section), if required.

  4. Send your payment with a completed copy of the Medical Device User Fee Cover Sheet (Form FDA-3601) (see instructions below).

  5. Send your application with a completed copy of the Medical Device User Fee Cover Sheet (Form FDA-3601).

Back to Top Arrow


Complete the Medical Device User Fee Cover Sheet

Complete the Medical Device User Fee Cover Sheet (Form FDA-3601) online. The Medical Device User Fee Cover Sheet and instructions are available online.

Applicants must register to create a Medical Device User Fee Cover Sheet. To complete the registration process at least one of the following numbers specific to the organization is required:

  • Organization Number

  • Duns and Bradstreet Number (DUNS)

  • Employer Identification Number (EIN)

A Principal Point of Contact (PPOC) from the organization must also be identified to be responsible for validating users for security purposes.

After registration and creation of a user name and password, the applicant will receive a confirmation email, after which the cover sheet creation page can be accessed. A unique user fee Payment Identification Number will be generated on the cover sheet upon completion. Three copies of the completed User Fee Cover Sheet are required: one copy for your payment, one copy for your 510(k) submission, and one copy for your records.

Frequently Asked Questions addresses common questions regarding the Medical Device User Fee Cover Sheet.

凡来源为本站的文章,版权为本站所有,转载请注明出处!
肯达信,中国最专业的验厂咨询验厂辅导机构,助您顺利通过验厂
客服中心

您好,我是肯达信管理顾问公司客服,欢迎咨询!

廖幼灵

您好,我是肯达信管理顾问公司客服,欢迎咨询!

陈容珍

您好,我是肯达信管理顾问公司客服,欢迎咨询!

杨老师

您好,我是肯达信管理顾问公司客服,欢迎咨询!

王老师

面向全国客户服务热线

400-690-0031

24小时热线

18575592846


展开客服