Medical Device User Fee Cover Sheet 3601

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MDUFA Cover Sheets | FDA

https://www.fda.gov/industry/medical-device-user-fee-amendments-mdufa/mdufa-cover-sheets

Information about the Medical Device User Fee Cover Sheet is required for a Medical Device Application Submission. ... Form FDA 3601 (01/07) Content current as of: …

Medical Device User Fees | FDA

https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/medical-device-user-fees

Send a printed copy of the Medical Device User Fee Cover Sheet (Form FDA-3601) with the payment. This must include the Payment Identification Number …

Federal Register /Vol. 86, No. 169/Friday, …

https://www.govinfo.gov/content/pkg/FR-2021-09-03/pdf/2021-19116.pdf

fee is submitted. Form FDA 3601, the ‘‘Medical Device User Fee Cover Sheet,’’ is designed to provide the minimum necessary information to determine whether …

Form 3601 Medical Device User Fee Cover Sheet - OMB …

https://omb.report/icr/201907-0910-009/doc/93198901

Form 3601 Medical Device User Fee Cover Sheet. ( ) ⚠️ Notice: This form may be outdated. More recent filings and information on OMB 0910-0511 can be found …

Medical Device User Fee Cover Sheet and Device …

https://omb.report/omb/0910-0511

Form FDA 3601, the "Medical Device User Fee Cover Sheet", is designed to provide the minimum necessary information to determine whether a fee is required for review of an …

Federal Register /Vol. 85, No. 114/Friday, June 12, …

https://www.govinfo.gov/content/pkg/FR-2020-06-12/pdf/2020-12768.pdf

Medical Device User Fee Cover Sheet, Form FDA 3601 and Device Facility User Fee Cover Sheet, Form FDA 3601a OMB Control Number 0910–0511— Revision …

MDUFMA Cover Sheet - REGINFO.GOV

https://www.reginfo.gov/public/do/DownloadDocument?objectID=15701401

MEDICAL DEVICE USER FEE COVER SHEET PAYMENT IDENTIFICATION NUMBER: MD Write the Payment Identification number on your check. A completed cover sheet …

Pre-Market Clearance and Approval - Sterling Medical Devices

https://sterlingmedicaldevices.com/landing/pre-market-clearance-and-approval

Medical Device User Fee Cover Sheet (FDA Form 3601) CDRH Premarket Review Cover Sheet (FDA Form 3514) 510(k) Cover Letter; Indications for Use (FDA …

View Information Collection (IC) - REGINFO.GOV

https://www.reginfo.gov/public/do/PRAViewIC?ref_nbr=201001-0910-015&icID=6227

IC Title: Medical Device User Fee Cover Sheet - FDA Form 3601: Agency IC Tracking Number: Is this a Common Form? No IC Status: Modified Obligation to Respond: …

Federal Register :: Agency Information Collection …

https://www.federalregister.gov/documents/2018/12/28/2018-28220/agency-information-collection-activities-proposed-collection-comment-request-medical-device-user-fee

Because the submission of user fees concurrently with applications and supplements is required, the review of an application cannot begin until the fee is …

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