How To Obtain A Small Business Designation (SBD) With The FDA

How to obtain a Small BusinessDesignation (SBD) with the FDAa.k.a. How to save 10 grand on your 510(k) feeCopyright 2021 leanRAQA, LLC. All rights reserved.

FDA SmallBusinessProgramIf you’re a smallbusiness or start-upplanning asubmission with theFDA, you shouldDEFINITELY knowabout FDA’s SmallBusiness Program.Copyright 2021 leanRAQA, LLC. All rights reserved.CDRH's Small BusinessProgram determineswhether a business isqualified and certifiedas a "small business"and eligible for areduced fee for sometypes of CDRHsubmissions thatrequire a user fee.Gross receipts & sales 100 million for themost recent tax year2

Great, but how much is the discount?* For FY2021Standard Fee*Small Business Fee*Discount513(g) 4,936 2,468 2,468(50% off)510(k) 12,432 3,108 9,324(75% off)De Novo 109,697 27,424 82,273(75% off)PMA 365,657 91,414 274,243(75% off)Annual EstablishmentRegistration 5,546No discount for small businesses But at least the above savings can help youpay for your annual establishment registration!Copyright 2021 leanRAQA, LLC. All rights reserved.3

I need this.When shouldI apply?It may take up to 2 monthsso apply at least 60 daysbefore you need itWhen shouldI renew?The small business statusexpires on September 30of the fiscal year in whichit is grantedEach FDA fiscal yearstarts October 1stCopyright 2021 leanRAQA, LLC. All rights reserved.A new request must besubmitted and approvedeach fiscal year to qualifyas a small businessIf you can, apply asearly as August 1st4

ExampleA business that obtained smallbusiness status on Nov. 7, 2020 willhave this status through Sep. 30,2021.FY2021 Time to(re)-apply!FY2022 Submitting a request in Sep. 2021may not result in a response prior toOct. 1. If you do receive the responsein Sep. 2021, you will not be able touse the small business decisionnumber after the start of the newfiscal year (Oct. 1, 2021).Copyright 2021 leanRAQA, LLC. All rights reserved.5

Important Obtaining a Small Business status is NOTthe same thing as doing your EstablishmentRegistration, which is done in FURLS oncecommercialization has started and theneach year between Oct. 1 and Dec. 31.Submission fees are paid throughthe User Fee System (MDUFA)Copyright 2021 leanRAQA, LLC. All rights reserved.6

ImportantIf you did not get your Small BusinessDesignation prior to paying submission fees,FDA will not refund you.Small business reduced fee for submission doesNOT apply if you’re using a 3rd party reviewer(only works if submitting / paying directly to FDA)Copyright 2021 leanRAQA, LLC. All rights reserved.7

Let’s get started.Equipment needed: your favorite bottle (full)-- FullCopyright 2021 leanRAQA, LLC. All rights reserved.8

First ThingsFirstCopyright 2021 leanRAQA, LLC. All rights reserved.Go to https://userfees.fda.gov/OA HTML/mdufmaCAcdLogin.jsp9

First ThingsFirstHave you paid the user fee before(i.e., do you have a User Fee System Account)?YesLog in to retrieve yourOrganization ID NumberNoCreate your UserFee System AccountSkip to page 17Copyright 2021 leanRAQA, LLC. All rights reserved.10

First ThingsFirstHave you paid the user fee before(i.e., do you have a User Fee System Account)?Unsure?Click on “New User? Please register ”,then perform a search using one of the following Copyright 2021 leanRAQA, LLC. All rights reserved.Paid PIN or Cover Sheet #Invoice #Email AddressOrganization #Employer ID #DUNS Numberwww.fdadunslookup.com11

If no resultsCopyright 2021 leanRAQA, LLC. All rights reserved.Click on the “I am a new FDA UserFee Organization” radio button, thenclick “Go”12

If no resultsCopyright 2021 leanRAQA, LLC. All rights reserved.Fill out the required search fields,then click “Go”13

If STILL noresultsCopyright 2021 leanRAQA, LLC. All rights reserved.Select “I am a new Organization”,then click “Go”14

Create a newUser FeeaccountCopyright 2021 leanRAQA, LLC. All rights reserved.Fill out the required fields, thensubmit. Note you need your FederalEmployer Identification Number (EIN)and it needs to match the EIN on yourtax return.15

Welcome toyour UserFee (MDUFA)AccountCopyright 2021 leanRAQA, LLC. All rights reserved.You are then logged into the UserFee Website and the FDA UserFees main page.Click “Go” on one of the options16

Click on the “Profile” buttonAlmostthere!-- 3/4Copyright 2021 leanRAQA, LLC. All rights reserved.17

This is it!Copyright 2021 leanRAQA, LLC. All rights reserved.Your Organization ID number18

If you’restuck, it’sprobablytime to giveus a call.Detailed steps inFDA User Fee Account CreationProcess User GuideMichelle LottPrincipal and Founder520.275.9838michelle@leanRAQA.comCopyright 2021 leanRAQA, LLC. All rights reserved.19

Note your Organization ID number on apost-it and let’s continue, shall we?Copyright 2021 leanRAQA, LLC. All rights reserved.20

Small Business Requestfor U.S. firmsCopyright 2021 leanRAQA, LLC. All rights reserved.21

SmallBusinessRequest forU.S. FirmsCompleteFDA Form 3602Copyright 2021 leanRAQA, LLC. All rights reserved. If your business is a(n) Inc, LLC,partnership, or other legal entity,provide the name used in itsarticles of incorporation, articlesof organization, partnershipregistration, or other similarinstrument filed with the State orother government under whoselaws the firm was created. If the business is a soleproprietorship owned entirely byone individual, provide the nameused when filing Federal, State, orother taxes.22

SmallBusinessRequest forU.S. FirmsCompleteFDA Form 3602 Attach supporting materialsshowing “gross receipts or sales” ofno more than 100 millionLine # refersto line of theIRS FormForm 990 is required for tax-exemptfirms. Taxpayer ID number in the United Statesand outside the United States (Section 11(b)).Copyright 2021 leanRAQA, LLC. All rights reserved.23

SmallBusinessRequest forU.S. FirmsMost recent business tax return Attach a true and accurate copy (acomplete and unaltered copy) ofthe business’s most recentFederal (U.S.) income tax return.FDA cannot accept a foreign taxreturn instead of a Federal (U.S.)income tax:o 2020 Tax return if qualificationapplication is submitted prior to April 15,2021 and you have not yet filed your2020 tax returnCompleteFDA Form 3602o 2020 Tax return if qualificationapplication is submitted on or after April15, 2021 OR you filed your 2021 taxreturno Extensions require 2019 Tax return & IRSForm 7004Copyright 2021 leanRAQA, LLC. All rights reserved.24

What if it’s going to be my first tax year(no tax return yet)?Copyright 2021 leanRAQA, LLC. All rights reserved.25

SmallBusinessRequest forU.S. FirmsCompleteFDA Form 3602Copyright 2021 leanRAQA, LLC. All rights reserved. A tax return is needed in order toapply for SBD. A personal taxreturn that includes the company'stax form for Schedule C isacceptable as well. If your company has been inbusiness for less than a year, theapplicable date range must befound on the return. Providedocumentation identifying thebusinesses formation to justifythe lack of a full year’s tax return.26

SmallBusinessRequest forU.S. Firms A tax return is required for everyyear you take advantage of theSBD. Therefore, consider filingtaxes even if it is not required (i.e.,the business did not make money).CompleteFDA Form 3602Copyright 2021 leanRAQA, LLC. All rights reserved.27

SmallBusinessRequest forU.S. FirmsCompleteFDA Form 3602Copyright 2021 leanRAQA, LLC. All rights reserved.Other supporting materials: Federal (U.S.) income tax return foreach U.S. affiliate Certified Section III of FDA Form3602A for each foreign affiliate e-file form submitted to the IRSmay be used if it includes a datedsignature of an officer, partner ormember28

Small Business Requestfor foreign firmsCopyright 2021 leanRAQA, LLC. All rights reserved.29

SmallBusinessRequest forForeignFirmsCompleteFDA Form 3602ACopyright 2021 leanRAQA, LLC. All rights reserved.Send FDA Form 3602A to your National TaxingAuthority for Certification of Section IIINational Taxing Authority thenreturns your FDA Form 3602ASubmit FDA Form 3602A to FDA supporting materials including US Taxreturn for US affiliates and CertifiedSection III for non-US affiliates30

-- 1/2Phew.You should be halfway throughyour bottle at this step.If not, please let us knowhow you’re coping.Copyright 2021 leanRAQA, LLC. All rights reserved.31

Ready to send your Small BusinessRequest ( all supporting materials)?Copyright 2021 leanRAQA, LLC. All rights reserved.32

Don’t forget Fill out top right corner field:FY 2021 The Organization ID Number is theone you retrieved/created on theUser Fee System Sign with wet (i.e., ink) or a validdigital signatureCopyright 2021 leanRAQA, LLC. All rights reserved.33

Sendapplicationform andsupportingmaterials to:Copyright 2021 leanRAQA, LLC. All rights reserved.Mail to:FY 2021 MDUFA Small Business QualificationSmall Business Certification Program10903 New Hampshire AvenueBuilding 66, Room 5305Silver Spring, MD 20993U.S.A.34

Now what?You should receive a letter with asmall busines decision (SBD) numberwithin 60 days (sometimes faster).SBDXXXXXXCopyright 2021 leanRAQA, LLC. All rights reserved.35

-- 1/4Copyright 2021 leanRAQA, LLC. All rights reserved.36

NOW youcan pay areduced feefor yoursubmission Your SBD number is required toverify you are qualified for a feereduction and to complete MedicalDevice User Fee Cover Sheet (FDAForm 3601) A copy of FDA Form 3601 isincluded with your medical devicesubmissions e.g., 513(g) or 510(k) Your payment identificationnumber (PIN) is found on FDA Form3601 You will need it for the CDRHPremarket Review SubmissionCover Sheet (FDA Form 3514)Copyright 2021 leanRAQA, LLC. All rights reserved.37

Credit card(VISA, MasterCard,AMEX or Discover)and/or AutomatedClearing House(ACH) electroniccheck (eCheck)Go to:www.Pay.govAfter submitting your cover sheetclick the 'Pay Now' button and followthe instructions to make payment.To pay later, log into your MDUFAUser Fee account and access yourcover sheet history page by clickingon the 'Previous Cover Sheets' icon atthe top of the page.Click the 'Pay Now' link next to thePIN number you need to pay for.Confirmation of payment made bycredit card/electronic check can bereceived in as little as 48 hours.Copyright 2021 leanRAQA, LLC. All rights reserved.38

WiretransferNote: FDA's taxidentificationnumber is53-0196965Please include/reference yourMDUFA cover sheet PIN with yourwire transfer and send to followingaddress:New York Federal Reserve BankUS Department of TreasuryTREAS NYC33 Liberty StreetNew York, NY 10045FDA Deposit Account Number: 75060099US Department of Treasury Routing/Transit number:021030004SWIFT Number: FRNYUS33Beneficiary:Food and Drug Administration8455 Colesville RoadCOLE-14-14253Silver Spring, MD 20993-0002Copyright 2021 leanRAQA, LLC. All rights reserved.39

In summaryUser Fee System(MDUFA Account)Tax Return /FormsOrganizationID #FDA Form 3602 / 3602ASmall Business Request60 daysFDA letter with SmallBusiness Decision (SBD) #Medical Device User Fee CoverSheet (FDA Form 3601)PaymentIdentification # (PIN)CDRH Premarket Review SubmissionCover Sheet (FDA Form 3514)Copyright 2021 leanRAQA, LLC. All rights reserved.40

-- EmptyHip hip hooray!You did it. Time to refresh your drink.Copyright 2021 leanRAQA, LLC. All rights reserved.41

ReferencesSmall Business allbusiness-determination-sbd-programFDA guidance Medical Device User Fee Amendments sion of Industry and Consumer Education (DICE) 1 (800) 638-2041 or 1 (301) 796-7100DICE@fda.hhs.govFDA Help Desk 1 (301) 796-7200userfees@fda.govCopyright 2021 leanRAQA, LLC. All rights reserved.42

REGULATORY. STRATEGY.Put ’em together and what have you got?A competitive advantage, that’s what!Michelle LottPrincipal and FounderCopyright 2021 leanRAQA, LLC. All rights reserved.520.275.9838michelle@leanRAQA.com

Device User Fee Cover Sheet (FDA Form 3601) A copy of FDA Form 3601 is included with your medical device submissions e.g., 513(g) or 510(k) Your payment identification number (PIN) is found on FDA Form 3601 You will need it for the CDRH Premarket Revie