fda affirmation of compliance codes (aofcs) - miller & co - ncbfaa webinar on fda aofc… ·...

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FDA Affirmation of Compliance FDA Affirmation of Compliance Codes (Codes (AofCsAofCs))

Division of Import Operations and PolicyDivision of Import Operations and PolicySystems BranchSystems Branch

FDA - NCBFAA Webinar

July 2010

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TopicsTopics

Affirmation of Compliance CodesAffirmation of Compliance Codes–– What they areWhat they are–– What theyWhat they’’re used forre used for–– Importance of accuracyImportance of accuracy–– Which codes are required for various FDA Which codes are required for various FDA

regulated productsregulated products–– Common errors transmittingCommon errors transmitting–– Other related data errorsOther related data errors–– Trade responsibilityTrade responsibility

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What they are?What they are?

Codes developed by FDA to be used Codes developed by FDA to be used by ABI filers to provide information by ABI filers to provide information useful in expediting review of entries useful in expediting review of entries subject to FDA authoritysubject to FDA authority

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What are they used for?What are they used for?

The codes and their qualifiers are used The codes and their qualifiers are used to communicate information about to communicate information about registration, licensing, and approval registration, licensing, and approval status of FDAstatus of FDA--regulated productsregulated products

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Importance of AccuracyImportance of Accuracy

Codes and their qualifiers are now Codes and their qualifiers are now used for more than the manual entry used for more than the manual entry review performed by FDA staffreview performed by FDA staff

TheyThey’’re used in automated database re used in automated database looklook--upsups

If information transmitted is invalid If information transmitted is invalid the automated database lookthe automated database look--up will up will failfail

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AofCsAofCs By CenterBy Center

CDRHCDRH–– Medical DevicesMedical Devices–– Radiological Health Electronic ProductsRadiological Health Electronic Products

CFSANCFSAN–– Low Acid Canned FoodsLow Acid Canned Foods

CBER CBER –– Coming SoonComing Soon

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Center for Devices and Radiological HealthCenter for Devices and Radiological Health

The process begins with a determination of whether The process begins with a determination of whether item is a device or radiological health (RH) product item is a device or radiological health (RH) product regulated by FDAregulated by FDA

Next determine the regulatory requirements for Next determine the regulatory requirements for importing the device or RH productimporting the device or RH product–– Requires 510(k), PMA, or is exemptRequires 510(k), PMA, or is exempt–– Requires RH product and annual reportsRequires RH product and annual reports–– Requires establishment registration and device listingRequires establishment registration and device listing–– Requires compliance with Quality Systems regulationRequires compliance with Quality Systems regulation–– Needs impactNeeds impact--resistant lens certification documentationresistant lens certification documentation

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Medical devices and electronic productsMedical devices and electronic products

New affirmation of compliance codes have been created, and New affirmation of compliance codes have been created, and the descriptions of some existing codes have been revised. the descriptions of some existing codes have been revised.

For details, see the ACS admin messages to filers which For details, see the ACS admin messages to filers which issued on October 9, 2009 issued on October 9, 2009 -- CSMS#09CSMS#09--000324; 9/23/2009 000324; 9/23/2009 -- CSMS#09CSMS#09--000315; 3/18/2010 000315; 3/18/2010 -- CSMS#10CSMS#10--000075; 4/6/2010 000075; 4/6/2010 -- CSMS#10CSMS#10--000097000097

Note that affirmations for some electronic products require Note that affirmations for some electronic products require the filing of a second, related affirmation of compliance. the filing of a second, related affirmation of compliance.

PREDICTPREDICT’’s automated lookups for medical devices and s automated lookups for medical devices and electronic products will electronic products will failfail if the data submitted do if the data submitted do not conform to the current codes and definitions.not conform to the current codes and definitions.

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Affirmations of ComplianceAffirmations of Compliance Medical device registration numbersMedical device registration numbers

CodeCode TitleTitle DescriptionDescription

DEVDEV Device Foreign Device Foreign ManufacturerManufacturer Registration NumberRegistration Number

The qualifier for this code should be the The qualifier for this code should be the device registration number issued by CDRH device registration number issued by CDRH for the firm manufacturing the product for the firm manufacturing the product identified in the FDA line.identified in the FDA line.

DFEDFE Device Foreign Device Foreign ExporterExporter Registration Registration NumberNumber

The qualifier for this code should be the The qualifier for this code should be the device registration number issued by CDRH device registration number issued by CDRH for the exporter who exports, or offers for for the exporter who exports, or offers for export, to the U.S. a device manufactured export, to the U.S. a device manufactured or processed by another individual, or processed by another individual, partnership, corporation or association in a partnership, corporation or association in a foreign country, as well as devices originally foreign country, as well as devices originally manufactured in the United States.manufactured in the United States.

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Affirmations of Compliance Affirmations of Compliance Medical device registration numbersMedical device registration numbers


DIIDII Device Initial Device Initial ImporterImporter Registration Registration NumberNumber

The qualifier for this code should be the The qualifier for this code should be the device registration number issued by CDRH device registration number issued by CDRH for the importer who takes first title to for the importer who takes first title to devices imported into the U.S.devices imported into the U.S.

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Device Affirmations of ComplianceDevice Affirmations of Compliance


CPTCPT Device ComponentDevice Component This code should be used when importing a This code should be used when importing a component of a device that requires further component of a device that requires further processing or inclusion into the finished device. processing or inclusion into the finished device. This code is not to be used if the device is This code is not to be used if the device is classified by FDA as a finished device, e.g., classified by FDA as a finished device, e.g., wheelchair component.wheelchair component.

IDEIDE Investigational Investigational Device ExemptionDevice Exemption

The qualifier for this code should be the The qualifier for this code should be the investigational device exemption number issued investigational device exemption number issued by CDRH for the product identified in the FDA by CDRH for the product identified in the FDA line.line.

IRCIRC Impact Resistant Impact Resistant Lens CertificationLens Certification

This code is used to certify that the filer has on This code is used to certify that the filer has on hand the test results or a certificate that shows hand the test results or a certificate that shows that the product on the FDA line has met the that the product on the FDA line has met the standard for impact resistance lens.standard for impact resistance lens.

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LSTLST Device Listing Device Listing NumberNumber

The qualifier for this code should be the device The qualifier for this code should be the device listing number issued by CDRH for the product listing number issued by CDRH for the product identified in the FDA line.identified in the FDA line.

LWCLWC (Electrode) Lead (Electrode) Lead Wire or Patient Wire or Patient CableCable

This code should be used when importing electrode This code should be used when importing electrode lead wires, patient cables, or devices that use them. lead wires, patient cables, or devices that use them. The affirmation means that (1) the device shipment The affirmation means that (1) the device shipment does not contain any predoes not contain any pre--wired electrodes, wired electrodes, electrode lead wires, or patient (transducer) cables, electrode lead wires, or patient (transducer) cables, or (2) any preor (2) any pre--wired electrodes, electrode lead wired electrodes, electrode lead wires or patient cables comply with 21 CFR 898, wires or patient cables comply with 21 CFR 898, Performance Standard for Electrode Lead Wires and Performance Standard for Electrode Lead Wires and Patient Cables.Patient Cables.

MDLMDL Model NumberModel Number This code and qualifier should be the manufacturerThis code and qualifier should be the manufacturer’’s model s model number or catalog number for the product identified in the number or catalog number for the product identified in the FDA line.FDA line.

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PMAPMA Device Premarket Device Premarket Approval NumberApproval Number

The qualifier is for this code should be the device The qualifier is for this code should be the device Premarket Approval (PMA) number, product Premarket Approval (PMA) number, product development protocols (PDP) number or development protocols (PDP) number or Humanitarian Device Exemption (HDE) number Humanitarian Device Exemption (HDE) number issued by CDRH for the product identified in the issued by CDRH for the product identified in the FDA line.FDA line.

PMNPMN Device Premarket Device Premarket Notification Notification Number (510(k))Number (510(k))

The qualifier for this code should be the device The qualifier for this code should be the device premarket notification (510(k)) number issued by premarket notification (510(k)) number issued by CDRH for the product identified in the FDA line.CDRH for the product identified in the FDA line.

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Device Device AofCAofC ExamplesExamples

DEV 3003999999 or 9610123 (DEV 3003999999 or 9610123 (Note: Note: Should always be the DEV associated Should always be the DEV associated with the foreign manufacturer and not with the foreign manufacturer and not US specifications developerUS specifications developer))

DFE 3003999999 or 9710123DFE 3003999999 or 9710123

DII 3003999999 or 1021365DII 3003999999 or 1021365

LST E100100LST E100100

PMN K979999PMN K979999

PMA P979999PMA P979999

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Radiological Health Radiological Health AofCsAofCs

CodeCode TitleTitle DescriptionDescriptionACCACC EPRC EPRC

Accession Accession Number Number

This code and qualifier should be the This code and qualifier should be the Electronic Product Radiation Control Electronic Product Radiation Control (EPRC) product or abbreviated report (EPRC) product or abbreviated report accession number issued by CDRH for the accession number issued by CDRH for the product identified in the FDA line. product identified in the FDA line.

ANCANC EPRC EPRC Annual Annual Report Report Accession Accession Number Number

This code and qualifier should be the EPRC This code and qualifier should be the EPRC current annual report (due annually by current annual report (due annually by September 1) accession number issued by September 1) accession number issued by CDRH for the product identified in the FDA CDRH for the product identified in the FDA line.line.

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Radiological Health Radiological Health AofCsAofCsCodeCode TitleTitle DescriptionDescription

CCMCCM EPRC Certifying EPRC Certifying Component Component ManufacturerManufacturer

This affirmation and qualifier should be used to name the certifThis affirmation and qualifier should be used to name the certifying component ying component manufacturer (CCM) of the certified (EPRC) component incorporatemanufacturer (CCM) of the certified (EPRC) component incorporated in the d in the finished product being imported. As an example, a certified comfinished product being imported. As an example, a certified component ponent manufacturer (CCM) can be the maker of laser optical drives ( CDmanufacturer (CCM) can be the maker of laser optical drives ( CD/ROM, /ROM, CD/RW, DVD/ROM, DVD/RW, etc.) incorporated into laptops, computeCD/RW, DVD/ROM, DVD/RW, etc.) incorporated into laptops, computers, fax rs, fax machines, computer servers, handmachines, computer servers, hand--held computers, audio/video end products, held computers, audio/video end products, boom boxes, entertainment centers, flat screen television producboom boxes, entertainment centers, flat screen television products, ts, automobiles, etc. The name of the CCM manufacturer must match tautomobiles, etc. The name of the CCM manufacturer must match the name he name that appears in the referenced accession number for the laser rathat appears in the referenced accession number for the laser radiation diation product report (ACC) and/or annual report (ANC) affirmations. Tproduct report (ACC) and/or annual report (ANC) affirmations. This his affirmation is only used when the name of the manufacturer of thaffirmation is only used when the name of the manufacturer of the finished e finished product is different from the name of the certifying component mproduct is different from the name of the certifying component manufacturer.anufacturer.As an example, a certified DVD player made by Star Laser Inc. isAs an example, a certified DVD player made by Star Laser Inc. is incorporated incorporated into a laptop manufactured by BB Laptop Company. The import eninto a laptop manufactured by BB Laptop Company. The import entry try declares the manufacturer of the finished product as BB Laptop Cdeclares the manufacturer of the finished product as BB Laptop Company. ompany. The data submitted by the broker for the certified (EPRC) componThe data submitted by the broker for the certified (EPRC) component would ent would look like this:look like this:

CCMCCM code using a qualifier of code using a qualifier of ““Star Laser, Inc.Star Laser, Inc.””ACC / ANCACC / ANC providing the accession number for the laser annual report providing the accession number for the laser annual report 08328570832857--000, which clearly identifies the certified component (EPRC) 000, which clearly identifies the certified component (EPRC) manufacturer as Star Laser, Inc.manufacturer as Star Laser, Inc.MDLMDL AIAMAIAM--12101210RB1RB1, and, andProduct codeProduct code RFY (DVD, RFY (DVD, BluRayBluRay))

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Radiological Health Radiological Health AofCsAofCs

CodeCode TitleTitle DescriptionDescriptionMDLMDL Model Model

numbernumberThis code and qualifier should be the This code and qualifier should be the manufacturermanufacturer’’s model number or catalog s model number or catalog number for the product identified in the number for the product identified in the FDA line.FDA line.

RA1RA1-- RA7, RA7, RB1RB1-- RB2, RB2, RC1RC1-- RC2, RC2, RD1RD1-- RD3RD3

EPRC EPRC Product Product Declaration Declaration xx (FDA xx (FDA 2877)2877)

Various declarations regarding compliance Various declarations regarding compliance or nonor non--compliance of the RH products. compliance of the RH products. Must be used as a standMust be used as a stand--alone alone AofCAofC and and not in combination with ACC or ANC.not in combination with ACC or ANC.

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Radiological Health Radiological Health AofCAofC ExamplesExamples

ACC 982xxxx, 981xxxx, 988xxxx, ACC 982xxxx, 981xxxx, 988xxxx, 989xxxx989xxxx

ANC 093xxxx (no more than two ANC 093xxxx (no more than two years old)years old)

RB1RB1

MDL 65MDL 65--125125

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Special Issues to Consider Special Issues to Consider During Importation processDuring Importation process

Consider doing due diligence by verifying that firm is not on anConsider doing due diligence by verifying that firm is not on an FDA Import FDA Import alert alert http://www.fda.gov/ForIndustry/ImportProgram/ImportAlerts/defaulhttp://www.fda.gov/ForIndustry/ImportProgram/ImportAlerts/default.htmt.htm

Be mindful that the Import for Export (IFE) declaration can onlyBe mindful that the Import for Export (IFE) declaration can only be used for be used for products undergoing further processing. It cannot be used for trproducts undergoing further processing. It cannot be used for transshipment ansshipment of finished devices through the United States. It cannot be usedof finished devices through the United States. It cannot be used to store to store finished devices intended solely for export in US warehouses. finished devices intended solely for export in US warehouses. http://www.fda.gov/ForIndustry/ImportProgram/ImportforExport/defhttp://www.fda.gov/ForIndustry/ImportProgram/ImportforExport/default.htmault.htm

Filer audits and CBP referrals allow FDA to detect cases of imprFiler audits and CBP referrals allow FDA to detect cases of improper oper disclaiming or incorrect declaration of FDA regulated products.disclaiming or incorrect declaration of FDA regulated products.

Supply chain safety is very important to FDA to prevent counterfSupply chain safety is very important to FDA to prevent counterfeit products eit products and illegal goods from entering the US. If you suspect illegal aand illegal goods from entering the US. If you suspect illegal activity on the ctivity on the part of your clients, please report it to FDA and CBP.part of your clients, please report it to FDA and CBP.

Components, entries from Foreign Trade Zones, American Goods RetComponents, entries from Foreign Trade Zones, American Goods Returned, urned, trade show entries, sample entries and any nontrade show entries, sample entries and any non--standard entry raise issues standard entry raise issues within PREDICT and the entire import entry process.within PREDICT and the entire import entry process.

http://www.fda.gov/ForIndustry/ImportProgram/ImportAlerts/default.htm

http://www.fda.gov/ForIndustry/ImportProgram/ImportAlerts/default.htm

http://www.fda.gov/ForIndustry/ImportProgram/ImportforExport/default.htm

http://www.fda.gov/ForIndustry/ImportProgram/ImportforExport/default.htm

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Acidified and low acid canned foods Acidified and low acid canned foods (ALACFs and LACFs)(ALACFs and LACFs)

FCE: Food canning establishment numberFCE: Food canning establishment number

SID: Scheduled process identifier numberSID: Scheduled process identifier number

LACF container dimensions are to be declared LACF container dimensions are to be declared in specific data fields (defined as part of the in specific data fields (defined as part of the ABI to ACS interface), ABI to ACS interface), notnot as affirmations of as affirmations of compliance.compliance.

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Use the appropriate PIC (Process Indicator Use the appropriate PIC (Process Indicator Code):Code):

–– Use Use ““EE”” (Commercially Sterile) for most LACF (Commercially Sterile) for most LACF products, including water activity products, including water activity controlled/formulated products.controlled/formulated products.

–– Use Use ““FF”” (Aseptic) for LACF commercially sterile (Aseptic) for LACF commercially sterile aseptically packagedaseptically packaged products, which may products, which may include various lowinclude various low--acid beverages, puddings, acid beverages, puddings, baby foods, etc.baby foods, etc.

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–– Use Use ““II”” (Acidified) for all acidified products (i.e., (Acidified) for all acidified products (i.e., products covered under 21 CFR 114).products covered under 21 CFR 114).

–– Do Do notnot use other PICs such as use other PICs such as ““TT”” for LACF or for LACF or for ALACF products.for ALACF products.

–– The product description for the entry line should The product description for the entry line should match the description of the food as it was given match the description of the food as it was given to FDA when the scheduled process was filed. to FDA when the scheduled process was filed.

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Use the importerUse the importer’’s text description field to s text description field to supplement the product code description supplement the product code description when necessary, for example, to indicate when necessary, for example, to indicate packing media (oil, brine, tomato sauce, packing media (oil, brine, tomato sauce, etc.) and/or product style (sliced, chopped, etc.) and/or product style (sliced, chopped, etc.), and/or when there is no product code etc.), and/or when there is no product code product name that matches the SID food product name that matches the SID food name.name.

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Common errorsCommon errors

Multiples of the same code are Multiples of the same code are transmitted for a linetransmitted for a line

The qualifier transmitted with a code The qualifier transmitted with a code does not represent the information does not represent the information required (e.g. sending an accession required (e.g. sending an accession number using a REG code)number using a REG code)

Not supplying all codes requiredNot supplying all codes required

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Other data errorsOther data errors

AofCAofC Qualifier information transmitted Qualifier information transmitted in another data field, such as in the in another data field, such as in the ImporterImporter’’s description fields description field

LACF can dimensions transmitted in LACF can dimensions transmitted in alternate fieldalternate field

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Trade Efforts to Expedite FDA Trade Efforts to Expedite FDA Admissibility DecisionsAdmissibility Decisions

When MARCS Imports comes online in a When MARCS Imports comes online in a District, theDistrict, the quality of the data quality of the data submitted to FDA will count more than submitted to FDA will count more than everever

Filers need to work closely with Filers need to work closely with importers to ensure data qualityimporters to ensure data quality

Poor data quality or missing data will Poor data quality or missing data will increase the review timeincrease the review time

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FDA Efforts to Aid Trade FDA Efforts to Aid Trade CommunityCommunity

Look for common errors in Look for common errors in AofCAofC data data transmissiontransmission

Conduct oneConduct one--onon--one outreach to one outreach to resolveresolve

Modify import data systems in attempt Modify import data systems in attempt to enhance future database lookto enhance future database look--up up processesprocesses

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Questions?Questions?

fda affirmation of compliance codes (aofcs) - miller & co - ncbfaa webinar on fda aofc… ·...

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