Essentials of FDA Data Element Submissions FDA/NCBFAA Webinar Presented by Kelle R. Fry FDA Division of Import Operations and Policy September 8, 2011 1

OASIS and MARCS Imports Entry Review MARCS (Mission Accomplishments and Regulatory Compliance Services) Replacing OASIS and all other FDA Office of Regulatory Affairs Data Systems MARCS Imports is a name covering all of the Import related databases and related services MARCS Imports Entry Review is one components of MARCS Imports PREDICT is the name given to FDA’s new targeting engine which resides inside MARCS Imports Interface between CBP and FDA remains unchanged

MARCS Imports Entry Review - Implemented FDA District Offices and Covered Ports Los Angeles District New York District San Francisco District Seattle District Atlanta District San Juan District New Orleans District Philadelphia District Florida District Baltimore District Went Live September 7, 2011

MARCS Imports Entry Review Implementation – Tentative Dates Chicago District September 20, 2011 Detroit District October 2011 New England District October 2011 Southwest Import District November 2011 Southwest Import District November 2001 Southwest Import District December 2011 Arizona Ports Texas Ports California Ports Other Ports located in non-Import Districts (Kansas, Colorado, Iowa, etc.)

MARCS Imports Entry Review/Predict EFFICIENCY Expedites clearance of lower risk products Performs automated database look-ups Changes made to data submitted are tracked and that information is used to adjust the scores for future lines

Targeting Rule Categories Legacy and Automated Database Lookups (Presence of necessary Affirmation of Compliance Data) Expert General Intelligence Data Anomalies (Firm Identifier Consistency) Lab Analysis, Field Exam and Facility Inspection Track Record Data Quality ( FDA changes necessary to Product Code, Firms, Country of Origin)

Automated Database Lookups - PASS/FAIL Automated Database Look-ups are performed for those products requiring registration, licensing, listing, and/or approval application information as part of FDA admissibility. These look-ups are performed using the Affirmation of Compliance information submitted by the filers Failure of this automated process will hold the line for further review by FDA

Automated Database Lookups - PASS/FAIL These holds cause delays and increased workload for the reviewer to perform manual look-ups If a line passes the lookup and the risk score is low and product is not subject to an Import Alert, the line has a greater likelihood of being proceeded

DATA QUALITY Addresses the historic data quality trends exhibited by filers. Filers that submit bad data that requires modifications and rescreening of a line will be penalized with a risk score increment. Over time the scores can go down with the submission of good data.

Data Quality Accurate, Consistent, Complete In order for an entry to have a timely review the following are needed: Consistent, accurate identifiers for firms Accurate product codes and product descriptions If provided Affirmations of Compliance Codes should be relevant for the product and the qualifiers should be accurate for the product or firm represented DEV used with accurate registration number for foreign device manufacturer NDA used with accurate New Drug Application number for new drug

Firm Information Query ACS before adding new record CBP firm identifiers create a new record Incorrect MID may cause hit for Import Alert Site specific firm information needed for food, medical devices, etc.

Product Information Product Code and Importer’s description should match In past where product codes and description did not match, FDA may have updated Today such an update may impact scores on subsequent lines from filer Product Codes ending with 99 (Not Elsewhere Classified) should not be sent when there is a more accurate code available In the past FDA may have updated where there was a more accurate product code Today such an update may impact score on subsequent lines from filer AND any line with a 99 will be given a higher risk score

Product Information – Importer’s Description No Misc. information should be conveyed in the Importer Description field No LACF can dimensions No Registration or listing information No Invoice or tracking numbers In past where importer’s description contained non product related information, there was little impact except for FDA data extraction Today such extraneous information may cause automated database look-up failures

Affirmation of Compliance Codes - MEDICAL DEVICES Device Foreign Manufacturer (DEV) or Device Foreign Exporter (DFE) Device Listing (LST) Device Initial Importer (DII) Premarket Application (PMA) [Can be a PMA, a Humanitarian Device Exemption (HDE), or a Product Development Protocol (PDP) number] OR a Premarket Notification Number (PMN) OR an Investigational Device Exemption (IDE) If any of the these are missing or incorrect the lookup will fail.

CODE - QUALIFIER EXAMPLES Note: Should always be the DEV associated with the foreign manufacturer and not the US Specifications Developer. DEV - 3003999999 or 9610123 DII - 3003999999 or 1021365 PMA - P001234 IDE - G01232 DFE - 3003999999 or 9710123 LST - E100100 PMN - K011234 MDL - 650 -182

Other Medical Device AofC Codes IRC – Impact Resistant Lens Certification LWC (Electrode) Lead Wire or Patient Cable Product Codes include in CDRH Industry Guidance

CDRH Industry Letter Medical Devices http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm248321.htm

Medical Devices – PARTS, Accessories, Components Parts – Screws, nuts, and other general purpose parts with no intended medical at time of importation use don’t require FDA declaration. If required by tariff, use CPT Accessories – Always considered to be a finished device and would have it’s own product code or use the device code it is an accessory to – could require 510K or PMA Components – Some are classified as finished devices. Majority are a component requiring further processing. Those requiring further processing need to be declared and use the Component - CPT AofC code, DII, LST (associated with finished product) Component Brokers/Distributors – contracted to manufacturer overseas, import, and sell to Original Equipment Manufacturer (OEM). Not required to LST but needs to get Manufacturer’s LST #

Research Use Only – In Vitro Diagnostic Special product codes – CSMS #11-000086 Device/Product Name FDA Product Code Research use only/hematology devices 81O--TQ Research use only/immunology devices 82O--TR Research use only/microbiology 83O--TT Research use only/pathology 88O--TU Research use only/clinical chemistry devices 75O--TV Research use only/clinical toxicology 91O--TW Other than In Vitro Diagnostic Devices (IDE)

Affirmation of Compliance Codes – Radiation Emitting Products EPRC Accession number (ACC) or EPRC Annual Report Number (ANC) EPRC Model Number ( MDL) AND Affirmation code from Form FDA-2877 RA1, RB, RC, RD

CDRH Industry Letter Electronic Products Radiation Control http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm271180.htm

Affirmation of Compliance Codes Both Medical Device & Radiation Emitting Need to transmit AofC codes for both Industry Letter issued by CDRH today

Affirmation of Compliance Codes Drugs Currently still a manual process Send appropriate registration, listing, approval related AofC codes REG, LST, NDA (or other) LST is same as NDC # CDER to update code and qualifier information to include format information

Affirmation of Compliance Codes Biologics Licensed products License Number (BLN) or Submission Tracking Number (STN) Investigational products to verify IND or IDE Affirmations of Compliance. Human Tissue products - Registration Number (HRN) CBER products considered devices - PMA, 510k, NDAs, ANDs

Quantity Submission Should be submitted to include all packages with labels or labeling Should not include such information as shipping container, pallets, etc. Document available in Product Code Builder Tutorial

ITACS Implementation After full MARCS Entry Review Implementation Document Submission Availability Submission Check Line and Entry Status

LINKS FDA home page National Drug Code directory www.fda.gov http://www.fda.gov/Drugs/InformationOnDrugs/ucm142438.htm Drugs@FDA http://www.accessdata.fda.gov/scripts/cder/drugsatfda/

Additional LINKS FDA Product Code Builder Cosmetics Import Refusals http://www.accessdata.fda.gov/scripts/ora/pcb/pcb.htm Cosmetics http://www.fda.gov/Cosmetics/default.htm Import Refusals http://www.fda.gov/ForIndustry/ImportProgram/ImportRefusals/default.htm CSMS ABI Messages - http://apps.cbp.gov/csms/csms.asp?display_page=1

QUESTIONS