Essentials of FDA Data Element
Submissions
FDA/NCBFAA Webinar
Presented by Kelle R. Fry
FDA Division of Import Operations and Policy
September 8, 2011
OASIS and MARCS Imports Entry Review
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MARCS Imports
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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
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Interface between CBP and FDA remains unchanged
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MARCS Imports Entry Review Implemented
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FDA District Offices and Covered Ports
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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
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MARCS Imports Entry Review
Implementation – Tentative Dates
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Chicago District
Detroit District
New England District
Southwest Import District
Southwest Import District
Southwest Import District
Southwest Import District
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September 20, 2011
October 2011
October 2011
November 2011
November 2011
November 2001
December 2011
Arizona Ports
Texas Ports
California Ports
Other Ports located in non-Import Districts (Kansas, Colorado,
Iowa, etc.)
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MARCS Imports Entry Review/Predict
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EFFICIENCY
 Expedites clearance of
 Performs
lower risk products
automated database look-ups
 Changes
made to data submitted are tracked and that
information is used to adjust the scores for future
lines
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
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)
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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.
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These look-ups are performed using the Affirmation of
Compliance information submitted by the filers
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Failure of this automated process will hold the line for
further review by FDA
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Automated Database Lookups - PASS/FAIL
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These holds cause delays and increased
workload for the reviewer to perform manual
look-ups
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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
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DATA QUALITY
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Addresses the historic data quality trends
exhibited by filers.
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Filers that submit bad data that requires
modifications and rescreening of a line will be
penalized with a risk score increment.
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Over time the scores can go down with the
submission of good data.
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Data Quality
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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
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DEV used with accurate registration number for foreign
device manufacturer
NDA used with accurate New Drug Application number
for new drug
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Firm Information
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Query ACS before adding new record
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CBP firm identifiers create a new record
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Incorrect MID may cause hit for Import Alert
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Site specific firm information needed for food,
medical devices, etc.
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Product Information
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Product Code and Importer’s description should match
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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
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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
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Product Information –
Importer’s Description
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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
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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
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Affirmation of Compliance Codes MEDICAL DEVICES
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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]
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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.
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CODE - QUALIFIER EXAMPLES
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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
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Other Medical Device AofC Codes
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IRC – Impact Resistant Lens Certification
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LWC (Electrode) Lead Wire or Patient Cable
 Product Codes
include in CDRH Industry Guidance
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CDRH Industry Letter
Medical Devices
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http://www.fda.gov/MedicalDevices/Resourcesf
orYou/Industry/ucm248321.htm
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Medical Devices –
PARTS, Accessories, Components
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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
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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
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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)
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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 #
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Research Use Only – In Vitro Diagnostic
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Special product codes – CSMS #11-000086
1.
Device/Product Name FDA Product Code
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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)
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Affirmation of Compliance Codes –
Radiation Emitting Products
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EPRC Accession number (ACC) or
EPRC Annual Report Number (ANC)
EPRC Model Number ( MDL)
 AND
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Affirmation code from Form FDA-2877
 RA1,
RB, RC, RD
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CDRH Industry Letter
Electronic Products Radiation Control
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http://www.fda.gov/MedicalDevices/Resourcesf
orYou/Industry/ucm271180.htm
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Affirmation of Compliance Codes
Both Medical Device & Radiation Emitting
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Need to transmit AofC codes for both
 Industry Letter
issued by CDRH today
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Affirmation of Compliance Codes
Drugs
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Currently still a manual process
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Send appropriate registration, listing, approval related
AofC codes
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REG, LST, NDA (or other)
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LST is same as NDC #
CDER to update code and qualifier information to
include format information
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Affirmation of Compliance Codes
Biologics
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Licensed products License Number (BLN) or Submission
Tracking Number (STN)
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Investigational products to verify IND or IDE
Affirmations of Compliance.
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Human Tissue products - Registration Number (HRN)
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CBER products considered devices - PMA, 510k, NDAs,
ANDs
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Quantity Submission
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Should be submitted to include all packages with
labels or labeling
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Should not include such information as shipping
container, pallets, etc.
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Document available in Product Code Builder
Tutorial
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ITACS Implementation
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After full MARCS Entry Review Implementation
 Document Submission
 Availability Submission
 Check
Line and Entry Status
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LINKS
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FDA home page
 www.fda.gov

National Drug Code directory
 http://www.fda.gov/Drugs/InformationOnDrugs/uc
m142438.htm
 Drugs@FDA
 http://www.accessdata.fda.gov/scripts/cder/drugsatfda/
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Additional LINKS
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FDA Product Code Builder
 http://www.accessdata.fda.gov/scripts/ora/pcb/pcb.
htm
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Cosmetics
 http://www.fda.gov/Cosmetics/default.htm
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Import Refusals
 http://www.fda.gov/ForIndustry/ImportProgram/Im
portRefusals/default.htm
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CSMS ABI Messages  http://apps.cbp.gov/csms/csms.asp?display_page=1
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QUESTIONS
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