1. 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

2. 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

3. 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

4. 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.)

5. 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

6. 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)

7. 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

8. 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

9. 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.

10. 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

11. 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.

12. 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

13. 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

14. 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.

15. CODE - QUALIFIER EXAMPLES
Note: Should always be the DEV associated with the foreign manufacturer and not the US Specifications Developer.
DEV or DII or PMA - P IDE - G DFE or LST - E PMN - K MDL

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

17. CDRH Industry Letter Medical Devices

18. 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 #

19. Research Use Only – In Vitro Diagnostic
Special product codes – CSMS #
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)

20. 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

21. CDRH Industry Letter Electronic Products Radiation Control

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

23. 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

24. 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

25. 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

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

27. LINKS FDA home page National Drug Code directory www.fda.gov

28. Additional LINKS FDA Product Code Builder Cosmetics Import Refusals
Cosmetics
Import Refusals
CSMS ABI Messages -

29. QUESTIONS