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FDALos Angeles District Office

10th Annual Biomedical ForumSABPA

Import/Export Challenges and Guidance for FDA Medical Products

April 25, 2015

Dan Solis, DirectorLos Angeles District Import Operations

U.S. Food and Drug Administration

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FDA AUTHORITIES

Office of Regulatory Affairs

Center forFood Safety &Applied Nutrition

Center forDrug Evaluation &Research

Center forBiologics Evaluation &Research

Center forDevices &RadiologicalHealth

Center forVeterinaryMedicine

NationalCenter forToxicologicalResearch

Center forTobaccoProducts

Office of International Programs

Office of Chief Scientist

OFFICE OF GLOBALREGULATORY

OPERATIONS &POLICY

OFFICE OF FOODS and FEED

OFFICE OF MEDICAL PRODUCTS &

TOBACCO

OFFICE OF OPERATIONS

OFFICE OF REGULATORY

AFFAIRS

Office of International

Programs

Center for Food Safety & Applied

Nutrition

Center for Veterinary Medicine

Center for Devices &

Radiological Health

Center for Drug

Evaluation & Research

Center for Biologics

Evaluation & Research Center for

Tobacco

Office of Special Medical Programs

National Center for

Toxicological Research

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FDA Regional Field Office – Pacific Region

Regional Field OfficeOakland, Ca

Los Angeles District Office

Irvine, Ca

San Francisco District OfficeAlameda, Ca

Seattle District Office

Bothell, Wa

Pacific Regional Lab North-WestBothell, Wa

Pacific Regional Lab South-West Irvine, Ca

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FDA Los Angeles District

Los Angeles District OfficeIrvine, Ca

Import Operations

(Port Operations)

Long Beach, Ca

Domestic Investigations

Irvine, Ca

Compliance Branch

Irvine, Ca

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FDA Import Operation MissionPrevention and Investigation of

Adulterated, Unapproved and Misbranded FDA

Products from coming into the United States.

Import Product Review• Entry Review (PREDICT)• Field Examinations• Product Sample Collection• Investigations

Inspections• Establishment Inspections • Facility Inspections • Importer Inspections

Investigations• Consumer Complaints• Emergency Response• Smuggling Investigations

RecallSeizure of Products at the Border

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MAIN IMPORT OPERATIONS OFFICE – Long

Beach, CA

LOS ANGELES AIRPORT – LAX

CENTRALIZED EXAMINATION

STATIONS (CES) 4 -PRICE TRANSFER, FCL,

CAL CARTAGE

Woodland Hills Resident Post –Woodland Hills,

Ca

ONTARIO AIRPORT Resident Post – Ontario, Ca

International Mail Facility (IMF) –

Torrance, Ca

Phoenix Airport–Phoenix, AZ

FDA LOS-DO IMPORT OPERATIONS

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Airport

Airport

Airport

Airport

LOS ANGELES

FLORIDA

DOWNSTATE NEW YORK

UPSTATE NEW YORK

SOUTH WEST IMPORT DISTRICT

IMPORT BRANCHES AND DISTRICT

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Airport

LOS ANGELES

IMPORT PROCESS

CBP FDA

IMPORTATION INTO THE UNITED STATES

REFUSEDDESTROYED

EXPORTED

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foodsProduct info, Firm info,

Country of Mfr. Info, Consignee

Entry filer Customs

OASIS

IMPORT PROCESS

Review?No

FDA district entry reviewer

Yes

DIVISION OF FOOD

DEFENSE

TARGETING (DFDT)

OK?Yes No“May proceed”

message“FDA review”

message

PN screening – food

801(a) screeningPREDICT

othersfoods

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FDA district entry reviewer

Entry filer

Initial action?

Field exam

Sample, analyze

Compliance Officer (Hearings

Officer)

“May proceed”message

Results?

Complianceaction

Detain w/ophysical exam

Detain/Refuse

Set Up Assignments or Investigations

Release

Good

Documentsrequestedby FDA

Bad

IB release

???

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PREDICT AT FDA(PREDICT) - Predictive Risk-based Evaluation for Dynamic Import

Compliance Targeting• Risk assessment tool – Improves screening and targeting• Assesses relative risk of FDA Regulated Products, comparability of

country, intelligence, data mining• Increases speed of FDA releases for low risk foods/compliant products;

reduce sampling and exams• Prioritizes higher risk FDA regulated shipments - increase sampling and

exams• MARCS Entry Review and PREDICT were first deployed in Los Angeles

District. Now all FDA Districts are using PREDICT.

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PREDICT method

• Use automated data mining and pattern discovery

• Utilize open-source intelligence

• Provide automated queries of Center databases where relevant (i.e., registration and listing, marketing approval status, low-acid canned food scheduled processes, etc.)

• Learning algorithm to adjust for future shipments

• Provides information from other ports.

PREDICT LINK

Special Rules for Drugs• Foreign drug firms are required to register their

establishments, and list their products, with the FDA. The required forms (FDA-2656 {Registration of Drug Establishments} and FDA-2657 {Drug Product Listing}) can be requested from the Center for Drug Evaluation and Research, Records Repository Team (HFD-143), 5600 Fishers Lane, Rockville, MD 20857.

• Drugs are restricted from importation unless they are covered under an Investigational New Drug Exemption (IND) or by an approved New Drug Application (NDA). Information on regulations covering INDs or NDAs and application forms should be requested from CDER Executive Secretariat (HFD-8), Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville, MD 20857.

Special Rules for Devices• Devices must meet FDA regulations prior to the

importation of medical devices into the United States. FDA does not recognize regulatory approvals from foreign countries/areas.

• If your device is a type that requires a premarket notification (or 510(k)) submission, you are required to submit a 510(k) when the following occurs: (a) a foreign manufacturer intends to export a medical device to the U.S. that the firm has never before shipped to the U.S.; (b) either the foreign manufacturer or initial distributor changes the intended uses of devices that are legally being marketed in the U.S.; or (c) changes or modifications to a legally marketed device that could significantly affect its safety or effectiveness. Information on how to submit a 510(k) is available athttp://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm.

Special Rules for Devices• All foreign firms are required to both register their establishments, identify a

U.S. Agent, and individually list their devices before they may import them into the United States. Complete information on registration and listing requirements and processes can be obtained from the Registration & Listing website, or by contacting DICE as described below.

• Form FDA 2877 (Declaration for Radiation Standard) http://www.fda.gov/opacom/morechoices/fdaforms/FDA-2877.pdf is required for radiation-emitting electronic products entering the United States.

• Information concerning premarket notification, radiation control standards, or device listing and establishment registration, is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm You may also contact the Center for Devices and Radiological Health, Division of Industry and Consumer Education (DICE), 10903 New Hampshire Avenue, WO66-4613, Silver Spring, MD 20993-0002, (800) 638-2041. Manufacturers outside the U.S. should call: (301) 796-7100. Email dice@fda.hhs.gov

Submission of Documents

• Documents can be submitted by– Word, Pdf, Excel, Common picture files

• When submitting availability of goods for examination, the user may indicate that the goods are located by the consignee as filed in the FDA entry, or another location as entered by the user.

Benefits of ITACS• The ability to submit documents electronically

– Reduces the need for phone calls– Increases predictably by reducing dependence on

faxes and courier delivery• ITACS can be accessed by

https://itacs.fda.gov– Need a valid customs entry number that has been

transmitted to the FDA– In the future, login accounts are planned and FDA

will be able to query FDA firm identifiers and product codes and communicate with FDA.

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Learn More About ITACS

• Take a tutorial –http://www.fda.gov/forindustry/importprogram/ucm296314.htm

• Do not contact the Districts directly about ITACS

• To report problems or ask questions, please send emails to: itacssupport@fda.hhs.gov

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OGA RelationshipsFDA

FOREIGN GOVERNMENTS

CALIFORNIA FDB

LA COUNTY PUBLIC HEALTH

LAPD VICE DIVISIONDEA(Drug Enforcement Administration)

FWS(Fish and Wildlife Service)

US POSTAL INSPECTORS

CBP (CUSTOMS AND BORDER PROTECTION)

HSI (Homeland Security Investigations)

CALIFORNIA DEPT. OF FOOD AGRICULTURE

SHARE THE SAME COMMON GOAL: PROTECT PUBLIC HEALTH

CALIFORNIA DEPT. OF PESTICIDES REGULATION

CA Board of Pharmacy

LA CITY ATTORNEY’S OFFICE

US Dept. of Agriculture (USDA – SITC, FSIS, Aphis, Agri)

CPSC(Consumer Product Safety Commission)

LA CITY FIRE DEPARTMENT

ORANGE COUNTY and Los Angeles DA’s OFFICE

LA DISTRICT ATTORNEY’S OFFICE

NOAA(National Oceanic and Atmospheric Administration )

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FDA’s New Legislations

• Food Safety Modernization Act (FSMA). Signed into law on January 4, 2011. The most sweeping reform of our food safety laws in more than 70 years. It aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it.– Seven Proposed Rules right now:

• Produce Safety (Jan-2013)• Preventive Controls for Human Food (Jan-2013)• Foreign Supplier Verification Program (FSVP) – (Jul-2013)• Accreditation of third-party auditors for foreign facilities (Jul-2013)• Preventive Controls for animal foods (Oct-2013)• Mitigation for Intentional Adulteration of Food (Dec-2013)• Sanitary transportation of human and animal food (Feb - 2014)

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FDA’s New Legislations• The Family Smoking Prevention and Tobacco Control Act (TCA).

Signed into law on June 22, 2009. Gives FDA authority to regulate the manufacture, distribution, and marketing of tobacco products to protect public health. Aims to curb the trend of new users becoming addicted before they are old enough to understand the risks and ultimately dying too young of tobacco-related diseases.

• Food and Drug Administration Safety & Innovation Act (FDASIA). Signed into law on Jul. 9, 2012. Expands the Agency’s authorities and strengthens the agency’s ability to safeguard and advance public health by giving the authority to collect user fees, promoting innovations, increasing stakeholder involvement and enhancing the safety of the drug supply chain

– Prescription drug provisions (PDUFA V)– Medical Device Provisions (MDUFA III)– Generic Drug User Fee Amendments of 2012 (GDUFA)– Biosimilar User Fee Act (BsUFA)

• Drug Quality and Security Act (DQSA). Signed into law on Nov. 27, 2013. Outlines critical steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the U.S.

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Import Alerts • Import Alerts = are public alerts on FDA

products that the Agency has concerns about being Imported into the United States. Information on manufacturers, products and importers are provided as well as guidances.

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

Best Practices• Submission of proper manufacturer information

and address (Good history speeds through entry process)

• Submit correct AofC and hire a competent Customs Broker

• Study Import Alerts and Product requirements –if unsure talk to consultants

• Cooperate with FDA Investigators and submit info ASAP (other wise back to end of line)

• Wait a couple of days after submission before calling a Compliance Officer and know your Entry Number (case number) 24

Best Practices• Email and a follow up phone call for lengthy discussions

needed• Have goods available for FDA Appointments• Be honest with Compliance Officer if error was made• Have all records and documents ready to show if product

is registered – keep all lab analysis results• Do homework on www.FDA.gov website• Do not release goods until you receive the FDA Notice to

“May Proceed”• Cooperate and comply with time frames and directions

from the Compliance Officer

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Common Mistakes• Wrong manufacturer information, address, MID and FEI

numbers• Does not know process and procedures to follow• Calls all FDA extensions• Emails more than 4 FDAers• Demands FDA to release shipments• Falsifying documents – Title 18 • Ignoring FDA Notice of Actions• Ignoring CBP summons and penalty notices• Sells adulterated products into commerce• Does not cooperate with recall coordinator• Submits after the Detention notice due date• Ask FDA to rescind a Refusal 26

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FORMS OF COMMUNICATION WITH FDA in LOS ANGELES IMPORTS

• Phone Numbers for LOS-DO Import Operations (Long Beach, Ca)– General status line (562) 256-7700– Compliance status line (562) 256-7707– Fax line (562) 256- 7701

• General email address: LAIMPORTS@fda.hhs.gov• LAX Office email address: LAXImports@fda.hhs.gov• Los Angeles District Consumer Complaint Hotline: (949) 608-3530• FDA National Emergency Operations Number: 1-866-300-4374 • FDA General Inquiry: 1-888-INFO-FDA • For Adverse Event of illness call 1-800-FDA-1088 or online• For Drug Inquiries: CDERSmallBusiness@fda.hhs.gov or (866)-405-5367• For Medical Device Inquiries: industry.device@fda.hhs.gov or (800) 638-

2041Note: Fastest response is email.

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Email address: Dan.Solis@fda.gov

Carla.Fernandez@fda.hhs.gov

Thank You For Your Attention!

Thank you for comingfor your interestfor taking responsibilityfor your diligence and accuracyfor using this informationfor sharing this informationfor educating yourself via

www.fda.gov