Affirmation of Compliance
(A of C)
and
FSMA Update
Presented by Cornelia Rooks
Registrar Corp
AIFBA November 2015
Entry Information
 AVOIDING DETENTION
 Entries subject to FDA jurisdiction must have:
 Electronic entries include CBP data (Importer & Consignee, Tariff code, etc)







plus FDA specific data:
FDA Country of Origin;
FDA Product Code;
FDA Manufacturer;
FDA Shipper;
Product Description;
Affirmations of Compliance;
Quantity and Value.
Affirmation of Compliance (A of C Code)
 One of FDA’s functions is the automated screening of
FDA regulated import entries to determine:
 which entries "MAY PROCEED" without FDA examination
and
 which entries require further "FDA REVIEW.”
 Affirmation of Compliance (A of C) codes, are one data
element used in this screening process.
A of C Code
 Use of these codes does not guarantee a May Proceed,
as the FDA line or other FDA lines in the entry, may be
subject to routine surveillance or may fall under other
screening criteria resulting in a directed exam or a
detention without physical examination.
A of C Code
 Using the A of C code, the filer affirms the firm or
product identified meets requirements specific to each
code.
 While submission of this information is currently
voluntary, transmission of the data may expedite initial
screening and further review of an entry.
 The manufacturer or shipper should be able to indicate
when these affirmations should be used and supply the
qualifier information when required.
Example
Product Code EJI
CDRH Classification Panels

73 Anesthesiology
 74 Cardiovascular
 75 Chemistry
 76 Dental
 77 Ear, Nose and Throat
 78 Gastroenterology and
Urology
 79 General and Plastic
Surgery
 80 General Hospital
 81 Hematology
**Note: Used in Product Code
Builder
82 Immunology
83 Microbiology
84 Neurology
85 Obstetrics and
Gynecology
86 Opthalmics
87 Orthopedics
88 Pathology
89 Physical Medicine
90 Radiology
91 Toxicology
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm
Example
A Of C Code and Qualifier
PMN-K875196
510k
Premarket Notification
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm
RA-No
performance std
RB Comply
performance std
RC DO NOT
COMPLY D or E
RD DO NOT
COMPLy being
brought into
compliance
CDRH Database
Drug Databases
http://labels.fda.gov/
http://www.accessdata.fda.gov/script
s/cder/drls/default.cfm
References
 www.registrarcorp.com
 http://www.fda.gov/forindustry/importprogram/ucm349
871.htm
 http://www.fda.gov/downloads/ForIndustry/ImportProgr
am/UCM459926.pdf
 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPC
D/classification.cfm
 http://www.fda.gov/Drugs/InformationOnDrugs/ucm142
438.htm
 http://labels.fda.gov/
Foods/FSMA
FDA Food Safety Modernization Act (FSMA)
Enacted by Congress and signed into law by President
Obama on January 4, 2011
FDA Food Safety Modernization Act (FSMA)
FSMA REQUIRES FDA TO ISSUE RULES
- Preventive Controls for Human and Animal Food
- Produce Safety
- Foreign Supplier Verification Program
- Third Party Auditor
- Sanitary Transport
- Intentional Adulteration
Also: Voluntary Qualified Importer Program Guidance
FDA’s FSMA Rules:
Deadline and Compliance Dates
Rule
Final Rule
Deadline
Compliance
Other
Small
Very Small
PC Human
Food
8/30/2015(Pub
9/17/15)
1 year
2 years
3 years
PC Animal
Food
8/30/2015(Pub
9/17/15
1 CGMP/ 2
PC
2 CGMP/ 3 PC 3 CGMP/ 4 PC
FSVP
10/31/2015
In general, 6
months after
PC final rules
become
effective
In general, 6
months after
PC final rules
become
effective
In general, 6
months after
PC final rules
become
effective
Produce Safety 10/31/2015
2 years
3 years
4 years
Sanitary
Transport
3/31/2016
1 year
2 years
N/A
Intentional
Adulteration
5/31/2016
1 year
2 years
3 years
Preventive Controls for Human Foods
 Facilities that manufacture, process, pack or hold human
food, not farm or retail
 Applies to domestic and imported food
 Some exemptions and modified requirements apply
 Updated the Current Good Manufacturing Practices
 Requires implementation of a food safety plan
FSMA Foreign Supplier
Verification Program
FSMA Requires FDA to Issue Regulations Requiring
Importers to Verify the Safety of Imported Food
Proposed Rule Would Require Identification of FSVP
Importer for Each Entry
Final Rule Due October 31
FSVP Proposed Requirements
 Importers would be responsible for ensuring that the food
they bring into the U.S. meets FDA safety standards
 All importers must develop, maintain and follow an FSVP, unless
otherwise exempted
•
•
•
•
•
•
•
Hazard Analysis
Conduct a Risk Evaluation
Verification Activities
Recordkeeping
Review Complaints
Investigate and Take Corrective Actions
Periodic Reassessment
Voluntary Qualified Importer Program
(“VQIP”)
Fast Lane for Food Imports
Expedited Entry
Expedited Lab Analysis
Dedicated Help Desk
Annual Fe: Estimated First Year Fee= $16,400.00
VQIP
When?
Importers May Apply Annually January – March
VQIP Year Runs From October to September
First Year Anticipated to be 2018
Which Foods
- Nothing on Import Alert or Recall
- Must be From Supplier Certified by FDA Accredited
Auditor
- Must Be Identified on VQIP Application
--- No Additions During the Year
Accredited Auditors
Required for:
Voluntary Qualified Importer Program
Food Certifications
May be Used for FSVP Compliance (optional)
Final Rule Due October 31
Registrar Corp Worldwide Offices
Contact Us
Registrar Corp Headquarters
144 Research Drive
Hampton, Virginia
USA 23666
P: +757-224-0177
F: +757-224-0179
E: info@registrarcorp.com
www.registrarcorp.com
FDA Update
For Customs Brokers
And
Importers
Presented by:
Cornelia Rooks , Senior Regulatory Specialist
Registrar Corp
Products Regulated by the FDA
• Food and Beverages
• Dietary Supplements
• Food additives and food contact substances
•
•
•
•
•
•
Drugs
Biologics
Cosmetics
Medical Devices
Radiation Emitting Devices
Tobacco
Intended Use
Intended Use May be Established By:
•Claims stated on the product labeling, in advertising, on the
Internet, or in other promotion materials
• Consumer perception, which may be established through
the product’s reputation
• Ingredients that may cause a product to be considered a
drug because they have a well-known (to the public and
industry) therapeutic use
The intended use of a product determines
how the product will be regulated
Dietary supplement - a product taken by mouth that
contains a "dietary ingredient" intended to supplement the
diet.
Cosmetic – an article intended to be “applied to the
human body… for cleansing, beatifying, promoting
attractiveness, or altering the appearance”
Drug – an article “intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of disease” or
“intended to affect the structure or function of the body”
The intended use of a product determines whether it is a
“Medical Device” and how it is classified as a Device.
Device - an instrument, apparatus, implement,
machine, contrivance, implant, in vitro reagent, or
other similar or related article . . . intended for use
in the diagnosis of disease or other conditions, or in
the cure, mitigation, treatment, or prevention of
disease, in man or other animals, or intended to affect
the structure or any function of the body of man or
other animals, and which does not achieve its
primary intended purposes through chemical action
within or on the body of man or other animals and
which is not dependent upon being metabolized for
the achievement of its primary intended purposes.
Food (Including Supplements)
• Facilities must be registered with FDA (Bioterrorism Act);
Foreign Facilities Must Designate a U.S. Agent for FDA Communications
Proposed Amended Rule: DUNS requirement coming?
•Prior Notice
• Food must be labeled properly
• Good Manufacturing Practices must be followed
• Food must not be “Adulterated”
• For shelf-stable, sealed foods,
“FCE” registration and process
filing (SID) may be required
(“Refrigerate After Opening”)
•
•Food Canning Establishment (FCE)
•Low Acid and Acidified Foods (LACF)
•Tommy's rule
of thumb...
•If it must be
refrigerated
after opening,
it probably
requires a
process filing.
FDA Food Safety Modernization Act (FSMA)
• The law defines “importer” as:
(A) the United States owner or consignee of the article of food
at the time of entry or
(B) in the case when there is no United States owner or consignee,
the US agent or representative of a foreign owner or consignee
• Food Safety Verification Program requirements will apply to all food
imported by the importer or agent of the importer, unless there’s an exemption.
• In general, importers will be required to conduct the following activities:
•
•
•
•
•
•
•
Hazard Analysis
Conduct a Risk Evaluation
Verification Activities
Recordkeeping
Review Complaints
Investigate and Take Corrective Actions
Periodic Reassessment
Firms Manufacturing, Labeling,
Distributing, and Promoting Drugs
1. “New Drug Application” (NDA) or
Abbreviated New Drug
Application”(ANDA)
OR
2. “Drug Monograph”
*Some exception exist for “grandfathered”
drugs, research, etc.
DRUG MONOGRAPHS
United States Code of Federal Regulations
TITLE 21 C.F.R. — Food and Drugs
CHAPTER I — FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
SUBCHAPTER D — DRUGS FOR HUMAN USE
PART 331 — ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE
PART 332 — ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
PART 333 — TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
PART 335 — ANTIDIARRHEAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
PART 336 — ANTIEMETIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
PART 338 — NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
PART 340 — STIMULANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
PART 341 — COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS
FOR OVER-THE-COUNTER HUMAN USE
PART 343 — INTERNAL ANALGESIC, ANTIPYRETIC, AND ANTIRHEUMATIC DRUG PRODUCTS FOR
OVER-THE-COUNTER HUMAN USE
PART 344 — TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
PART 346 — ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
PART 347 — SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
PART 348 — EXTERNAL ANALGESIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
PART 349 — OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
PART 350 — ANTIPERSPIRANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
PART 352 — SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED
INDEFINITELY]
PART 355 — ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
PART 357 — MISCELLANEOUS INTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
PART 358 — MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
Drugs
• Establishments must be registered with FDA
• Drugs must have NDC number
• Drugs must be listed with FDA
• Drugs must be labeled properly
• Good Manufacturing Practices must be followed
• Drugs must not be “Adulterated”
Drug Registration Overview
•
•
•
•
•
•
•
FDA User Fee –no user fee
Device Establishment Registration initial and annual reregistration (between Oct 1 & Dec 31) submitted to FDA
electronically through the Electronic Submissions Gateway
(ESG)
Designate an Registrant contact
Designate a U.S. Agent (foreign establishments only)
Required for manufacturers, contract manufacturers, filers,
packers, repackagers, relabelers and analytical laboratories
Registered establishments appear on FDA’s public database
Establishment Registration is not FDA’s approval of the
facility
Drug Establishment Registration
 The manufacturer has the legal responsibility to register.
 Registration informs FDA that a facility manufactures drug products
intended for sale in the U.S.
 It is required for manufacturers, contract manufacturers, fillers, packers,
repackagers, relabelers, and analytical laboratories
 Drug Establishment Registrations are submitted to FDA electronically
through the Electronic Submissions Gateway (ESG)
 Registered establishments appear on FDA’s public database
 Establishment Registration is not FDA’s approval of the facility
Labeler Codes and NDC Numbers
 A labeler code is unique, 5-digit code assigned by FDA
to identify entities that label drug products (Labelers)
 A firm can have only one labeler code
 The labeler code is used to configure the National Drug
Code (NDC) number
 10 digits (5-4-1 or 5-3-2) configuration
 Unique to the product and packaging
 Three segments:
Segment 1: Labeler Code Segment 2: Product Code Segment 3: Package Code
55555
123
05
55555
1234
5
Electronic Drug Listing
 Drug listings provide information to FDA about the drug products
being manufactured at a drug establishment
 A listing includes: the drug label, description of the drug’s ingredients,
the category for marketing, and the identification of the manufacturer(s)
and labeler
 It is the manufacturer’s responsibility to list the drug products it
manufactures
 Listings are submitted to FDA electronically
 If a manufacturer makes a product for a PLD (contract
manufacturer), the product must be listed under the PLD’s labeler
code and the manufacturer’s labeler code
Medical Devices
• Establishments must be registered with FDA
• Devices must be listed with FDA
• GUDID Being Phased In Now
• Devices must be labeled properly to include (Unique Device
ID)
• Good Manufacturing Practices must be followed
• For some devices, a 510(k) pre-market notification or
PMA (premarket approval) may be required
Medical Device Classification
 Determine how the FDA may classify the device
which one of 3 classes the device falls into
(Unless exempt from premarket notification)
 3 regulatory classes:
• Class I low risk, general controls e.g. sunglasses, bandages
• Class II moderate risk, general and special controls, e.g.
thermometer, powered wheelchair
• Class III high risk, Premarket Approval e.g. excimer lasers , PSA
test
Medical Device Classification
• Classification
determines extent
of regulatory
control
(Risk Based)
• 1700 generic
groups of devices
• Classified within
16 medical
specialties
862 = Chemistry/Toxicology
864 = Hematology/Pathology
866 =
Immunology/Microbiology
868 = Anesthesiology
870 = Cardiovascular
872 = Dental
874 = Ear, Nose and Throat
876 = Gastro/Urology
878 = General Plastic
Surgery
880 = General Hospital
882 = Neurological
884 =
Obstetrical/Gynecological
886 = Ophthalmic
888 = Orthopedic
890 = Physical Medicine
892 = Radiology
21 CFR 862-892
CDRH Classification Panels
 73 Anesthesiology
 74 Cardiovascular
 75 Chemistry
 76 Dental
 77 Ear, Nose and Throat
 78 Gastroenterology and
Urology
 79 General and Plastic
Surgery
 80 General Hospital
 81 Hematology
**Note: Used in Product Code
Builder
82 Immunology
83 Microbiology
84 Neurology
85 Obstetrics and
Gynecology
86 Opthalmics
87 Orthopedics
88 Pathology
89 Physical Medicine
90 Radiology
91 Toxicology
Product Codes
Classification product
codes are a method of
classifying medical
devices
 3 letter combination
assigned by CDRH
which associates a
device’s type with a
product
classification
 Help to delineate
technology and
indication subgroups
within a regulation
Medical Device Registration Overview
•
FDA User Fee -2016 is $3,845 USD
• Device Establishment Registration initial and annual reregistration (between Oct 1 & Dec 31) submitted thru FURLs
• Designate an Official Correspondent
• Designate a U.S. Agent (foreign establishments only)
• Owner/Operator Number Assignment
• Registration Number Assignment
• Listing Medical Devices & Device Listing Number
Assignment
• Registered establishments appear on FDA’s public database
• Establishment Registration is not FDA’s approval of the
facility
Activity
Register
List
Pay
Fee
Contract manufacturer (including contract packagers) 807.20(a)(2)
YES
YES
YES
Contract sterilizer 807.20(a)(2)
YES
YES
YES
Device being investigated under IDE 807.40(c)
NO
NO
NO
Domestic Distributor that does not import devices 807.20(c)(3)
NO
NO
NO
Any foreign establishment involved with the manufacture,
preparation, propagation, compounding, assembly, or processing
of a device intended for United States
YES
YES
YES
Import agent, broker, and other parties who do not take first
possession of a device
NO
NO
NO
Initial Importer 807.40(a)
YES
NO
YES
Maintains complaint files as required under 21 CFR 820.198
YES
YES
YES
Manufacturer of accessories or components that are packaged or
labeled for commercial distribution for health-related purposes to
an end user 807.20(a)(6)
YES
YES
YES
NO
NO
Manufacturer of components, that are not otherwise classified as a
finished device, that are distributed only to a finished device
NO
manufacturer 807.65(a)
3/11/2016
Activity
Register
List
Pay
Fee
Manufacturer (including Kit Assemblers) 807.20(a)
YES
YES
YES
Manufactures a custom device 807.20(a)(2)
YES
YES
YES
Refurbishers or remarketers of used devices already sold
in U.S.
NO
NO
NO
Relabeler or Repackager 807.20(a)(3)
YES
YES
YES
Remanufacturer and Wholesale distributor
YES
YES
YES
Reprocessor of single use devices 807.20
YES
YES
YES
Specification Consultant Only
NO
NO
NO
Specification Developer 807.20(a)(1)
YES
YES
YES
YES
Domestic Establishments
YES
YES
YES
YES
U.S. Manufacturer of export only devices 807.20(a)(2)
Manufacturer (including Kit Assemblers) 807.20(a)
YES
3/11/2016
Foreign Establishments
Requirements for Registration and Listing
Activity
Register
List
Pay
Fee
Contract manufacturer (including contract packagers) 807.40(a)
YES
YES
YES
Contract sterilizer 807.40(a)
YES
YES
YES
Device being investigated under IDE 812.1(a)
NO
NO
NO
Foreign exporter of devices in foreign countries 807.40(a)
YES
YES
YES
Foreign Manufacturers (including Kit Assemblers) 807.40(a)
YES
YES
YES
Maintains complaint files as required under 21 CFR 820.198
YES
YES
YES
Manufacturer of accessories or components that are packaged or
labeled for commercial distribution for health-related purposes to
an end user 807.20(a)(5)
YES
YES
YES
Manufacturer of components that are distributed only to a finished
device manufacturer 807.65(a)
NO
NO
NO
Relabeler or Repackager 807.20(a)(3)
Remanufacturer
YES
YES
YES
3/11/2016
Other Considerations
 The Product:
 May be a combination product
• Combination products are therapeutic and diagnostic products that
combine drugs, devices, and/or biological products
 May be a medical device and also an electronic radiation
emitting product with additional requirements. Any product that
contains an electronic circuit and emits electronic product
radiation (any ionizing or non-ionizing electromagnetic or
particulate radiation, or any sonic, infrasonic, or ultrasonic
wave
• Final regulations in 21 CFR 1000- 1299
Radiation Emitting Devices
• Any product that contains an electronic circuit and emits electronic product
radiation (any ionizing or non-ionizing electromagnetic or particulate radiation, or
any sonic, infrasonic, or ultrasonic wave
•All REDs must designate a U.S. Agent for service of process
• Product Reports
• Annual Reports
• “Accession Number”
• Form 2877
An “Unapproved
New Drug”
might be a
cosmetic product
or dietary supplement
that has been
labeled in a way
that causes FDA
to deem it a “drug.”
Questions?
Registrar Corp
144 Research Drive, Hampton, Virginia USA 23666
P: +757-224-0177
F: +757-224-0179
E: info@registrarcorp.com
www.registrarcorp.com
Registrar Corp Worldwide Offices
Contact Us
Registrar Corp Headquarters
144 Research Drive
Hampton, Virginia
USA 23666
P: +757-224-0177
F: +757-224-0179
E: info@registrarcorp.com
www.registrarcorp.com