affirmation of compliance (a of c) and fsma update presented by cornelia rooks registrar corp aifba...
TRANSCRIPT
Affirmation of Compliance(A of C)
andFSMA Update
Presented by Cornelia Rooks Registrar Corp
AIFBA November 2015
Entry Information
AVOIDING DETENTIONEntries 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 Immunology83 Microbiology84 Neurology85 Obstetrics and Gynecology86 Opthalmics87 Orthopedics88 Pathology89 Physical Medicine90 Radiology91 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 stdRC 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/scripts/cder/drls/default.cfm
References
www.registrarcorp.comhttp://www.fda.gov/forindustry/importprogram/
ucm349871.htmhttp://www.fda.gov/downloads/ForIndustry/
ImportProgram/UCM459926.pdfhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/
cfPCD/classification.cfmhttp://www.fda.gov/Drugs/InformationOnDrugs/
ucm142438.htmhttp://labels.fda.gov/
Foods/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 Food Safety Modernization Act (FSMA)
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 (Food Defense)
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 foodSome exemptions and modified requirements applyUpdated 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
Final Rule Due October 31
Voluntary Qualified Importer Program (“VQIP”)
Fast Lane for Food Imports
Expedited EntryExpedited Lab AnalysisDedicated Help Desk
Annual Fe: Estimated First Year Fee= $16,400.00
VQIP
When?Importers May Apply Annually January – MarchVQIP Year Runs From October to SeptemberFirst Year Anticipated to be 2018Which 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 ProgramFood CertificationsMay 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
www.registrarcorp.com
FDA UpdateFor Customs Brokers
And Importers
Presented by:
Cornelia Rooks , Senior Regulatory SpecialistRegistrar 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”)
•
•Tommy's rule of thumb...
•If it must be refrigerated
after opening, it probably requires a
process filing.
•Food Canning Establishment (FCE)•Low Acid and Acidified Foods (LACF)
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 MONOGRAPHSUnited 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 re-
registration (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 codeThe labeler code is used to configure the National Drug
Code (NDC) number10 digits (5-4-1 or 5-3-2) configurationUnique to the product and packagingThree 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
862 = Chemistry/Toxicology864 = Hematology/Pathology866 = Immunology/Microbiology868 = Anesthesiology870 = Cardiovascular872 = Dental874 = Ear, Nose and Throat876 = Gastro/Urology
878 = General Plastic Surgery880 = General Hospital882 = Neurological884 = Obstetrical/Gynecological886 = Ophthalmic888 = Orthopedic890 = Physical Medicine892 = Radiology
• Classification determines extent of regulatory control (Risk Based)
• 1700 generic groups of devices
• Classified within 16 medical specialties
21 CFR 862-892
CDRH Classification Panels
73 Anesthesiology74 Cardiovascular75 Chemistry76 Dental77 Ear, Nose and Throat78 Gastroenterology and
Urology79 General and Plastic Surgery80 General Hospital81 Hematology**Note: Used in Product Code
Builder
82 Immunology83 Microbiology84 Neurology85 Obstetrics and Gynecology86 Opthalmics87 Orthopedics88 Pathology89 Physical Medicine90 Radiology91 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 re-
registration (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
04/21/23
Activity Register ListPay 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
Manufacturer of components, that are not otherwise classified as a finished device, that are distributed only to a finished device manufacturer 807.65(a)
NO NO NO
04/21/23
Domestic Establishments
Activity Register ListPay 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
U.S. Manufacturer of export only devices 807.20(a)(2) YES YES YES
Manufacturer (including Kit Assemblers) 807.20(a) YES YES YES
04/21/23
Activity Register ListPay 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
Foreign EstablishmentsRequirements for Registration and Listing
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 Corp144 Research Drive, Hampton, Virginia USA 23666
P: +757-224-0177
F: +757-224-0179
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
www.registrarcorp.com