1. Executive Director, Registrar Corp
FDA BASICS November 2016
Russell K. Statman
Executive Director, Registrar Corp
144 Research Drive
Hampton, Virginia USA 23666 1 1

2. The Goal Clear U.S. Customs and U.S. FDA without detention
Conduct Business in the USA Profitably and Competitively 2

3. PREDICT
PREDICT establishes a risk score by analyzing shipment information according to FDA-developed risk criteria, including exporter and manufacturer compliance history, product risk, etc.
Word to the Wise:
The Best Way to Stay Out of Trouble with FDA
is To Stay Out of Trouble With FDA! 3 3 3

4. First Advice 4 4

5. Products Regulated by the FDA
Food and Beverages
Dietary Supplements
Food additives and food contact substances
Drugs and Biologics
Cosmetics
Medical Devices
Radiation Emitting Devices
Tobacco 5 5 5

6. Background
Basic Requirements 6 6 6

7. FOOD
Facilities must be registered with FDA biennially, with Designation of “US Agent” and Consent to Inspection
Food must be labeled properly-New Rules!!!!!
Compliance Date: 26 July 2018 for > $10M
Compliance Date: 26 July 2019 for < $10M
Good Manufacturing Practices and FSMA
For shelf-stable, sealed foods, “FCE” registration and process filing may be required
Prior Notice Before Each Entry of Imported Food 7 7

8. Drugs Establishments must be registered with FDA
Drugs must be listed with FDA
Drugs must be labeled properly
Good Manufacturing Practices must be followed
Drugs must not be “Adulterated” 8 8 8

9. DRUGS *Some exception exist for “grandfathered” drugs, research, etc.
Manufacturing, Labeling, Distributing, and Promoting Drugs Must:
Follow the “ Drug Monograph” for that drug OR
Follow an approved “New Drug Application” (NDA)
*Some exception exist for “grandfathered” drugs, research, etc. 9 9

10. Cosmetics Must be labeled properly Good Manufacturing Practices
Colors and Ingredients Are Regulated and Frequently Cause Detentions and Refusals
*Registration of Cosmetic Establishments and filing of Cosmetic Product Ingredient Statements are voluntary. 10 10 10

11. Medical Devices Establishments must be registered with FDA
Devices must be listed with FDA and label with GUDID
Devices must be labeled properly (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 11 11 11

12. Identifying the Product in the FDA World
The intended use of a product determines whether it is a “Drug,” a “Cosmetic,” or both.
The intended use of a product determines whether it is a “Medical Device” and how it is classified as a Medical Device.
The intended use of a product determines whether it is a “Drug” or a “Dietary Supplement.” 12 12 12

13. 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 13 13 13

14. Label Labeling 14 14 14

15. 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”
Cosmetic – an article intended to be “applied to the human body… for cleansing, beatifying, promoting attractiveness, or altering the appearance” 15 15 15

16. Drug Cosmetic
Source:
Source: 16 16 16

17. 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”
Dietary supplement - a product taken by mouth that contains a "dietary ingredient" intended to supplement the diet. 17 17 17

18. Medical Devices
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. 18 18 18

19. Radiation Emitting Devices
All REDs must designate a U.S. Agent for service of process
Product Reports
Annual Reports
“Accession Number”
Form 2877 19 19 19

20. Summary of FDA registration and listing requirements
Food (human and animal) - FFR, FCE, SID
Drugs (human and animal)- Establishment Registration, listing
Medical Devices (human only) – Establishment registration, listing, GUDID registration
Cosmetics – No registration or listing requirements but may be deemed a drug by “labeling” – watch colors and ingredients!
Radiation-Emitting Devices – Product Reports, Annual Reports, “Accession number” Performance Standards Form 2877 20 20

21. DETENTION WITHOUT PHYSICAL EXAMINATION
IMPORT ALERTS:
DETENTION WITHOUT PHYSICAL EXAMINATION 21

22. Detention without Physical Examination (“DWPE”)
Green lists
Red lists
Yellow Lists
Removal from Import Alert 22

23. FDA Detention “Notice of Action” Sampling
Opportunity to Present “Testimony”
Reconditioning (Form 766)
Release or Refusal
Released “with comment”
Re-Export or Destruction
“Redelivery” 23

24. NOTICE OF ACTION 24

25. “Notice of FDA Action” Issued by FDA and sent to two parties:
Importer of Record
Customs Broker
Time sensitive with a
respond by deadline 25 25 25

26. Final Advice 26 26

27. Registrar Corp Headquarters
Questions?
Registrar Corp Headquarters
144 Research Drive
Hampton, Virginia
USA 23666 P: F: E: 27 27

28. Registrar Corp Worldwide Offices28 28