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Food and drug administration aplicadas a los cosméticos y los aparatos médicos

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Food and drug administration aplicadas a los cosméticos y los aparatos médicos

  1. 1. ProExport Colombia Trade Training Seminar Series May 2012U.S. Customs and U.S. FDA Import Requirements for Medical Devices & Cosmetics Presented by: Peter Quinter & Melissa Groisman Customs and International Trade Law Group, GrayRobinson Law Firm, Miami, Florida www.gray-robinson.com
  2. 2. Agenda• FDA Laws and Regulations• FDA Import Process• FDA Detentions (DWPE) and Refusals• FDA Import Alerts• U.S. Customs Liquidated Damages• Medical Devices• Cosmetics• Foodwww.gray-robinson.com 2
  3. 3. www.gray-robinson.com 3
  4. 4. Detention Process• The Food, Drug, and Cosmetic Act authorizes the FDA to detain a regulated product that “appears” to be out of compliance.• The FDA District Office will then issue a "Notice of FDA Action“ specifying the nature of the violation to the owner or importer.www.gray-robinson.com 4
  5. 5. Detention Without Physical Examination (DWPE)• Detention without physical examination, is appropriate when there exists a history of the importation of violative products, or products that may appear violative• Detention without physical examination properly places the responsibility for ensuring compliance with the law on the importerwww.gray-robinson.com 5
  6. 6. Notice of FDA Action #1• Products that appear (from examination or otherwise) to be violative may be detained and ultimately refused entry into the U.S.• Detention is permissible without actual observation of a product or its labeling.www.gray-robinson.com 6
  7. 7. Informal Hearing• The owner or importer is entitled to an informal hearing in order to provide testimony regarding the admissibility of the product.• "You have the right to provide oral or written testimony to the FDA, regarding the admissibility of the article(s) or the manner in which the article(s) can be brought into compliance."www.gray-robinson.com 7
  8. 8. Question• The U.S. importer has the right to provide oral or written testimony to the FDA regarding the admissibility of the article(s) or the manner in which the article(s) can be brought into compliance• True or false?www.gray-robinson.com 8
  9. 9. Conditional Release19 C.F.R. 141.113 - Food, drugs, devices, and cosmetics• For purposes of determining the admissibility of any food, drug, device, or cosmetic, the release from CBP custody of any such product will be deemed conditional.• The conditional release period will terminate upon the earliest occurring of the following events: 1. The date that FDA issues a notice of refusal of admission; 2. The date that FDA issues a notice that the merchandise may proceed; or 3. Upon the end of the 30-day period following the date of release.www.gray-robinson.com 9
  10. 10. Notice to Redeliver• "A request has been made to Customs to order redeliver for all the above product(s), in accordance with 19 CFR 141.113, which were conditionally released to you under terms of the entry bond. Failure to redeliver into Customs custody will result in a claim for liquidated damages under the provisions of the entry bond"www.gray-robinson.com 10
  11. 11. Entry Bond - Agreement to Redeliver Merchandise• § 113.62 Basic importation and entry bond conditions— A bond for basic importation and entry shall contain the conditions listed in this section and may be either a single entry or a continuous bond.(d) Agreement to Redeliver Merchandise.— If merchandise is released conditionally from Customs custody to the principal before all required evidence is produced, before its quantity and value are determined, or before its right of admission into the United States is determined, the principal agrees to redeliver timely, on demand by Customs, the merchandise released if it:(1) Fails to comply with the laws or regulations governing admission into the United States;(2) Must be examined, inspected, or appraised as required by 19 U.S.C. 1499;or(3) Must be marked with the country of origin as required by law or regulation. It is understood that any demand for redelivery will be made no later than 30 days after the date that the merchandise was released or 30 days after the end of the conditional release period (whichever is later). (See §§ 141.113(4 12.73(b)(2), and 12.80 of this chapter.)www.gray-robinson.com 11
  12. 12. 2nd Notice of FDA ActionIf the owner fails to submit evidence that the product is in compliance or fails to submit a plan to bring the product into compliance, FDA will issue another "Notice of FDA Action“ Refusing admission of the product.www.gray-robinson.com 12
  13. 13. Final Notice FDA Action• Subject: NO LOCATION RECEIVED"You have been previously notified that this shipment is to be held intact for FDA examination and/or sampling. You have not advised us of the status or location of the lot represented by the referenced entry number. A written release from FDA is required before moving your goods in domesticwww.gray-robinson.com 13
  14. 14. Notice of Refusal• The following products are subject to refusal pursuant to the Federal Food Drug and Cosmetic Act in that they appear to be adulterated misbranded or otherwise in violation.www.gray-robinson.com 14
  15. 15. Refusal• The product then has to be exported or destroyed within 90 days otherwise subject to Liquidated Damages.• Failure to do so may result in destruction of the products.• Distribution of the products may result in their seizure and/or injunction or criminal prosecution of persons responsible for their distribution .www.gray-robinson.com 15
  16. 16. Import Alert• Import Alert # 12-10, May 25, 2012 (Cheese due to microbiological contamination)• Import Alert #53-06, May 25, 2012 (cosmetics containing illegal colors)ished Date: 8/9/2010• Green List v. Red Listwww.gray-robinson.com 16
  17. 17. Import Alert Example• Import Alert # 16-81• Published Date: 05/13/2010• Type: DWPE (Detention Without Physical Examination)• Import Alert Name:• — "Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella"• Reason for Alert: Division of Import Operations and Policy has received recommendations from districts for detention without physical examination of seafood products due to Salmonella contamination from specific manufacturers/shippers. This import alert has been developed for seafood products from firms/countries which do not readily fit into previously existing import alerts.www.gray-robinson.com 17
  18. 18. Removal from Import Alert List• FDAs Regulatory Procedures Manual – Ch. 9 - Import Operations And Actions • 9-6 Detention without Physical• Examination (DWPE) – http://www.fda.gov/ICECI/ComplianceManuals/Rwww.gray-robinson.com 18
  19. 19. Removal from Import Alert List• FDAs Regulatory Procedures Manual provides guidance to those who wish to get off the Import Alert list.• Generally, one would need: – A minimum of five consecutive non-violative commercial shipments must enter the U.S., – At least one of the five non-violative entries should be audited by the FDA to ensure compliance. – The five shipments must be over a reasonable time period, not one day. – A Petition must be filed with the FDA requesting that the importer be removed from the automatic detention list.www.gray-robinson.com 19
  20. 20. Entry Bond - Consequence of Default• § 113.62 Basic importation and entry bond conditions. – (m) Consequence of default. • (1) If the principal defaults on agreements in this condition ... the obligors agree to pay liquidated damages equal to the value of the merchandise involved in the default, or three times the value of the merchandise involved in the default if the merchandise is restricted or prohibited merchandise ...www.gray-robinson.com 20
  21. 21. CBP Form 301 Customs Bondwww.gray-robinson.com 21
  22. 22. Liquidated Damages Claim• In accordance with 19 C.F.R. 141.113 – Redelivery Notice (date) – Redelivery Required (date) – "Described merchandise not redelivered into Customs custody after refused admission by the FDA" – "Failure to comply with a demand for redelivery... will result in the assessment of liquidated damages equal to three times the value of the merchandise..."www.gray-robinson.com 22
  23. 23. Liquidated Damage Claim• The provisions of 21 C.F.R. 1.97 require that Customs and FDA agree about the amount to cancel the claim for liquidated damages.• All Petitions for relief received by Customs in FDA cases must be referred to FDA for recommendation.• With few exceptions, Customs must follow the recommendation of FDA.www.gray-robinson.com 23
  24. 24. Cosmetic Labeling• It is illegal to introduce a misbranded cosmetic into interstate commerce, and such products are subject to FDA action.• Some of the ways a cosmetic can become misbranded are: – labeling is false or misleading – label fails to provide required information – required label information is not properly displayedwww.gray-robinson.com 24
  25. 25. Labeling Terms• Labeling. This term refers to all labels and other written, printed, or graphic matter on or accompanying a product• Principal Display Panel (PDP). This is the part of the label most likely displayed or examined under customary conditions of display for sale• Information Panel. Generally, this term refers to a panel other than the PDP that can accommodate label information where the consumer is likely to see it. The information must be prominently and conspicuously displayed.www.gray-robinson.com 25
  26. 26. Required Label Information• An identity statement, indicating the nature and use of the product, by means of either the common or usual name, a descriptive name, a fanciful name understood by the public, or an illustration• An accurate statement of the net quantity of contents, in terms of weight, measure, numerical count or a combination of numerical count and weight or measure The following information must appear on an information panel.• Name and place of business. This may be the manufacturer, packer, or distributor.• Distributor statement. If the name and address are not those of the manufacturer, the label must say "Manufactured for..." or "Distributed by..."• Material facts. Failure to reveal material facts is one form of misleading labeling and therefore makes a product misbranded. An example is directions for safe use, if a product could be unsafe if used incorrectly.• Warning and caution statements. Cosmetics that may be hazardous to consumers must bear appropriate label warnings. Flammable cosmetics are an example.• Ingredients. If the product is marketed on a retail basis to consumers, even it it is labeled "For professional use only" or words to that effect, the ingredients must appear on an information panel, in descending order of predominance. www.gray-robinson.com 26
  27. 27. • All required labeling information must be in English• It is not permitted to label cosmetics "FDA Approved“. As part of the prohibition against false or misleading information, no cosmetic may be labeled or advertised with statements suggesting that FDA has approved the product.• False or misleading statements on labeling make a cosmetic misbranded. www.gray-robinson.com 27
  28. 28. Anti-Aging Creams• Import Alert # 66-38 Published Date: 03/27/2012• "Skin Care Products Labeled As Anti-Aging Creams"• There are numerous skin care products on the market with exaggerated "anti aging" claims which cause the products to be unapproved new drugs.• Examples of such claims are that the products "counteract," "retard," or "control" the aging process. Claims that the product will "rejuvenate," "repair," or "restructure" the skin may also be drug claims.www.gray-robinson.com 28
  29. 29. Voluntary Cosmetic Registration Program• FDA Form 2511 - Registration of Cosmetic Product Establishment• FDA Form FDA 2512 - Cosmetic Product Ingredient Statement (CPIS)www.gray-robinson.com 29
  30. 30. What is a Medical Device?• The term "device" means an instrument, apparatus, implement, machine, implant, or other similar or related article…which is: – recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them, – 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….www.gray-robinson.com 30
  31. 31. Which of the following products is NOT a medical device?• Dental Floss• Lipstick• Eyeglasses• Pacemakerwww.gray-robinson.com 31
  32. 32. What is a Medical Device?Examples of Medical Devices:• Pacemakers• Contact Lenses• Hearing Aids• Dental Floss• Thermometerwww.gray-robinson.com 32
  33. 33. Federal Food, Drug and Cosmetic ActImported medical devices must fullycomply with the Act before the device isreleased by U.S. Customs into the UnitedStates.www.gray-robinson.com 33
  34. 34. Medical Device Import Alert• Import Alert # 89-16 Published Date: 03/13/2012• Detention Without Physical Examination of Products from Medical Device Firms Refusing FDA Foreign Establishment Inspection• The FDA often conducts establishment inspections of foreign manufacturers who produce FDA-regulated articles intended for sale in the US. As part of this inspection process, FDA may contact the foreign manufacturer and schedule the establishment inspection. If a manufacturer who offers devices for import into the United States refuses to permit or allow the completion of an FDA inspection of the foreign facility, it will be assumed that the methods and controls used for the design, manufacture, packaging, labeling, storage, installation, or servicing of any devices produced at such facility do not conform to the U.S. requirements, and that the devices manufactured at that facility are considered to be “adulterated”. They will be refused entry into the United States. www.gray-robinson.com 34
  35. 35. Checklist To Import Medical Devices• Premarket Notification (510(k)), unless exempt, or Premarket Approval (PMA)• Establishment Registration on Form FDA-2891• Device Listing on Form FDA-2892• Quality System Regulation (QSR) (sometimes referred to as good manufacturing practices or GMPs)• Labeling Requirements• U.S. Designated Agent (for imported devices)www.gray-robinson.com 35
  36. 36. Medical Devices Classes The class to which your device is assigned determines, among other things, the type of premarket submission or application required for FDA clearance to sell the device.www.gray-robinson.com 36
  37. 37. Medical Devices Classes• CLASS I most are exempt from Premarket Notification• CLASS II most require a Premarket Notification• Most Class I devices and some Class II devices are exempt from 510(k) submission. A list of exempt devices is located at:www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm• CLASS III those that support or sustain human life, most require a Premarket Approval (PMA)www.gray-robinson.com 37
  38. 38. DUE DILIGENCE• Does the foreign manufacturer, and initial importer or distributor have a current Establishment Registration?• Check FDA Website:http:// www.accessdata.fda.gov/scripts/cder/drls/dwww.gray-robinson.com 38
  39. 39. www.gray-robinson.com 39
  40. 40. DUE DILIGENCE -- U.S. Agent• Cualquier establecimiento extranjero que se dedica a la producción, preparación, distribución, combinación o procesamiento de dispositivos importados a los Estados Unidos debe identificar a un agente en Estados Unidos (agente estadounidense) para tal establecimiento.• Information on U.S. Agents can be found at (en español):• http://www.fda.gov/MedicalDevices/DeviceRegulationandwww.gray-robinson.com 40
  41. 41. Responsabilidades de un agente estadounidense• El agente estadounidense debe, ya sea residir en EE.UU. o contar con un espacio comercial en EE.UU. El agente estadounidense no puede utilizar una casilla de correo postal como dirección. El agente estadounidense no puede utilizar simplemente un servicio de respuesta. Deben estar disponibles para responder llamadas telefónicas o contar con un empleado disponible para responder llamados telefónicos durante el horario comercial normal.• Las responsabilidades del agente estadounidense son limitadas e incluyen:• asesorar a la FDA en comunicaciones con el establecimiento extranjero,• responder preguntas relacionadas con los dispositivos de establecimiento extranjeros que son importados u ofrecidos para importación a los Estados Unidos.• asesorar a la FDA en la coordinación de inspecciones a los establecimientos extranjeros y• si la FDA no puede contactar al establecimiento extranjero directa o rápidamente, la FDA puede suministrar información o documentos al agente estadounidense y tal acción será considerada equivalente a proporcionar la misma información o documentos al establecimiento extranjerowww.gray-robinson.com 41
  42. 42. Questionswww.gray-robinson.com 42
  43. 43. ProExport Colombia Trade Training Seminar Series May 2012U.S. Customs and U.S. FDA Import Requirements for Medical Devices & Cosmetics Presented by: Peter Quinter & Melissa Groisman Customs and International Trade Law Group, GrayRobinson Law Firm, Miami, Florida www.gray-robinson.com