Import Alert 94-01
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(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).
Import Alert # 94-01
Published Date: 10/12/2011
Type: DWPE
Import Alert Name:
"Noncertified Television Receievers"
Reason for Alert:
CDRH is in receipt of numerous complaints of importers attempting to import uncertified and illegal multisystem television receivers. In addition, information has been received which suggests that these importers may be submitting false Customs and/or FDA import documents asserting that the merchandise consists of "electronic goods, radios, stereos, etc.," or falsely stating that the receivers are certified. The actual products may have "certification" labels that were not applied by the foreign firm or serial numbers and other identification information that may have been removed or replaced.
Television receivers introduced into U.S. commerce are subject to the Federal performance standard. Importers previously had been allowed to import certain noncertified receivers that were designated CCIR (Consultative Committee for International Radio) Standard 220 Volt receivers. Because these products originally would not accept the U.S. broadcast signal, and could not be readily used in the U.S., the policy was established that these products did not meet the applicability statement in the standard. Later as technology progressed, products known as "multisystem" televisions, which operate on either 220v or 120v electrical supplies, became available. Some models would accept the U.S. broadcast signals, and were determined to be subject to the standard and had to be distinguished from other multisystem receivers and detained.
Currently, all multisystem television receivers are considered capable of operating in the U.S. Such receivers offered for sale in the U.S. must be certified as meeting the performance standard and meet all other regulations applicable to television receivers before admission into the U.S.
Television receivers introduced into U.S. commerce are subject to the Federal performance standard. Importers previously had been allowed to import certain noncertified receivers that were designated CCIR (Consultative Committee for International Radio) Standard 220 Volt receivers. Because these products originally would not accept the U.S. broadcast signal, and could not be readily used in the U.S., the policy was established that these products did not meet the applicability statement in the standard. Later as technology progressed, products known as "multisystem" televisions, which operate on either 220v or 120v electrical supplies, became available. Some models would accept the U.S. broadcast signals, and were determined to be subject to the standard and had to be distinguished from other multisystem receivers and detained.
Currently, all multisystem television receivers are considered capable of operating in the U.S. Such receivers offered for sale in the U.S. must be certified as meeting the performance standard and meet all other regulations applicable to television receivers before admission into the U.S.
Guidance:
Districts may detain without physical examination all shipments of uncertified television receivers from the importers identified in the Red List for this alert.
The red List contains a list of importers who appear to be improperly entering multisystem television receivers. In addition, CDRH maintains a list of importers and foreign manufacturers believed to be involved in the importation of illegal television receivers.
For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at 301 796-6600.
The red List contains a list of importers who appear to be improperly entering multisystem television receivers. In addition, CDRH maintains a list of importers and foreign manufacturers believed to be involved in the importation of illegal television receivers.
For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at 301 796-6600.
Product Description:
Noncertified Multisystem Television Receivers
Charge:
The article is subject to refusal of admission pursuant to Section 536 of the Federal Food, Drug, and Cosmetic Act,(FD&C Act) Electronic Radiation Control Provisions, in that it appears to not comply with the requirements of 21 CFR 1020.10."
NOTE: Warning letters to importers may also cite the prohibited acts identified in Section 538 of the FD&C Act.
NOTE: Warning letters to importers may also cite the prohibited acts identified in Section 538 of the FD&C Act.
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