Import Alert 99-49

Import Alert # 99-49

Published Date: 03/26/2024

Type: DWPE

Detention Without Physical Examination of Devices Without a Unique Device Identifier and/or Matching GUDID Record

The label and package of every medical device must bear a Unique Device Identifier (UDI) that meets the requirements of 21 CFR part 801 subpart B and part 830 when required by 21 CFR 801.20. Additionally, under 21 CFR 830.300(a) and 830.320(b), for each version or model required to bear a UDI, the labeler must submit the information required by 21 CFR part 830 subpart E to FDA's Global Unique Device Identification Database (GUDID).

Devices listed on the Red List of this alert lack a required label and/or package that contains a UDI and/or lack a required GUDID record in the AccessGUDID database (https://accessgudid.nlm.nih.gov/).

Divisions may detain, without physical examination, shipments of the products identified on the Red List of this alert.

Recommendations for addition to Detention Without Physical Examination (DWPE) should be forwarded to the Division of Import Operations (DIO). Please include any relevant labeling, package inserts, user manuals, photographic evidence, website information, entry documents, and AccessGUDID records or similar information. The following types of devices should not be included:

a. A device used solely for research, teaching, or chemical analysis, and not intended for any clinical use.
b. Devices intended exclusively for use upon animals (non-human), check with the Center for Veterinary Medicine.
c. Custom devices.
d. Investigational devices.
e. Any device otherwise excepted from the requirements of 21 CFR part 801 subpart B under 21 CFR 801.30 or 801.128(f)(2).
f. Any class I device considered a consumer health product which bears a Universal Product Code. Consumer health product is defined in the Guidance for Industry and Food and Drug Administration Staff "Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices."
g. Any device which has been granted an exception from the requirements of 21 CFR part 801 subpart B under 21 CFR 801.55. (See https://www.fda.gov/medical-devices/unique-device-identification-system-udi-system/udi-exceptions-and-alternatives for a list of granted exceptions and alternatives).
h. Any device which has been granted an alternative to the requirements of 21 CFR part 801 subpart B under 21 CFR 801.55 and meets the requirements of the granted alternative. (See https://www.fda.gov/medical-devices/unique-device-identification-system-udi-system/udi-exceptions-and-alternatives for a list of granted exceptions and alternatives).

DIO will coordinate a review of all recommendations with FDA's Center for Device and Radiological Health (CDRH) Imports and Registration & Listing Team (IRLT).

For information about reconditioning, please refer to the FDA Regulatory Procedures Manual (RPM), Chapter 9, "9-12-Reconditioning."

For questions regarding device classification, please refer to the "FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act" guidance document: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-and-industry-procedures-section-513g-requests-information-under-federal-food-drug-and-cosmetic

RELEASE OF ARTICLES SUBJECT TO DETENTION WITHOUT PHYSICAL EXAMINATION UNDER THIS IMPORT ALERT:
In order to secure release of an individual shipment that is subject to detention without physical examination (DWPE) under this import alert, the owner, consignee and/or other responsible party should provide all relevant information supporting their request for release to FDA.

Information should be submitted to the FDA Division Compliance Office indicated in the 'Notice of FDA Action' notice of detention. Relevant information should pertain to the nature of the original violation and may include evidence such as revised labeling.

REMOVAL FROM DETENTION WITHOUT PHYSICAL EXAMINATION (REMOVE FROM RED LIST:
In order to remove a firm's product from the Red List of this Import Alert, information should be provided to the Agency to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of the violation. The purpose of this is so that the Agency will have confidence that future shipments will be in compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).

For further guidance on removal from detention without physical examination, refer to FDA's Regulatory Procedures Manual, Chapter 9, "9-8 Detention Without Physical Examination (DWPE)."

If a firm and/or representative thereof would like to petition for removal from detention without physical examination under this Import Alert, all relevant information supporting the request should be forwarded to the following address:

Food and Drug Administration
Division of Import Operations (DIO)
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857

Or via email: Importalerts2@fda.hhs.gov

DIO may coordinate the evaluation of a request for removal from detention without physical examination with CDRH Imports and Registration & Listing Team.

Questions or issues involving import operations should be addressed to the ORA/DIO,301-796-0356 or email fdaimportsinquiry@fda.hhs.gov

For questions concerning these types of devices or other compliance issues, should be addressed to the CDRH Imports and Registration & Listing Team via the CDRH Import Mailbox email address: cdrhimport@fda.hhs.gov

                                                                                                                                                          

Medical Devices

The article is a device that appears to be misbranded because its label or device package fails to bear a unique device identifier that meets the requirements of 21 CFR 801 subpart B and 21 CFR part 830, when required by 21 CFR 801.20. [Misbranding, Section 502(c)]

OASIS charge code: UDI LABEL

AND/OR

The article is a device that appears to be misbranded because there was a failure or refusal to electronically submit information required by 21 CFR part 830 subpart E, when required by 21 CFR 830.300(a) and 830.320(b). [Misbranding, Section 502(t)(2)]

OASIS charge code: GUDID

Desc: VIOLA THREADS PDO COGLYFT-MOLDING 19G 70MM USP 0 / 140MM

Notes: Misbranding, Section 502(c); Misbranding, Section 502(t)(2)

Desc: VIOLA THREADS PDO-COBRA COGLYFT 19G 100MM USP 0 / 200MM

Notes: Misbranding, Section 502(c); Misbranding, Section 502(t)(2)

Desc: VIOLA THREADS PDO-MULTI 23G 50MM USP 6-0 / 70MM

Notes: Misbranding, Section 502(c); Misbranding, Section 502(t)(2)