Import Alert 57-20

(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 # 57-20
Published Date: 10/04/2023
Type: DWPE

Import Alert Name:

"Imported Dura Mater Regulated Under Section 361 Of The Public Health Service Act (PHS Act)"

Reason for Alert:

Note: The revision of this Import Alert (IA) dated 10/4/2023 updates the title, alert subtype to country/ worldwide, reason for alert section, guidance section, agency contacts, product description, and screening Changes to the import alert are bracketed by asterisks (***).

***Dura mater imported for human implantation is regulated as an HCT/P under section 361 of the PHS Act and the implementing regulations 21 CFR Part 1271. Dura Mater is closely associated with the central nervous system and is considered a public health concern since it may transmit some human transmissible spongiform encephalopathies (TSEs) such as CJD and vCJD. Currently, FDA does not recommend testing for human TSEs such as CJD and vCJD and there are no FDA-approved donor screening tests for prions.***

However, manufacturers must screen donors of dura mater by reviewing the donor's relevant medical records for risk factors for and clinical evidence of TSE, including vCJD and CJD ((§ 1271.75(a)). Such factors include residence in a country where there is a geographic risk of BSE and, related, vCJD. In addition, manufacturers must perform an adequate assessment for donors of dura mater to detect evidence of TSE (§ 1271.85(e)).

Guidance:

***Divisions may detain without physical examination all imported Dura Mater due to the possible risk of CJD and vCJD transmission.

Divisions should request documents to determine if entries of dura mater are imported from a country of geographical risk of BSE (See the updated list below for your reference) or are imported following transshipment from a country of geographical risk of BSE.

When Dura mater is verified to have been directly imported from a country of geographical risk of BSE or imported following transshipment from a country of geographical risk of BSE, it may be refused entry.

Divisions encountering Dura Mater that is not directly imported from a country of geographical risk of BSE or imported following transshipment from a country of geographical risk of BSE should contact CBER's Office of Compliance and Biologics Quality, Division of Case Management (OCBQ/DCM) to determine admissibility.

Dura Mater or HCT/Ps imported for veterinary use and/or research purposes are not covered by this import alert. Blood and/or blood products are not considered HCT/Ps and therefore are not covered by this import alert.

Countries List Based on Geographic Risk of BSE:

Albania(AL), Andorra (AD), Austria(AT), Belgium(BE), Bosnia-Herzegovina (BA), Bulgaria(BG), Croatia(HR), Czech Republic(CZ), Denmark(DK), Finland(FI), France(FR), Germany(DE), Greece (GR), Hungary(HU), Ireland(IE),Israel(IL), Italy(IT), Japan (JP), Liechtenstein (LI), Luxembourg(LU), Macedonia(MK), Monaco (MC), Netherlands(NL), Norway(NO), Oman (OM), Poland(PL), Portugal(PT), Romania(RO), San Marino(SM), Slovak Republic(SK), Slovenia(SI), Spain(ES), Sweden(SE), Switzerland(CH) and United Kingdom (GB).

Release of Articles Subject to Detention Without Physical Examination Under this Import Alert:

In order to secure release of an individual shipment subject to DWPE under this Import Alert, the importer and/or another responsible party to the shipment should provide evidence that the shipment does not contain imported Dura Mater Regulated as Human cells, tissues, or cellular and tissue-based products (HCT/Ps) Under Section 361 of the Public Health Service Act (PHS Act). If needed, CBER's Office of Compliance and Biologics Quality, Division of Case Management will evaluate on a case-by-case basis.

Questions or issues involving import operations should be addressed to ORA/DIO (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov.

For questions regarding these criteria and/or products covered, contact CBER's Office of Compliance and Biologics Quality, Division of Case Management at CBERImportInquiry@fda.hhs.gov or by phone at 240-402-9156.

                                                                                                                                                                ***

Product Description:

Dura Mater

Charge:

This human cell, tissue, and cellular and tissue-based product is in violation of Section 361 of the Public Health Service Act.

OASIS charge code: TISSUE

Countries

MULTIPLE COUNTRIES

  • (57 T - - 01) Dura Mater
    Desc: Human Dura Mater
  • (84 L - - EM) Dura Mater, Human, Lyophilized
    Desc: Dura Mater Human Lyophilized