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

Human cells, tissues, and cellular and tissue-based products (HCT/Ps), particularly HCT/Ps such as dura mater that are closely associated with the central nervous system, 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.

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)).

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

1. Districts may request documents to determine if entries of dura mater are:

a. Imported from a country of geographical risk of BSE (See the updated list below for your reference);

b. Imported following transshipment from a country of geographical risk of BSE.

2. Dura mater that is directly imported from a country of geographical risk of BSE or imported following transshipment from a country of geographical risk of BSE may be refused entry.

3. Districts 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 OCBQ/DCM, Import/Export Staff to determine admissibility.

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), United Kingdom (GB), and Yugoslavia(YU).

Dura Mater

"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