Getting started with a combination product: Part I

Medical Device and Diagnostic Industry

Volumn , Issue MAR., 2003, Pages

  Sall, Barry S ^a   Lassoff, Peter ^a   Babbitt, Bruce ^a  

^a PAREXEL INTERNATIONAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 70350398811     PISSN: 0194844X     EISSN: None     Source Type: Trade Journal    
DOI: None     Document Type: Article

References (6)

1. Intercenter Agreements, (Rockville, MD: FDA Office of Ombudsman); http://www. fda.gov/oc/ombudsman/pj.htm# intercenter, accessed December 6, 2002.
2. FDA Office of Ombudsman, Jurisdictional Updates; http://www.fda.gov/oc/ ombudsman/updates.html, accessed December 6, 2002.
3. FDA Office of Ombudsman, "Regulation of Combination Products: FDA Employee Perspectives, Combination Products Program;: http://www.fda.gov/oc/ ombudsman/rcpemployee.pdf, accessed December 6, 2002.
4. FDA Center for Devices and Radiological Health, "Information on the Medical Device User Fee and Modernization Act (MDUFMA) of 2002;" http://www.fda. gov/cdrh /mdufma/index html, accessed December 6, 2002.
5. ISO 10993-11001: Biological Evaluation of Madical Devices Part 1 : Evaluation and Testing, 2nd ed. (Geneva: International Organization for Standardization, 1997).
6. FDA Center for Drug Evaluation and Research, "International Conference of Harmonization Safety Guidances," ICH S1 - S7; http://www.fda.gov/cder/guidarice/ index.htm accessed December 6, 2002.