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Articles by Category - Regulatory Affairs

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• (Regulations & Standards) A New Genetic Panel for FDA, Russel Enns (IVDT, Nov 99, p. 26). Keyword: MDAC.
• (Regulations & Standards) Europe's IVD Directive: More (and Less) than Meets the Eye, Maurizio Suppo (IVDT, Sep 99, p. 26). Keyword: Europe.
• (News) FDA Labeling Guidance Gets Mixed Reviews (IVDT, Sep 99, p. 18). Keyword: Labeling.
• (Regulations & Standards) Labeling for IVDs: Issues and Recommendations, Patricia Shrader (IVDT, Jul 99, p. 28). Keyword: Labeling.
• (News) CLIA Complexity Goes to ODE (IVDT, Jul 99, p. 18). Keyword: CLIA.
• Regulatory Options for IVDs—Selecting the Best Path to Market, Jeffrey Gibbs (IVDT, Mar 99, p. 28).
• (Commentary) Europe's IVD Directive—More Work for Diagnostics Manufacturers, John Place (IVDT, Mar 99, p. 24). Keywords: IVD Directive.
• EU Starts Five-Year Countdown for the IVD Directive, Maurizio Suppo (IVDT, Jan 99, p. 18). Keywords: IVD Directive.

• (Regulations and Standards) Free-Speech Decision Could Advance Off-Label IVD Promotion, Jeffrey Gibbs (IVDT, Nov 98, p. 22). Keywords: Off-label use.
• (Editor's Page) And another thing..., Steve Halasey (IVDT, Nov 98, p. 8). Keywords: Design Control.
• Regulations and Standards: FDA Makes a Better Rule for IHCs, Jeffrey N. Gibbs (IVDT, Sep 98, p. 25). Keyword: immunohistochemicals.
• Editor's Page: Pass the Torch, Please, Steve Halasey (IVDT, Sep 98, p. 8). Keyword: CLIA.
• Regulations and Standards: CLIA reform: Present and future, Bradley Thompson (IVDT, May 98, p. 24).
• (News) European BSE talks collapse (IVDT, May 98, p. 16).
• (News) FDA joint panel weighs uses of gold standards, Steven Halasey (IVDT, May 98, p. 12).
• Regulations and Standards: FDA's RUO/IUO Policy: A small step, Jeffrey N. Gibbs (IVDT, Mar 98, p. 27).
• (News) IVD logic prevails over BSE ban (IVDT, Mar 98, p. 22).
• (News) Manufacturers cry foul over classification of dengue (IVDT, Mar 98, p. 22).
• Regulations and Standards: ASRs: FDA issues final rule, Jeffrey N. Gibbs (IVDT, Jan 98, p. 28).
• Commentary: All that glitters is not a gold standard, Roger Briden (IVDT, Jan 98, p. 24).
• (News) DCLD to post reclassification list on Web (IVDT, Jan 98, p. 22).
• Sense and sensitivity, Steven Halasey (IVDT, Jan 98, p. 8).

• The changing regulatory climate for blood establishments and their vendors, David F. Weeda (IVDT, Nov 97, p. 22).
• HIMA urges reform of Japanese IVD regs (IVDT, Nov 97, p. 14).
• (News) BSE scare threatens IVD manufacturers (IVDT, Nov 97, p. 12).
• (News) NCCLS issues test guidelines (IVDT, Sep 97, p. 22).
• (News) FDA advisory notices (IVDT, Sep 97, p. 20).
• Border-line mentality, Steven Halasey (IVDT, Sep 97, p. 8).
• GMP inspectional consistency: A plan for the future, Leif Olsen (IVDT, Mar 97, p. 50).
• Coming of electronic age at DCLD, Janice Kates (IVDT, Mar 97, p. 36).
• Commentary: Ethics of IVD use are outside FDA jurisdiction, Glen Freiberg (IVDT, Mar 97, p. 20).
• Communicating best practices, Steven Halasey (IVDT, Mar 97, p. 8).
• GMP inspectional consistency: Industry comes forward, Leif Olsen (IVDT, Jan 97, p. 44).

• Triage for clinical laboratory devices, Ed Kimmelman (IVDT, Nov 96, p. 34).
• (News) FDA investigates IgM tests for toxoplasmosis (IVDT, Nov 96, p. 8).
• Commentary: FDA's view on safety, efficacy, and submission review times, Joseph Hackett (IVDT, Sep 96, p. 24).
• (News) FDA branch chief says strep A antigen tests are OK (IVDT, Sep 96, p. 16).
• (News) FDA says new product label information is likely for current group B strep antigen tests (IVDT, Sep 96, p. 12).
• If a tree falls in the forest . . ., Jenevieve Blair Polin (IVDT, Jul 96, p. 6).
• (News) Proposed reclassification of analyte-specific reagents (IVDT, May 96, p. 17).

• Commentary: A Proposed Change to the Regulation of Serum Tumor Markers, Chris Zalesky (IVDT, Nov 95, p. 8).
• Adaptation for survival, Jenevieve Blair Polin (IVDT, Nov 95, p. 6).
• (News) FDA and industry cooperate to develop new reagent draft guidance (IVDT, Sep 95, p. 12).
• (News) FDA and industry reps square off at roundtable (IVDT, Sep 95, p. 11).
• O brave new IVD customer, Jenevieve Blair Polin (IVDT, Sep 95, p. 6).
• Clinical feasibility studies: Results pinpoint parameters for pivotal studies, Katie Smith (IVDT, Jul 95, p. 26).
• (News) CLIA advisory committee gets progress report (IVDT, Jul 95, p. 16).
• Commentary: IRB approval for IVD clinical trials: An unnecessary burden, Jeffrey Gibbs (IVDT, Apr 95, p. 5).
• Good science meets good business, Jenevieve Blair Polin (IVDT, Feb 95, p. 4).

• (Regulations and Standards) Academic training for regulatory affairs professionals, Larry Gundersen (IVDT, Apr 02, p. 20). Keyword: Industry.
• (Industry News) EDMA issues final EU market figures, Richard Park (IVDT, Mar 02, p. 16).

• Regulations and standards, Jeffery Gibbs (IVDT, Nov 01, p. 22). Keyword: FDA.
• (Regulations and standards) Toward a standards-based future: ISO TC 212 standards update, Donald Powers (IVDT, Jul 01, p. 22). Keyword: Standards.
• (Regulations & Standards) The European Union’s IVD Directive, Francesco Dati (IVDT, Apr 01, p. 22).

• (Regulations and Standards) IVDs and the states: The other regulatory system, Jeffrey Gibbs (IVDT, Sep 00, p. 30). Keyword: FDA.
• (Regulations and Standards) Traceability of Assay Calibrators: The EU's IVD Directive Raises The Bar, Donald Powers (IVDT, Jul 00, p. 26). Keyword: Standards.
• (Commentary) Labeling for IVDs: Symbols To Meet The Needs Of A Multilingual Market, Carolyn Jones (IVDT, Jul 00, p. 23).
• (Regulations & Standards) FDA takes over CLIA complexity determinations, Joseph Hackett (IVDT, May 00, p. 26). Keywords: CLIA, FDA.
• (Regulations & Standards) Human Tissue Acquisition: New Regulatory and Ethical Issues, Jeffrey Gibbs (IVDT, Mar 00, p. 22). Keywords: Human Tissue.
• (Regulations & Standards) Device reforms at CBER: Enough or Too Much?, Stephen Northrup (IVDT, Jan 00, p. 24). Keyword: CBER.