Published Online
on May 3, 2007

A more recent version of this article appeared on June 1, 2007

This Article Full Text (PDF) All Versions of this Article: 38/6/1737    most recent STROKEAHA.106.478172v1 Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Request Permissions Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Goldstein, L. B. Search for Related Content PubMed PubMed Citation Articles by Goldstein, L. B. Pubmed/NCBI databases Medline Plus Health Information Stroke Related Collections Other Ethics and Policy Related Article

Regulatory Device Approval for Stroke. Fair and Balanced?

Larry B. Goldstein MD^*

From the Duke Center for Cerebrovascular Disease, Center for Clinical Health Policy Research, Duke University, and Durham VA Medical Center, Durham, NC.

^* To whom correspondence should be addressed. E-mail: golds004{at}mc.duke.edu.

Key words: stroke • therapy • FDA • regulatory requirements

Related Article:

An Example of US Food and Drug Administration Device Regulation: Medical Devices Indicated for Use in Acute Ischemic Stroke

Carlos Peña, Khan Li, Richard Felten, Neil Ogden, and Mark Melkerson
Stroke 2007 38: 1988-1992. [Abstract] [Full Text] [PDF]