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Strategic planning for U.S. premarket approval submissions.
| Content Provider | Semantic Scholar |
|---|---|
| Author | Donawa, Maria E. |
| Copyright Year | 2006 |
| Abstract | The United States premarket approval (PMA) process is costly and time-consuming and differs in important ways from the CE-marking process. This article discusses the importance of strategic planning for submission of a PMA and the issues that should be considered, which can lead to a reduction in the time and cost involved. |
| File Format | PDF HTM / HTML |
| PubMed reference number | 17039953 |
| Journal | Medline |
| Volume Number | 17 |
| Issue Number | 7 |
| Alternate Webpage(s) | http://www.donawa.com/donawa/files/6%20PMAs%20Sep2006%20MDT%20issue.pdf |
| Journal | Medical device technology |
| Language | English |
| Access Restriction | Open |
| Content Type | Text |
| Resource Type | Article |