FDAInfo.com

Information ServicesUnited States2-10 Employees

Publishers of FDA compliance newsletters, manuals, CDs, and provider of full-text copies of 483s, EIRs, 510(k)s, PMA summaries and other FDA documents.

We publish:

*  Inspection Monitor
*  Validation Times
* Adverse Event Reporting News
* Warning Letter Bulletin

Compliance Manuals:

*  Guide to Vigilance & Adverse Event Reporting
*  Guide to Systems-based Inspections
*  483s/EIRs on CD and DVD
*  510(k)s and PMA summaries on DVD
*  FDA Computer Software Manual
*  Drug and Device Answer Book

Regulatory Documents:

Full text 483s, EIRs

Full text 510(k)s, 510(k) summaries

PMA summaries

And, more!

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