Good Manufacturing Practices (GMP) Guidelines: 2009 Edition, Version 2 (GUI-0001) [Health Canada, 2011] Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.
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Contact Information: Drug Good Manufacturing Practices Unit, Health Products and Food Branch Inspectorate Letter. 510(k) Clearances. Overview Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance.
This is known as Premarket Notification - also called PMN or 510(k). This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Engineering Standards, News and Resources for Engineers - ASME.