1. Development Cycle of Medical Devices: A Path of Opportunities for Information Professionals Donna Gay Pharma & Health Tech Div, SLA 2007 Spring Meeting – Boston March 19, 2007

2. What is a Medical Device ?

3. From section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act: From section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act: "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

4. recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or ~ from section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act

5. intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes." ~ from section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act

6. Examples Examples

7. Background CDRH - Center for Devices & Radiological Health CFR 21, Parts 800-1299 Device classifications: I, II, III

8. Medical Device Development Path

9. Project Initiation

10. Project Chartering

11. Launch IDE PMA 510(k)

12. Transition

13. Questions

14. Thank You for coming and Thanks to my J&J Colleague, Rengin Konuk of Ethicon for her assistance.