The medical device market is experiencing explosive growth. Currently valued at $90 billion, market growth will continue to accelerate as demographics and market drivers increase their pressure for new and innovative product offerings. Moreover, a substantial investment of time and resources is required to properly evaluate a new product idea and estimate its potential for success. So when a company executive declines a seemingly good product idea, what is probably being declined is the expense of properly evaluating the idea, and after having paid these expenses, the prospect of embarking on an expensive commercialization effort that has a 90 percent chance of failing.

1. Understanding the Regulatory Landscape.

3. FDA Structure / Organization FDA Structure / Organization Center for Veterinary Devices Food and Drug Administration Center for Biologics Evaluation and Research Center for Devices and Radiological Health National Center for Toxicological Research Center for Food Safety and Applied Nutrition Center for Drug Evaluation and Research Office of Combination Products

4. CDRH Offices Office of Device Evaluation Office of In-Vitro Diagnostic Devices & Safety Office of Health & Industry Programs Office of Science & Technology Office of Compliance Office of Surveillance & Biometrics Center for Devices and Radiological Health

7. FDA Premarket Submissions 3,635 4,247 4,320 510(k) 167 216 252 IDE amendment 9,879 4,415 242 29 10 666 54 FY03 9,064 10,323 Total 4,312 4,724 IDE supplement 226 312 Original IDE 29 16 HDE Supplement 9 5 Original HDE 635 645 PMA Supplement 51 49 Original PMA FY04 FY02 Type of Submission

8. FDA Medical Device User Fees FDA Fees FY2008 (Oct. 1, 2007 - Sept. 30, 2008) $185,000 $3,404 Standard Fee (U.S. Dollars) $46,250 PMA Submission $1,702 510(k) Submission Small Business Fee FY2008

30. What is a Combination Product? Stent Drug Stent Delivery System Polymer Slide courtesy of Nadine Ding, Guidant Corporation

31. Challenge of Combination Products CDRH CDER CBER NDA, BLA PMA, 510(K) IND, IDE Device Drug Biologic Different Frameworks Different Product Types Different FDA Reviews IND, NDA IDE, PMA, 510(k) IND, BLA CDER CDRH CBER Drug Device Biologic

32. Challenge of Combination Products Regulatory Complexity AERS GMP CBER / CDER BLA IND Biologic AERS GMP CDER NDA IND Drug MDR QSR CDRH PMA, 510(k) IDE Device Safety Reporting Quality System FDA Reviewing Center Approval Pre-Market Framework Product

33. Drug Eluting Stent System Design Slide courtesy of Nadine Ding, Guidant Corporation Drug Matrix Drug – polymer compatibility Loading capacity Release kinetics Pharmacology Polymer Chemistry Stent Tissue Mechanical scaffolding Mechanical Engineering Vascular Biology Coating integrity Vascular biology Tissue pharmacokinetics Preclinical models Vascular biology

36. Thank you For additional information contact: Medical Device Launchpad 800.525.0975