2. ©2007 Fredrikson & Byron P.A. Presented by 612 492 7336 rklepinski@fredlaw.com

3. ©2007 Fredrikson & Byron P.A. There are basic differences in promotion of 510(k) vs. PMA devices FDA jurisdiction is different and policies/guidance differ

4. ©2007 Fredrikson & Byron P.A. The Food, Drug, and Cosmetic Act (FDCA) does not give FDA authority over ads for devices that are not “restricted” Most 510(k) products are not restricted This is why FDA calls all materials for 510(k) devices “labeling”

5. ©2007 Fredrikson & Byron P.A. Because the major control is over labeling, FDA focuses its compliance actions on whether a claim is outside the indications for use in the clearance

6. ©2007 Fredrikson & Byron P.A. Despite FDA’s wishes to control statements outside a clearance, FDA has issued guidance indicating that it is acceptable to display and advertise 510(k) devices before clearance You need to state it’s regulatory status You cannot take orders or offer to take orders

7. ©2007 Fredrikson & Byron P.A. If Ace had simply promoted off label for pediatric use, FDA would most likely have viewed it as promoting an indication for which the device was not cleared By filing a 510(k), Ace can use the guidance concerning promotion of a new device before clearance

8. ©2007 Fredrikson & Byron P.A. CDRH views PMA products in much the same manner as CDER views drugs No promotion before approval This is not explicit in the FDCA FDA is saying it is inherently false or misleading to promote a PMA device before approval This blanket approach is clearly, absolutely unconstitutional, but who among us wants to bring the case?

9. ©2007 Fredrikson & Byron P.A. For the PMA product, Ace should be using the available tools that FDA guidance and policy have provided, e.g. 1.Press Release 2.Notice of Availability Ads 3.CME conferences 4.Distribution of peer-reviewed articles

10. ©2007 Fredrikson & Byron P.A. This is a common exception to FDA promotional rules SEC and other agencies require that material information be disseminated (and disseminated equally) FDA recognizes this need and allows truthful statements that they would otherwise object to in promotional material

11. ©2007 Fredrikson & Byron P.A. Any ads for the PMA product before release should follow the Notice of Availability guidance No claims that the device is safe or effective

12. ©2007 Fredrikson & Byron P.A. Display of the unapproved product is acceptable at trade shows PMA products should follow the Notice of Availability guidance 510(k) products should have a statement that the 510(k) is pending, or equivalent

13. ©2007 Fredrikson & Byron P.A. If done following guidance, most of these activities may be done without FDA concern It would be really easy to do them in a manner that FDA would view as entirely illegal