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Presented by 612 492 7336 rklepinski@fredlaw.com

Ace Medical Promotion. Presented by 612 492 7336 rklepinski@fredlaw.com. Bob Klepinski. Ace Promotion before Clearance/Approval. There are basic differences in promotion of 510(k) vs. PMA devices FDA jurisdiction is different and policies/guidance differ. 510(k).

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Presented by 612 492 7336 rklepinski@fredlaw.com

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  1. Ace Medical Promotion Presented by 612 492 7336 rklepinski@fredlaw.com Bob Klepinski

  2. Ace Promotion before Clearance/Approval • There are basic differences in promotion of 510(k) vs. PMA devices • FDA jurisdiction is different and policies/guidance differ

  3. 510(k) • 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”

  4. Claims for 510(k) Products • 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

  5. Pre-Clearance • 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

  6. Pediatric Claims • 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

  7. PMA Products • 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?

  8. Tools • For the PMA product, Ace should be using the available tools that FDA guidance and policy have provided, e.g. • Press Release • Notice of Availability Ads • CME conferences • Distribution of peer-reviewed articles

  9. Press Releases • 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

  10. Ads • Any ads for the PMA product before release should follow the Notice of Availability guidance • No claims that the device is safe or effective

  11. Trade Shows • 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

  12. Summary • 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

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