1 / 13

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).

fay
Télécharger la présentation

Presented by 612 492 7336 rklepinski@fredlaw.com

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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

More Related