FDA's New Refuse To Accept (RTA) Guidance: What You Need To Know

Last month, the FDA quietly finalized a new guidance that is likely applicable to the majority of Med Device Online’s audience. The guidance, which goes into effect on October 1, spells out the agency’s latest thinking on its Refuse to Accept Policy for 510(k) submissions, more commonly known as RTA. It was curious timing for a guidance on this topic, given that FDA subsequently announced that RTA rates have been cut by nearly 40 percent over the past two years.

In this podcast, Michael Drues, Ph.D., president of Vascular Sciences and author of the Guerilla Regulatory Strategy article series, shares his take on this new RTA guidance and its implications with Med Device Online’s Jim Pomager.

Michael Drues can be contacted via email or LinkedIn.