25 April 2018
Sponsored by: MED Institute
FDA’s guidance on when to submit a 510(k) for a changed device is significant and wide-ranging in its impact. Its revision in 2017 culminated a six-year process that was sometimes tumultuous. This webcast will review key aspects of the guidance, provide historical and other perspectives on its use, and present ideas on how to effectively implement it.
Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Upon the webcast's conclusion, you will be able to:
- Understand FDA’s guiding principles for making decisions about whether a 510(k) should be submitted for a modification to a device.
- Understand FDA’s recommended process for making decisions about whether a 510(k) should be submitted for a modification to a device.
- Understand an industry perspective on the guidance.
Who should attend
- Regulatory affairs specialists and others who make “file/no file” decisions for modifications
- Regulatory affairs managers
- Engineers, marketing professionals and other affected by “file/no file” decisions for modifications
Dan Dillon is a senior regulatory scientist at MED Institute. He has worked for 30 years in the medical device industry, with 28 years of Regulatory Affairs experience. Dillon has worked on over 90 510(k)s, as well as PMA, IDE and HUD/HDE submissions. With this experience has come a broad exposure to a wide variety of medical devices: vascular and non-vascular stents, capital equipment, endoscopes, catheter-based devices, emergency medical devices, drug/device combinations, apheresis devices, software devices and ophthalmological products, to name a few. He has provided regulatory strategy, team leadership and FDA meeting coordination for numerous projects. Dillon is Regulatory Affairs Certified (RAC), a member of Cook Group’s FDA Policy Working Group and provides instruction on FDA submissions at Purdue University. Dan has a M.S. in Applied Statistics from Purdue.