Florida Medical Manufacturers Consortium Executive BriefingDate: September 21, 2017Time: 8:00 am - 9:30 am
950 Lake Carillon Drive
St Petersburg, FL 33716
The Basics of a 510(k) Medical Device Submission
The 510(k) clearance process is arguably the most important and long-standing medical device approval pathway in our regulatory scheme. Please join us for this special FMMC session covering the key elements of the 510(k) process and submission, including a focus on the most critical pieces of information that trigger questions by reviewers and recent changes to the 510(k) program.
Paul Dryden serves as President of ProMedic, Inc., a medical device regulatory and business development consulting firm. Mr. Dryden has been in the medical device industry since 1975 and has lead hundreds of successful 510(k) submissions. Prior to forming Promedic, Inc. in 1992, Mr. Dryden was President of Dryden Corporation, Indianapolis, IN, an anesthesia / respiratory disposable manufacturer.