In this week’s blog, we will provide some basic clarification regarding product intended use, label and off-label promotion and their limitations. These issues are covered in many separate guideline documents and regulations issued by the FDA and other agencies (e.g. …
This blog will help you to understand how medicinal substance levels may affect borderline product classification and, more specifically,medical devices incorporating a medicinal substance with an ancillary action. The status of many products on the “borderline” between medicinal products and …
Writing a successful 510(K) FDA submission is a difficult and demanding task, but using my 10-word PREDICATE formula will make this challenge a lot easier for you. The following are the major steps you should consider in every FDA 510k …