Regulation of Homeopathic Products in FDA Many people ask me about the regulation of homeopathic drugs in the US and about the legal side of homeopathy in FDA in general. So, we’ve decided to provide more info on how the …
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 …