We think it could. Final guidance for FDA “Breakthrough Devices Program” was published in December 2018. As this could be potentially relevant for many medical devices in development, we thought it would be worthwhile bringing it to your attention. Ultimately, …
The purpose of this blog is to provide initial info about certain regulatory pathway options, or the lack of these, for products containing cannabis or for cannabis derived compounds in the United States and European Union. The reader should bear …
Clinical evaluation represents a methodologically sound ongoing procedure to collect, evaluate and examine the clinical data relevant to a medical device. As the application date for the new Medical Device Regulation MDR approaches, many clients have turned to us to …
Veterinary medical devices regulation is a seldomly discussed topic and therefore BioReg Services have decided to share with you our knowledge and experience within the EU regulatory framework and veterinary medical device market. Let’s start with a comparison of the …
In this post, we will try to summarize all you have to know in order to design Post Marketing Surveillance – PMS and Post Marketing Clinical Follow Up – PMCF plan for your medical device in compliance with the new …
Mobile Medical Applications (Apps), including General Wellness Products, can help people manage their own health and wellness, promote healthy living and gain access to useful information when and where they need it. These products are integral parts of our lives, …
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 …