- Is my product regulated?
This is a great question. The quick answer is, it depends. So instead we answer this question with another question, “what does the product do?” And another question, “where do you want to sell the product?”
We will ask clarifying questions, so the answer gives you a clear regulatory pathway. - I have a CE marked device that I’ve sold in the EU for years, how can I get my device on the market in the US?
It is a good start to have a CE marked medical device with some history of use. First determine what classification your medical device is in the US. Are there other products in the US market that are similar in technology and use? Second, create your regulatory strategy. What type of submission is needed? Can the current data in your technical file or design dossier be used to create the FDA submission or does it need to be supplemented with US testing? Are you currently registered with the FDA? The good news is that the strategy for this scenario can be created with options, the benefits and risk associated with each option, and possible mitigations so you can quickly react. A similar approach can be used to create regulatory strategies for all your expansion plans to new geographies.
We can create the strategy, the submission, and processes necessary for your success in the US. - Our new cosmetic skin cream will be better than anything in the US market today. Why can’t I say our cream soothes damaged skin, relieves pain and itching, and stimulates circulation?
For claims the general rules are 1) is it truthful 2) is it supported by scientific data and 3) is it relevant. If you answer yes to all three questions, your next hurdle will the FDA agree that the claims do not provide evidence that your product is intended for use as a drug (directly or implied). In this case, the claims illustrate the product is intended for use in the cure, mitigation, treatment, or prevention of disease. A cosmetic claim for the product might read “…moisturizes the skin and leaves you feeling refreshed”. Also note that your ingredients could cause your product to be considered a drug and not a cosmetic.
Need help with claims and claims substantiation? We can help. - Our organization is currently a distributor in the US, but we want to develop and manufacture our own brand of products. Are our current standard operating procedures adequate?
A great place to start is to do a high-level gap analysis of existing procedures to the qualitysystem requirements. This may include 21 CFR 820 for Medical Devices or 21 CFR 211 for Drugs. If you want to be global, you may also want to be evaluated to ISO13485 and other international standards. With this basic assessment, deliverables and milestones can be created to support your plans for growth. In parallel, you will want to look at developing your products to meet the regulatory requirements for the markets you want to reach. Other steps will include preparing the submission and registrations so that when you are ready to commercial product, the approvals are in place.
We will be by your side all the way. - I don’t have enough resources to close our gaps and keep doing the day to day work, can you help
Absolutely! We know that most organizations work lean, so when issues come up personnel can get overwhelmed. We know that it is not always easy getting approval for new head count or even temporary staffing. What do you do when everything is a priority?
Followell Compliance Consultants is the solution. We can be an efficient and cost-effective way meet competing needs of the organization without adding permanent headcount or exhausting your current staff.
We can:
- Work remotely and visit on-site only when necessary to ensure project objectives are met.
- Create a road-map to mitigate compliance and business risk illustrating that you are
focusing on the most important things first (quality, safety, performance) and that you have targets you are working towards for everything else. - Use a metrics dashboard to help you manage expectations and communicate with your leadership, your shareholders and the regulators that are raising concern over what progress you are making.
