As a startup founder, you’re already taking on massive risk by investing your time and resources into an idea that could change the world. You have no shortage of exciting concepts that you might want to pursue, but without FDA buy-in and increased funding, it can be difficult to make headway toward your goal. This guide will help you navigate the process of finding out what it takes to win FDA approval for your product — from determining if in fact a product needs FDA approval in the first place to working with an agency full stop.
This post will also touch on some of the things you should know before approaching any potential investor or partner so that they are given accurate information about what they are aiding in.
There are three primary places to start your research on FDA compliance: FDA.gov, The Federal Register, and the FDA office nearest you. One of these is the easiest place to find a list of actual products that have been approved by the FDA; however, those products are outdated by about a decade — so if you’re looking for the latest and greatest in the world of medical technology, you’ll need to comb through at least two or three websites from each section listed below (or use one or all of them!).
The easiest way to start is with FDA.gov, so let’s begin there. There are three primary sections you’ll want to comb through: Medical Devices, Federal Register Notices and Freedom of Information Act (FOIA) Requests. The medical device list is the most comprehensive source of pre-approved medical devices on the internet; however it is also several years out of date.
In the FOIAs section , you can read the findings of FDA investigations into various companies both large and small. If you’re trying to determine if your product would fall under regulation by the FDA, this is where you would start your search for current documents that might help shed light on your product’s status with the FDA and/or its potential competitors.
The Federal Register is a good place to get information about the regulation of your specific product. The notices section is especially useful because it allows you to search products by medical technology category, as well as type of procedure (i.e. minimally invasive surgery). When searching the Federal Register you can also set your search parameters by issuing authority, which takes you straight to the source — i.e. the FDA — without having to go through several pages of hits that might not be helpful in your search.
If, on the other hand, you’d like to dive into the nuances of how the FDA views specific medical technologies and how they might affect your product’s regulatory pathway, you’ll want to visit the FDA website in your area. Start by clicking here , and then select your state from the dropdown menu. From there, you’ll be able to search for a specific address where you can start asking questions about compliance. If this is too time consuming or disorganized for you as a first step, feel free to email me at [email protected] and I can help guide your information gathering process by looking up data on specific products and companies.
Once you have an exact product in mind, it’s time to get serious about getting under the hood and figuring out what your FDA regulatory pathway will be. If your product falls into one of the following categories, you’ll need to file for 510(k) pre-market approval. This process can take several years and requires copious amounts of research into similar products on the market along with the available literature for each of them. If your product does not fall into one of these categories, you are considered a Class I Medical Device and are exempt from pre-market approvals (see section 4).
The five classes of medical devices (as defined by 21 CFR 801.4) are Class I, II, III, IV, and V.
Class I devices include:
Includes class I devices that are in production for more than 5 years and have had no design changes. Examples include bandages and tongue depressors. The general standard for these devices is that they must be “substantially equivalent” to a class I device already on the market. In addition, class I devices must still meet all applicable standards set by the FDA before they can be sold to consumers in the United States; i.e., the FDA requires clinical testing to ensure the safety of all Class II through Class IV interventional procedures used on humans prior to approval of a new drug or medical device).
Class II devices include:
Includes class II devices that are in production for at least 1 year and have had no design changes since the time they were initially classified as a class II device. Examples of class II devices include prescription eyeglasses and contact lenses. Class II devices do not have to be substantially equivalent to any class I or class III device already approved by the FDA, but they do have to comply with general safety and effectiveness standards (as set forth in 21 CFR 806). The FDA can also require either clinical data or non-clinical data as a basis for approval. Clinical data is obtained from studies involving human subjects. Non-clinical data is obtained from in vitro studies, animal studies, and any other studies not involving human subjects.
Class III devices include:
Devices that present a potential unreasonable risk of illness or injury (as defined by 21 CFR 890.3(f)) that is not corrected by the FDA through premarket notification to the manufacturer or by other means. Examples of Class III devices include lasers and surgical power tools. (Class III devices may fall into other classes as well, depending on the specific risk of risk assessment performed by the FDA).
Class IV devices include:
Devices that present only a remote or theoretical possibility of causing harm to the patient. Examples include lasers. (Class IV devices may fall into other classes as well, depending on the specific risk of risk assessment performed by the FDA).
Once you’ve determined your product falls into one of these classes, it’s time to contact a medical device law firm in your area and get them to file for 510(k) pre-market approval on your behalf.
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