The US Food and Drug Administration (FDA) medical device approval process can seem arcane and arbitrary to many companies. Where a potentially healing, life-saving technology exists, it is hard to understand why there is not a clear and instant path through towards approval for the medical device in question. Yet it is important to understand the FDA process in order to find the best means through agency:
In order to market most kinds of medical devices in the US, the FDA requires companies to obtain “premarket approval” of their devices. That means that they must apply to the FDA to approve the medical device in advance of placing it on the American market. However, there are two means to do so: the Premarket Approval approval process is for new types of medical devices for which no predicate device currently exist. That is a process that usually takes longer, because the FDA has to determine from scratch the proper standard for approval. By contrast, the Premarket Notification process via the 510(k) submission take a device that has already been approved by the FDA and tells the agency “we are essentially the same as the predicate device.” In that case, the FDA already has determined what standards it will use for approval.
In order to not waste companies’ valuable time and resources, the best practice is to request a pre-submission meeting from the FDA. This means coming up with a full device description and specifications as well as desired product claims for the medical device, as well as the proposed safety and efficacy testing on the device. A meeting – either by phone or in person – can then be scheduled with the Agency, which will then essentially tells the company “you also need this testing” or “change this testing,” and sometimes even helps with specifying the appropriate testing protocols for a given device.
Even when the regulatory pathway for a given device is clear, it is important for companies to realize that they will need FDA good manufacturing practices – a kind of quality system – in place in order to actually legally produce and market the device. This is the case whether they are based in the US or abroad.
For certain very low-level devices, the FDA will allow a company to register their device, requiring no pre-market approval. However, in that case, the company is prohibited from indicating or even implying that its device has been “approved by the FDA” because that would be misleading. It is also prohibited from making claims beyond the limited claims allowed by the registration.
* Information contained on this page is not meant to constitute or substitute for specific legal advice addressing actual legal situations as is meant as general guidelines only. Readers are advised to seek competent legal counsel appropriate and tailored to their particular legal situation.
Why Is OTC Drug Compliance Necessary The US Food and Drug Administration (FDA) reviews and subjects all over-the-counter (OTC) drugs to the highest level of safety and effectiveness before allowing companies to release the drug to the public…