If you’re a pharmaceutical, biotech or medtech business entering the US market, the Food and Drug Administration (FDA) approvals process for new drugs and devices can be daunting. But understanding this increasingly complex regulatory landscape is crucial for successfully bringing products to market.
This article summarises the different types of approvals for drugs and medical devices, the steps involved and the challenges businesses may face along the way. The approvals process is long and involved but there are tried-and-tested strategies for success. These include working with a pharmaceutical or medical device consultancy that can offer unique insights and draw on industry experience to boost your business’s chances of success across the entire development lifecycle.
The different types of approvals for drugs and medical devices
The FDA oversees various types of approvals which cover different products. Understanding which approval pathway applies to your new drug or medical device is the first step to navigating the regulatory landscape.
For drugs:
1. Investigational New Drug (IND)
An IND allows manufacturers or marketers (sponsors) to transport drugs across state lines as they begin pre-clinical development to establish if the product is reasonably safe for use in humans and is promising enough to justify development. It also changes the legal status of the molecule, so it’s subject to the requirements of the regulatory system.
2. New Drug Application (NDA)
NDAs allow sponsors to ask the FDA to approve a new pharmaceutical for sale and marketing in the US. They are required for new molecular entities or new formulations of existing drugs.
An NDA must provide the FDA with enough information to decide whether a drug is safe and effective, its benefits outweigh the risks, the proposed labelling is adequate and the manufacturing methods meet specific standards.
3. Abbreviated New Drug Application (ANDA)
ANDAs cover generic versions of approved drugs. These applications must show that a product works like an approved drug, so new pre-clinical and clinical data isn’t required to establish safety and effectiveness.
For medical devices:
Medical devices are categorised into three classes (I, II or III) depending on the degree of risk they present. These categories determine the type of application required.
1. 510(k) (Premarket notification)
A 510(k) is needed for most moderate-risk (class II) and some low-risk (class I) devices. A 510(k) requires a sponsor to show that their new device is “substantially equivalent” to a device already on the market.
2. De Novo Classification Request
These cover medical devices where there is no substantially equivalent device on the market. This pathway applies to novel medical devices that pose a low or moderate risk.
3. Premarket Approval (PMA)
For high-risk devices (class III) or novel devices that are not eligible for 510(k) or De Novo pathways. A PMA must include sufficient evidence that a device is safe and effective for its intended use.
The approval type significantly impacts the overall development process and time to market, as each pathway has unique requirements, timelines and associated costs.
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Let’s TalkStep-by-step: the process of approving drugs and medical devices
While the exact process can vary depending on the product and approval pathway, the process of approving drugs and medical devices typically includes:
Pre-clinical research and prototyping
- Drug researchers conduct pre-clinical in-vitro and in-vivo studies to demonstrate basic safety and provide detailed information covering toxicity and doses. After review, they decide whether a drug should move to human trials.
- Medical device researchers build a prototype and test this in laboratory conditions to understand its potential and possible risks.
- All teams must remain compliant with Good Laboratory Practices (GLP) set out by the FDA.
Clinical trials
- Drug sponsors submit an Investigational New Drug (IND) application for drugs. Once the FDA has completed a review, sponsors can conduct phases I, II, and III of clinical trials.
- For certain devices an Investigational Device Exemption (IDE) is required. Once this is approved (if applicable) clinical studies can begin.
- All teams must comply with Good Clinical Practice (GCP) guidelines set out by the FDA.
FDA submission
- Sponsors prepare and submit the appropriate application (an NDA or ANDA for drug submissions and a 510(k), De Novo, or PMA for medical devices), including all required information, product details and clinical data.
FDA approval
- The FDA reviews the submission over a 6-10 month period. They then decide whether to approve or reject the application or request more information.
Post-market monitoring
- Once products are available for use by the public, the FDA continues to monitor the safety and performance of all drugs and devices in real-world conditions. Sponsors must report any adverse events and conduct any post-market studies that are required.
The challenges of meeting FDA requirements
FDA regulations are complex and extensive. For businesses new to the process, they can be difficult to interpret and navigate. The approvals process can take years and requires significant time and resources, which can pose a real challenge to smaller companies or those with limited budgets.
Throughout the full regulatory lifecycle, sponsors must generate, organise and present large amounts of data, which can feel overwhelming. In order to do this, clinical trials need to be designed and executed in a way that generates all the necessary data and complies with all essential regulations. All the while, effective communication with FDA contacts remains crucial.
What’s more, FDA regulations frequently change, which means teams need to stay up to date in order to stay compliant. There are also significant post-market requirements to consider and meeting these ongoing obligations can put further strain on resources.
FDA approval: strategies for success
Starting early and staying ahead of the approvals process is key when it comes to navigating the regulatory landscape. This means incorporating regulatory considerations into your development process from the start and engaging with the FDA and answering any questions they might have promptly.
It also pays to develop a comprehensive strategy before you take action. This will help you plan your entire pathway (from pre-clinical studies through to post-market monitoring), get a strong team of professionals in place to avoid delays and build compliance requirements into your ways of working before you begin.
Even with these strategies in place, the approvals process can take time, requiring patience and persistence. That’s why many businesses entering the US market work with a pharmaceutical or medical device consultancy to maximise their chances of gaining FDA approval. These industry experts have experience working with FDA teams and can draw on tried-and-tested strategies to shorten timelines, save money and ease the process.
How MWB Consulting can help
We’re specialists in pharmaceutical and medical device consulting with over 20 years of experience of global regulatory processes, including FDA approvals. Our extensive understanding of the full lifecycle of drug and device approvals means we can guide you through individual steps or the full end-to-end approvals process to clarify requirements, optimise your strategy and maximise the likelihood of a successful product launch.
Partnering with our in-house team of subject-matter experts will help you save time and money while you meet legal requirements, hit business goals and bring innovations to the market efficiently and safely.
Need help with drug or device approvals?
Contact us today for an initial, free-of-charge discussion with a senior consultant about your project.
Let’s Talk