![How to Set Up Clinical Studies to Comply with US FDA Regulations]()
For manufacturers of high-risk medical devices, obtaining data from clinical investigations will be essential to a successful regulatory submission in the US. The Food and Drug Administration (FDA) requires all Class III medical devices to go through Premarket Approval (PMA) prior to being placed on the market in the US.
Clinical data plays a huge role in the PMA application, which means it's extremely important that you are able to set up and run a compliant clinical trial that collects performance and safety data on your device. In order to obtain clinical data that FDA will accept in your pre-market submission, you’ll need to spend time on the front end ensuring that your study complies with all applicable regulatory requirements and standards.
In this article, we’ll cover the basics of setting up your clinical trial to successfully obtain high-quality clinical data for your premarket submission.
BONUS RESOURCE: Click here to download a free checklist that outlines the key steps and considerations for setting up FDA-compliant clinical studies.
1. Get familiar with the FDA’s regulations and guidances
Before you begin setting up your study, you should familiarize yourself with the FDA’s regulations and guidance documents pertaining to clinical investigations of medical devices.
One requirement that you’ll want to cover extensively is the investigational device exemption (IDE). An IDE allows a device that has not previously been cleared by FDA for marketing to be used in a clinical study in order to collect safety and effectiveness data. In other words, if you are undertaking a pre-market study, you’ll need an IDE. Unless your device is exempt from the IDE requirement, you must have an IDE approved before enrolling participants at study sites.
Additionally, you should thoroughly understand Good Clinical Practice (GCP), which refers to the regulations and requirements that a study must comply with in order for FDA to accept clinical data from the study. The FDA’s regulatory requirements for GCP can be found in the Code of Federal Regulations, Title 21:
Another extremely helpful resource is ISO 14155:2020, Clinical investigation of medical devices for human subjects—Good clinical practice. ISO 14155:2020 is the international standard for GCP and an FDA recognized consensus standard, meaning FDA recognizes clinical trials that have been run in accordance with ISO 14155, including clinical data collected outside of the US as long as it maintains compliance with the standard.
2. Create a comprehensive Clinical Investigation Plan
Before you can begin your study, your Clinical Investigation Plan (CIP)—including your study protocol—will need to be approved by an Institutional Review Board (IRB).
Your study protocol should include:
- Study Objectives and Design. Clearly define the study objectives, endpoints, and hypotheses. Choose an appropriate study design (e.g., randomized controlled trial, cohort study) that aligns with your objectives.
Inclusion and Exclusion Criteria. Establish specific inclusion and exclusion criteria to select a suitable study population. This ensures the safety of participants and the relevance of the study results.
Safety Monitoring Plan. Develop a plan for monitoring participant safety, including the identification and reporting of adverse events. This plan should comply with FDA’s guidelines for clinical safety data management.
Labels and Instructions for Use
Your investigator’s brochure will need to include instructions for installation, maintenance, maintaining hygienic standards, and using the device, including storage and handling requirements. You’ll also include any available information that will be placed on the label and its instructions for use. Be sure to check national legislation, as some countries may require labeling and instructions for use (IFU) to be in a national language.
- Study Objectives and Design. Clearly define the study objectives, endpoints, and hypotheses. Choose an appropriate study design (e.g., randomized controlled trial, cohort study) that aligns with your objectives.
- Inclusion and Exclusion Criteria. Establish specific inclusion and exclusion criteria to select a suitable study population. This ensures the safety of participants and the relevance of the study results.
- Safety Monitoring Plan. Develop a plan for monitoring participant safety, including the identification and reporting of adverse events. This plan should comply with FDA’s guidelines for clinical safety data management
ISO 14155:2020 provides an annex that outlines all the information you’ll need to provide in a CIP, which we’ve conveniently summarized for you in our article on the CIP. Aside from your study protocol, your CIP will also need to include a detailed section on statistical design and analysis of the study and your plans for collecting and managing the clinical data from your study.
3. Develop and Implement Data Management Plans
Given all the work that goes into creating a device, creating protocols, selecting sites, getting IRB approval and the myriad other activities that contribute to running a clinical study, data management and collection often take a backseat.
But that attitude reflects poor planning. You must be able to collect and analyze high-quality clinical data in order to get results that FDA will accept in your submission.
If you do use electronic data capture (EDC), you should know that the system you choose will also need to comply with regulations and standards surrounding GCP. That includes the FDA’s 21 CFR Part 11, Electronic records; electronic signatures, and ISO 14155:2020’s requirements for validation of electronic systems.
Whatever EDC solution you choose, it must be able to ensure data accuracy, integrity, and confidentiality. That’s why at Greenlight Guru, we built our EDC software specifically for medical device clinical trials, with built-in GCP templates and an intuitive, secure design that ensures compliance from the start.
4. Obtain IRB Approval for your study
You must have your clinical investigation plan approved by an Institutional Review Board before you can begin the study. An IRB is a group that FDA has formally designated to review and monitor clinical studies.
The goal of an IRB is to protect the rights and welfare of study participants, and they do this in part by reviewing the research protocols and documents like the investigator brochure and informed consent to ensure that the study conforms to GCP. That’s why it’s so important to get a deep understanding of GCP and the FDA’s requirements for clinical investigations.
You can learn more about IRBs and what FDA requires of them in 21 CFR Part 56, but the most relevant point here is that they have the authority to approve (or reject) a clinical study. You must have IRB approval for your study in order for your FDA to accept your IDE application. Keep in mind, if your study involves significant risk, you’ll also need to get the FDA’s approval before beginning.
BONUS RESOURCE: Click here to download a free checklist that outlines the key steps and considerations for setting up FDA-compliant clinical studies.
Get a fast, compliant process for study setup with Greenlight Guru Clinical
Setting up a clinical study to comply with the FDA’s regulatory requirements requires an enormous amount of planning and effort. In a situation like that, what you don’t need are extra headaches and hurdles related to your clinical data collection and management.
Instead, you need an EDC solution that makes it simple to set up your studies, get real-time visibility into data, and improve response rates from your study participants. When you choose Greenlight Guru Clinical, you’re getting all of that, along with dedicated customer service from MedTech professionals who understand the unique nature of medical device clinical trials.
On top of all that, our EDC software comes pre-validated per FDA and ISO 14155:2020 requirements to ensure compliance from the start.
So if you’re looking for a partner who will be with you every step of the way, then get your free demo of Greenlight Guru Clinical today→.
