In the U.S, the FDA regulates the sale of medical device products. To gain the FDA’s approval to sell a medical device, businesses must first present evidence of the products safety and effectiveness for its intended use. These regulatory approvals are just a piece of the product launch process but can be hard to manage. There are many steps and moving parts to this process, so we created a comprehensive guide to navigating FDA regulatory approval process. At Nortech, we understand how overwhelming it can be for startups and new product launchers to get started. Although Nortech does not provide consultation on regulatory approvals, we strongly recommend our clients partner with a consultant who is experienced in managing the regulatory approval process.
The Steps to Take
In general, there are six steps to ensure a successful pre-clinical inspection. Explore our guide to navigating FDA regulatory approval process below.
Step 1: Classify Your Device
The classification of the device will determine the regulatory control during and after the marketing process. In the U.S, FDA regulations have established three regulatory classes to list your medical device.
1. Class I devices present minimal potential for harm to users and are often simpler in design. Devices and Items considered Class I include items like enema kits, elastic bandages, surgical gauze and more.
2. Devices categorized as Class II are of moderate risk. They are described as insufficient to provide reasonable assurances of the safety and effectiveness of the device. Things like catheters, syringes, and blood transfusion devices are categorized as Class II devices.
a. Class I and II devices are subject to less rigorous regulatory processes, and their approvals are focused on registration, manufacturing, and labeling and do not require pre-clinical or clinical data.
3. The last class of devices include implantable peacemakers and other devices. These are considered Class III devices. Medical devices like these are life sustaining and substantial in preventing deterioration of human health.
Learn more about regulatory assistance from the FDA.
Step 2: Select the Pathway
In the US, there are generally four pathways to take when considering device approval:
1. Pre-Market Approval
2. Pre-Marketing Notification
3. Humanitarian Device Exemption (HDE)
4. Emergency Use Authorization
Premarket Approval is a scientific regulatory documentation to FDA to demonstrate the safety and effectiveness of a Class III device. The approval is not usually needed for a Class I or II device. In a PMA, the device must have sufficient scientific evidence establishing its safety and efficiency. If FDA regulations determine the device has an acceptable predicate (a device which is similar and legally marketed), a PMA application is not needed and PMN can proceed. However, pre-marketing notification (also known as the 510(K) application) is a premarket submission. It’s made to the FDA to demonstrate a device is as safe and effective to one or more similar legally marketed devices.
Humanitarian Device Exemption: The HDE requires demonstration of a devices-relative safety, but not device efficacy. HDE is exempt from the effectiveness requirements of sections 514 and 515 of the FD&C Act and is subject to certain profit and use restrictions. Humanitarian Use Devices are devices intended to benefit patients by treating or diagnosing a disease or condition manifested in fewer than 8,000 individuals.
Emergency Use Authorization: Pressing matters may arise to use an investigational device in a manner inconsistent with the approved investigational plan or by a physician who is not part of the clinical study. Emergency use of an unapproved device may occur before an IDE is approved. The sponsor must notify the FDA of the emergency use within 5 days through a submission of an IDE Report. The report must describe the details of the case and the patient protection measure as followed.
Criteria:
- Life threatening or serious disease or condition.
- No alternative.
- No time to obtain FDA approval.
Step 3: Clinical Trials
If the device requires a full PMA (Class II or III devices), clinical trials will be required, and the investigator should prepare an IDE application. The PMA can proceed after obtaining sufficient clinical evidence. Not all medical devices will require clinical trials before they are approved for market release in the US. Additionally, clinical research is broken into a series of “phases” beginning with pilot studies, then safety testing, then efficacy testing, then clinical efficacy.
Step 4: Prepare the Application
The applicant must supply information about the device indications and function. This includes basic scientific concepts, a summary of adverse safety and efficacy information, procedures to control risks, alternative procedures and treatments to the device, summary of pre-clinical and (in the case of PMA, HDE, and some 501[k]) clinical trial data, and a bibliography of references. As part of this, you will need FDA verification and validation of your device.
FDA Verification
FDA verification is important for making sure the requirements you set are fulfilled.
You should be prepared to answer these questions:
A. Are You Designing the Device Correctly?
• Requirements are implemented
• Requirements are verified
• Requirement standards are met
B. Are You Designing the Right Device?
• Device is effective for intended users
• Stakeholders within your company
• Regulatory stakeholders
Step 5: Submitting to the FDA
The FDA will assign a lead reviewer and notify the applicant of acceptance for a complete review.
Step 6: Register & List Device
Once the FDA has approved the device application, the sponsor must register the business that will produce and distribute the device within the United States and “list” their device.
Tips to Manage the FDA Regulations Process
Seek Guidance & Consult Experts
Submitting documents to the FDA for approval can be a complex and time-consuming process. Even experienced sponsors sometimes omit necessary steps or overlook action items. To ensure successful completion of this critical task, seek early advice from professionals who have been through it before. Consultants, industry veterans and experts will know exactly what’s required every step of the journey toward product approval. Start connecting with these experts upfront to save valuable resources while also setting yourself up on the path towards success.
Find Quality Manufacturers
Work with a manufacturer dedicated to quality management and manufacturing. At Nortech, we have a flexible and robust quality system. Our in-depth system helps us spot obsolete components in products, as well as other software and tools with a variety of capabilities to complete link and trace and different analysis. We have a variety of testing equipment, as well as design capabilities we use to further prepare our client devices for regulatory approval processes.
It can be challenging to put all the pieces together to gain approval for new devices. Our team at Nortech is ready to provide design, engineering, and manufacturing support to you on this journey. With our guide to navigating FDA regulatory approval process and a trusted manufacturer, your devices will be approved more efficiently than ever. Contact a trusted Nortech representative for more information today!