Getting To The Heart of MedTech
Cardiovascular medical devices are an exciting and fast-moving field, home to groundbreaking technologies and bold new therapies.
But when the range of cardiovascular devices covers everything from the stethoscope up to life-saving interventional devices, it can be tough to see the path ahead for your unique product.
In this series of blogs, we’ll demystify the regulatory process for cardiovascular medical devices and break down the FDA departments, federal regulations, product codes, and more that apply to this field.
1) How does FDA define cardiovascular devices?
Cardiovascular medical devices are defined in Part 870 of Title 21 of the Code of Federal Regulations.
They are devices “used to diagnose and treat heart disease and related health problems.”
Though this definition is plainly stated, FDA has an entire office dedicated to cardiovascular devices and their variety of indications, risk profiles, and technological characteristics.
Handling of the regulatory and lifecycle review of all devices in the cardiovascular space, as defined by 21 CFR 870, is done here.
2) Cardiovascular Devices and Intended Uses
The cardiovascular device office is split into three divisions. The division you engage with will depend on the intended uses of your device:
The Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices (DHT2A)
- Blood Pressure and Flow Devices
- Cardiac Ablation, Mapping, and Imaging Devices
- External Heart Rhythm and Rate Devices
- Implantable Electrophysiology Devices
The Division of Circulatory Support, Structural and Vascular Devices (DHT2B)
- Cardiac Occluders and Hemostasis Devices
- Circulatory Support Devices
- Heart Valve Devices
- Vascular and Endovascular Devices
The Division of Coronary and Peripheral Interventional Devices (DHT2C)
- Coronary Interventional Devices
- Peripheral Interventional Devices
- Plaque Modification Devices
3) The Importance of Product Codes
As with all other types of medical devices, every cardiovascular device will have a product code, a risk level, and a submission type associated with it by FDA.
Your device may be anything from a low-risk, 510(k) exempt phonocardiograph, to a moderate-risk, 510(k)-eligible automatic tourniquet, all the way up to a high-risk, PMA-eligible valve repair device.
The regulatory process and data requirements will vary greatly from one product code to another.
This is why one of the most important steps that you can take as you get ready to present your device to FDA is to identify the right product code to base your product development, regulatory, and testing plans on.
The good news is that there are two effective techniques for finding these product codes:
One - You can identify devices on the market that are similar to yours and determine which product code(s) they fall under, and
Two - You can utilize FDA’s product classification database to identify which code(s) fits best
This concludes our overview of cardiovascular devices and how the FDA regulates them.
We’ll dive deeper into the various types and the best strategies for bringing them to FDA in future installments of this series.
If you have a cardiovascular device, we’d love to hear from you. Reach out to a Proxima CRO regulatory consultant, and we’ll help understand the best regulatory path for your product.
Next up is cardiovascular wearables, so stay tuned!