510k Process Guide
Manufacturers around the world are aiming to launch their medical innovation in the United States! This is because of the apparent ease of doing business in the US and the size of the market. But, before you plan out your steps, let’s understand different terms associated with the same.
In the previous blog, we have tried explaining who can sell in the USA. For this blog, you will gain some insights into the US FDA’s 510(k) process.
What is the 510(k) Submission Process?
All medical devices and innovations are classified differently under different regulations around the world. A 510(k) clearance is a process that helps class II medical manufacturers get a marketing clearance for their devices. Usually, a class II medical device is a non-invasive device used for secondary treatment. In layman’s terms, 510(k) clearance is also known as Pre-Market Notification. For this process, the manufacturer needs to find a predicate device or an equivalent product compared to the new product to find ‘Substantial Equivalence’. ‘Substantial Equivalence’ means that the new device is as safe and effective as the Predicate.
A claim of ‘substantial equivalence’ does not mean the new and Predicate devices must be identical (Read more about ‘substantial equivalence’ by clicking here). Once the device is proven equivalent to an already approved device, it can be legally marketed as per US FDA guidelines.
Manufacturers often get confused between 510(k) and PMA. To eliminate this confusion, our experts have created this easy-to-understand Infosight.
Once you understand this difference, the process gets easier, or “Complex.”
510(k) submission is a phased process and is divided into 2 phases.
Phase 1 – Acceptance Review
This process takes up to 15 days. Often manufacturers miss this review and receive an RTA – Refuse to Accept. Incomplete documentation serves as a common reason for such primary rejections.
Phase 2 – Substantive Review
This review takes up to 60 days. It is at this stage where the regulator may ask for documents justifying the indicated use/ intended purpose of the product.
Common documentation errors.
Manufacturers often miss certain elements from the files, which could lead to RTA. Let’s understand what additional files FDA can ask for:
- - Document justifying the intended use/ intended purpose of the product
- - Device description
- - Discrepancies in intended purpose/ device description of the product
- - Data related to intended use/ intended purpose
- - Justification on quality management or regulatory requirements
- - Clinical data
Difference between Traditional 510(k) and Special 510(k)
One of the major differences between a Special 510(k) process and a Traditional 510(k) process is the period required for approvals and submissions. A Special 510(k) process requires up to 30 days, whereas a Traditional 510(k) process requires at least 90 days for approvals.
A Special 510(k) process would be for products which:
- - have little difference to the Predicate Device
- - have the same technology as the Predicate Device
- - have the same indication as to the Predicate
- - don’t require Clinical Data
A Traditional 510(k) process would be for products which:
- - have more differences to the Predicate (but are still similar)
- - have the same technology but slightly modified
- - have a slightly modified intended impact and use
- - require Clinical Data for evaluating the safety of devices post modifications in existing technology
510(k) clearance is easier if you ensure whatever is done is recorded from day one. Failing on the recording part makes it inconvenient and difficult to obtain 510(k) clearance.
By appointing Experts at Med-Di-Dia as your Contracted Partner for your US requirements, we will be your regulatory risk partner for Medical Devices, Diagnostics and Digital Health!
Contact us by sending an email at mdd@mddltd.com
Or, call us on +353 (0)91-704804
