Getting your Class II Medical Device in US Market requires several steps of 510k clearance. Before you begin the submission it’s necessary to understand,  what is exactly 510k?

Medical Device Manufacturers and Developers must be ready with required documents to ensure the fast-paced Go-To-Market of the Medical Device.

Content Outline

What is 510k and its clearance process?

510k approval is a process to get marketing clearance for a Class II Medical Device. Class II Medical Devices are non-invasive devices usually meant for secondary treatment and aid. 510k is also referred to as Pre-Market Notification.

The process of getting a 510k clearance requires finding an equivalent product (predicate device) to a new product to prove its substantial equivalence. Once the device is proven equivalent to an already approved equivalent it can be legally marketed as per US FDA guidelines.

How is 510k different from PMA?

PMA refers to Pre-Market Approval.
Pre-Market Approval is the process of approval for a new product.
PMA process is much more complex process involving proper clinical studies, evaluation and report analysis.
510k is about finding a substantial equivalent (predecessor with same technology) of the new product.
The process isn’t very complicated as PMA.
The documentation process of the 510k process involves presenting all the facts stating that predicate’s clinical studies and results are pretty much similar to new device. There are no significant changes made in terms of technology and intended impact of the product.

510k submission checklist

The entire process of the 510k is divided into two phases:

(I) Acceptance Review

Acceptance review takes up to 15 days. In case, the 510k is not accepted at the primary level, RTA is issued. RTA refers to Refuse to Accept. In such a case some more documentation is needed to validate the product.

(III)Substantive Review

The substantive review takes up to 60 days. At this stage, the approval body may ask for additional information to justify the indicated use of the product.

What does FDA require as additional information?

The additional information, in general, has those facts that completely justify the intended use or impact of the product.
Additional information requests include:
a. Improper device description
b. Discrepancies in the indications for use or device description
c. Data related to indicated use
d. Inability to comply with set standards or regulations
e. Non-satisfactory clinical data

Characteristics of a Predicate Device

1. The device must have the same intended use as the predicate device
2. The technology of the device must be similar to the predicate device
3. The device must offer the same level of safety and effectiveness as the predicate device

How does Special 510k differ from Traditional 510k?

Parameter 510k Special 510k Traditional
Time 30 Days 90 Days
Relevance For products having nothing much different from Predicate For products having slightly major difference than Predicate
Technology Same Technology as Predicate Device Same technology but slightly modified
Indication Same indication as the Predicate A slightly modified intended impact and use
Clinical data Not Required Required for evaluating safety of device post modifications in existing technology

A major difference between a Special 510k and a Traditional 510k is the period required for submission & approval. A special 510k process requires up to 30 days for processing whereas a traditional 510k requires at least 90 days for approval.
A special 510k is applicable in cases when nothing much is to be done to proceed with the approval process:
1. The change done to the device is very minor and legally the manufacturer can easily pitch the product to market.
2. A special clinical study is not required for performance data.
3. Performance data can be reviewed or analyzed in a summary format.

Nature of the device

Several devices have technology differences in certain areas including Artificial Intelligence and Cybersecurity. FDA is still mapping out guidance on going ahead with the approval of devices based on new technologies. One should fix a meeting beforehand to avoid unnecessary delays if they have any such technology in their device.
FDA has become highly sensitive to growing concerns of cybersecurity risks in new-age Medical Devices. This makes it extremely important for developers to document each step of the software development in medical devices to ensure safety and security. A minor glitch at the documentation phase can make things messy during the approval phase.

Administrative aspects of 510k submission

Submission of application at the right address

  • The address to apply might change with time. It is important to look at the FDA website before sending.
  • Combining the hard copy as well as eCopy as per the latest FDA submission guideline
  • Be ready with printed and E- copies of the application. At least one eCopy and one printed copy are necessary for submitting.


510k approval 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 510k clearance.
Signing up with an experienced Contract Manufacturer can help you achieve 510k easily. A seasoned manufacturer is well versed with the documentation and submission process and this eventually will enhance your Time-to-Market.
Johari Digital Healthcare Ltd. has an experienced team hands-on with regulatory and approval processes. Along with seamless manufacturing services, we can help you fast pace your product to Go-To-Market.




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