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510k Approval

Want to get the FDA 510k approved tag for your product? Maven is all set to guide you for your FDA 510k process.

Are you aware that there are multiple kinds of 510k processes that an organization can go for?

Traditional 

Special 

Abbreviated

These submissions are a bit tedious and consisting of multiple steps and testing requirements. Appropriate planning, support from your end, and guidance from our end would make this process much simpler. 

These 510k are the pre-market notifications! Once cleared, the organization can go ahead with the marketing process. 

FDA bifurcated the new 510k paradigm in two guidance documents – The Special 510k program & The Abbreviated 510k. 

Don’t get confused between these types! They sure have their own merits & demerits. But yes, you will have to demonstrate the equivalence of the device in scope with the already marketed device in the US.

Let’s talk about the first one – The Traditional type!

Once you’ve picked the predicate device for your device in scope, submit the complete documentation requirements as per 21 CFR 807.87. No special form needs to be filled! 

Special 510k? It was mainly established to make an effortless and effective review process of the Device changes! 

Do you need to modify the device which is already available on the US market? Go for the Special 510k! For such type, you will have to emphasize the design controls part (in compliance with 21 CFR 820.30) of the device in scope along with the predicate device of it. Now that the device has already been established and commercially available in the US market, the duration of a special 510k process generally takes the half than the traditional one.

Now, Last but not least – An Abbreviated 510k

Have a relevant renowned standard in mind for your medical device type OR is there a specific guidance document by FDA is available for such device classification? In that case, you can go with the Abbreviated 510k type!

What is 510k submission?

Have a relevant renowned standard in mind for your medical device type OR is there a specific guidance document by FDA is available for such device classification? In that case, you can go with the Abbreviated 510k type!

It is a set of technical documentation that is required by the US Food & Drug Administration (FDA) to sell the medical devices & IVDs in the US market. 

Mainly these documents are to prove the safety and performance of your product. 

Premarket notification / 510k submission for medical devices are reviewed by the FDA’s Center for Devices and Radiological Health (CDRH), mainly, by the Officer of Product Evaluation and Quality (OPEQ). 

When the FDA 510k submission is received by the Document Control Center (DCC), the submission is assigned with a unique control number which is generally referred to as “510k number” or “K number”.

Timelines for the FDA 510k approval?

After the submission, the review mostly takes 60 to 90 days. If any queries are raised or any other documents are required then an AI will be issued or they can issue Refuse To Accept (RTA) if they feel the submission is not up to the mark. The re-submissions against the same are granted with 180 days’ timeline.

How should we do the 510k submission?

All the documents for 510k submission are supposed to be submitted digitally (via an e-copy or the soft copy of the submission in a CD).

Stages of FDA 510k process with Maven –

Registration of an Organization?

For first-time submitters, you must know that to sell the products in the US market, only clearance of the device is not enough, you must register your company as well. To maintain this registration, you will have to pay the Annual Establishment Registration Fee.

One-stop Solution for USFDA 510k

Maven is one of the best regulatory consultants for the USFDA 510k services of your product.

Our vision is to be the most innovative, interactive, consumer-driven & zealously referred Consultancy, being the one-stop solution, leading in the Medical Device Consulting industry, and delight our customers Worldwide.

We provide end-to-end service to get the “510k approved” tag for your product.

Our set of strategies include the complete framework of the detailed planning of the project & execution of it from data collection to the fee payment to USFDA.

A timely solution of the critical aspects of the project, detailed knowledge of the requirements, and collaboration with the testing facilities allow us to make an effective submission to US FDA 510k, which makes MAVEN the one-stop solution for USFDA 510k.

Medical Devices FDA 510k Clearance

As per the 510k section of the FDA, the medical device manufacturers have to register and notify the FDA if they want to sell their product in the USA. This process is called Pre-Market Notification/PMN/510(k).

This process of the FDA 510k Clearance would include the verification of the medical device in scope with the already registered device in the USA. The manufacturer of the device in scope will have to check the classification of the device as well, whether it is matching with the equivalent device which is already having the FDA clearance.

This Premarket Notification will have to be submitted by the Medical Device Manufacturers to distribute their medical devices for the below-mentioned scenarios –

  • Newly introduced medical devices in the USA
  • Reintroduction of modified medical devices in the USA (Changes in design, chemical composition, manufacturing process, energy source, material, intended purpose)

Why choose Maven for FDA 510k?

  • We are industry expert consultants. We are flexible to customize the solutions based on the requirement of the customer.
  • We are a customer-focused, value-based, strong, and resilient team.
  • We create opportunities for success through trusted and reliable companionship.
  • Timely execution of projects as well as adopting practical approach on compliances.
  • Our recognized assets are quality, lead time, dynamicity, flexibility, market needs comprehension, cost-effectiveness, we are eager to say we put the client at the center of our services.

FAQ:

A Premarket Notification (510(k)) is a type of premarket submission that is intended to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed device (21 CFR 807.92(a)(3)) that does not require PMA. To determine if a device is substantially equivalent (SE), FDA considers intended use, design, energy used or delivered, materials, chemical composition, manufacturing process, performance, safety, effectiveness, labelling, biocompatibility, standards, and other characteristics, as applicable.

A 510(k) submitter/holder is the owner of the 510(k). Although, a consultant or correspondent may submit the 510(k) on behalf of the 510(k) owner, that consultant or correspondent is not the 510(k) submitter/holder.

A legally marketed device is a device that was legally marketed before May 28, 1976 (i.e., amendments), reclassified from class III to class II or class I, found substantially equivalent through a 510(k), or granted marketing authorization through the De Novo classification process. The legally marketed device(s) to which the submitter claims equivalence is commonly known as the “predicate.”

A Traditional 510(k) is the most common type of 510(k). In a Traditional 510(k), the submitter provides descriptive information about the indications for use and technology and results of performance testing to demonstrate substantial equivalence.

An Abbreviated 510(k) provides an effective means of facilitating the review of data in a 510(k) through reliance on one or more: FDA guidance document(s); Special controls; or Voluntary consensus standard(s).

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