FDA 510K Submission & Certification for Saudi Arabia
What is FDA 510(k) for Medical Devices Manufacturers in Saudi Arabia?
FDA 510(k) is necessary if you want to trade your medical devices in the US market. FDA 510(k) for medical devices is submission of technical file for the clearance of the 510(k). FDA 510 (k) submission provides evidence that the devices are substantially equivalent to predicate devices. Usually the 510(k) submission takes 30-90- days.
Saudi Arabia 510(K) Medical Device Classifications:
Determining whether you need FDA 510k or PMA for your medical device will depend on the classification of your device. Every device manufacturer who wishes to trade in the US market needs to classify their medical device as Class I, II, and III. Premarket approval application (PMA) is not necessary if those are meant to human use, but must submit FDA 510 (k) unless the device is exempt from 510 (k) necessity of the Federal Food, Drugs and Cosmetic Act (the FD&C Act), and does not overreach the circumstance of exemptions of the device classification regulation chapters (e.g., 21 CFR 862.9, 21 CFR 864.9). FDA classifies medical devices in three categories as Class I, II, or III as per the risk. Class I medical devices are low risk, whereas Class III devices are high risk. Generally, FDA “clears” moderate-risk medical devices (Class II) (for example dialysis equipment and many types of catheters) for marketing once it has been demonstrated that the device is substantially equivalent to a legally marketed predicate device that does not require premarket approval.
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What Are the Types of FDA 510(K)?
There are typical 3 types of 510k established under the US FDA clearance system. The Traditional Program is the original submission type as provided in 21 CFR 807. In 1998, the FDA developed both the Special and Abbreviated 510k Programs to facilitate the review of certain types of submissions subject to 510k requirements. These Programs were previously described in The New 510k Paradigm guidance. In 2019, the FDA split “The New 510k Paradigm guidance into two distinct guidance documents: The Special 510k Program and The Abbreviated 510k Program. The Special 510k and Abbreviated 510k submission types can be used when a 510k submission meets certain factors.
Traditional FDA 510k:
This type of 510k is what is known as the original 510k submission or for a change/modification done to a previously cleared device under 510k. This may be used under any circumstances.
Abbreviated FDA 510k:
This type of 510(k) is when the submission relies on:
- FDA guidance document(s),
- Demonstration of compliance with special control(s) for the device type, or
- Voluntary consensus standard(s).
Special FDA 510k:
This type of 510(k) is considered when there is modification to a device however modification should have no effect on intended use or alter the fundamental scientific technology. Examples for these modifications can include:
- Change in environmental specifications
- Change in performance specifications
- Change in ergonomics of the patient user interface
- Dimensional specifications
- Software or firmware
FDA 510k Clearance Specifications in Saudi Arabia:
The FDA 510(k) or PMA will depend upon the classification of medical devices. If medical device falls under Class I, II, premarket Approval application (PMA) is not necessary but they must submit FDA 510(k) unless it is exempted from 510(k) necessity of FD&C Act. As a FDA 510k Clearance process consultant we identify the predicate device and assist our clients in creation of technical dossier for 510(k). We help our national and international clients to achieve their FDA compliance. The terms 510(k) and PMA may sound similar but they are different.
Points of consideration;
- A 510(k) is an application which need to be submitted to FDA in order to sell a product in US market. An FDA 510(k) is submitted for the class I, Class II and certain Class III, devices, where substantially equivalent product found in the market.
- PMA means Premarket Approval Application is required for certain Class III; devices where substantially equivalent product is not existed in market.
Who Needs FDA 510 k and Why?
The domestic medical device manufacturers from any country trying to introduce a new device to the US market. Re-packers or Re-labellers who make labelling changes or whose operations significantly affect the device. In simple words, FDA 510 k is the name of a process, but technically it is a complicated and equally important process to submit your device documentation for clearance, To determine whether the device is safe and effective and hence permissible to legally sell in USA market. FDA 510k Guidance gives an idea whether the product is safe and as per the safety rules of FDA or not.
How Operon Strategist Assist you?
Many times, manufacturers in Saudi Arabia underestimate the FDA 510 (k) submission process which lead them in delaying their clearance process. Our experience and understanding helps you to minimize the time for the submission process. Our team creates a clear road map through which you can minimize the quality system implementation errors. We are handling national as well international project for more than 12 years. Our global presence helps us to get associate with various regulatory bodies and give us a chance to provide qualitative service.
Why Kingdom of Saudi Arabia (KSA) Manufacturers Must Choose Us for FDA 510(k) Submission?
Manufacturer faces problems in FDA 510k clearance due to
- Poorly written cover letter,
- Incorrect classification
- Lack of knowledge in clinical trial.
Our experienced team can handle all type of queries related to FDA 510(k) clearance submission & take hard efforts to work on the clients need and provide satisfactory results. We provide assistance to clients in:
- Submission of documents of 510(k), DMF or PMA to FDA as per requirement
- Classification of medical devices.
- Comparison of device with the predicate devices.
FDA 510(k) signifies that the device which is to be marketed is safe and effective. The appliers may market their device after the 510(k)clearance.
If you are looking for FDA 510(k) consultant in Saudi Arabia you can easily contact to Operon Strategist medical device regulatory consultancy for fast and error free deliverables.
FAQ
Which agency regulates medical devices in Saudi Arabia?
In Saudi Arabia, the Saudi Food and Drug Authority (SFDA) is the regulatory agency responsible for overseeing and regulating medical devices. The SFDA is tasked with ensuring the safety, efficacy, quality, and proper use of medical devices within the country. They establish regulations, set standards, and evaluate medical devices to ensure compliance with the established requirements before allowing them to be marketed and used in Saudi Arabia. Manufacturers and distributors of medical devices must comply with the SFDA's regulations and obtain the necessary approvals or licenses before commercializing their products in the Saudi market.
Is 510k FDA approved?
A 510(k) submission is a premarket application sent to the FDA to prove that the device intended for market release is equally safe and effective, essentially comparable (SE), to an already legally marketed device that does not require premarket approval (PMA).
What's the best way to expedite FDA approval for a medical device?
The best way to expedite FDA approval for a medical device is to First research your requirements. As with any project, gathering specifications – in this case regulatory registration requirements – is paramount. Most firms have heard of the 510(k) Premarket Notification pathway, but there are others. If you cannot identify a 510(k) Predicate device that demonstrates Substantial Equivalence, then formally reach out to the FDA. There are outreach tools to help identify which pathway is right for you.