FDA 510(K) Submission & Certification for Germany.
US FDA Medical Devices Regulations
US FDA is a regulatory body for medical devices marketed in the USA. To register medical devices in the USA, one must have 510(k) clearance from US FDA. Achieving 510(k) Clearance is a challenging aspect of medical device development. Operon Strategist’s medical device regulatory consulting team will assist you in the 510(k) clearance process. FDA 510(k) is the name of the process that determines that the device is safe and effective and hence manufacturers can legally sell that device in the US market. Most of the class 1 medical devices are exempted from 510(k) requirements.
What is FDA 510(k)?
- It’s a process of determining that device is safe and effective and can be legally place onto the US market.
- FDA 510(k) is a technical file that contains information on the device.
- Most of class 1 devices are exempted from the 510(k) requirement.
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How to Register Medical Device in US FDA?
All companies who want to sell their product in the US market need to register with USFDA first. Most of the class 1 devices are self-registered but class 2 devices need FDA 510(k) submission whereas class 3 devices Pre-market submission (PMA) is needed. The medical device regulatory consultant can guide you for 510(k) submission or PMA process or you can visit to USFDA website.
Medical Device Classification For US FDA Registration:
FDA 510(k) medical device classification depend on the intended use of the device. The devices are classified as Class 1, Class 2, and Class 3 medical devices as per the risk associated with them.
Class | Type of Risk | Examples |
Class 1 | Low risk (General control) | Hospital furniture, Bandages |
Class 2 | Moderate risk | Catheters, surgical gloves |
Class 3 | High risk | Pacemakers, defibrillators |
The medical device classification can be confusing for manufacturers as they have limited exposure to the system. Class 1 devices are subjected to fewer regulatory requirements as compared to class 2 and class 3 devices. For the regulatory compliance of your medical device, you should know the class of your device, so that you can apply for FDA 510(k) clearance or PMA process.
How Can Operon Strategist's Help in US FDA 510(k) Registration?
We have an experienced team of professionals, who are closely working with notified bodies and fully aware of regulatory updates required for compliance of the device. If your device requires FDA 510(k) approval our team will help you in identifying the predicate devices, evaluate the substantial equivalences, and assist you in creating a 510(k) technical documents file. In addition to this, we guide our clients to respond for additional information needed to FDA or to the queries that arise if any. Our QMS specialized team helps manufacturers to comply with 21 CFR part 820 QSR requirements.
To discuss your support needs you can mail us at enquiry@operonstartegist.com or you can WhatsApp us your queries we answer them shortly.
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