FDA 510(k) Clearance Process

Freyr provides solutions for navigating the FDA 510(k) clearance process for medical devices, offering comprehensive support tailored to your needs. Our seasoned 510k FDA consultants guide you through traditional, special, and abbreviated 510(k) applications, thereby ensuring compliance with FDA regulations.

FDA 510(k) Clearance Process

At Freyr, we specialize in providing comprehensive 510(k) services to assist you in navigating the FDA 510(k) clearance process for your medical devices. Our team of Regulatory experts is well-versed in the intricacies of FDA regulations, ensuring a smooth and successful journey toward obtaining the FDA 510(k) clearance. Explore our wide range of services tailored to assist you with your 510(k) medical device approval process.

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Types of 510(k) Application

There are 3 types of 510(k) applications that can be submitted to the US FDA for device evaluation and approval.

  • Traditional 510(k) – Manufacturers can opt to submit a Traditional 510(k) application for any original 510(k) or for a change to a previously cleared device under 510(k).
  • Special 510(k) - Manufacturers can make a Special 510(k) submission, when a 510(k)-cleared device has been modified after the notification if the modification does not affect the intended use or does not alter the fundamental scientific technology of the device.
  • Abbreviated 510(k)- Manufacturers can make an Abbreviated 510(k) submission, when device guidance documents are available, and a special control is established for the device.

Apart from these approaches, FDA also has a ‘Quality in 510(k) Review Program Pilot’ (“Quik”) program. It is an alternative method for preparing a 510(k) application through the FDA’s e Submitter software, which is piloted for a selected list of device types, mainly for moderate risk devices.

To assist manufacturers to fulfil 510(k) submissions requirements and 510(k) medical device approval, Freyr provides support in compiling the device information for the submission, via e-submission platform, along with needed assistance in examining substantial equivalence to predicate device.

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Streamlined FDA 510(k) Submission Services

Our dedicated team of Regulatory experts is here to support you throughout the FDA 510(k) submission process. We understand the critical importance of meeting all the necessary requirements for a successful submission. Let us guide you through the complex Regulatory landscape, ensuring your submission meets the FDA standards.

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Expert FDA 510(k) Consultants at Your Service

Our experienced FDA 510(k) consultants are available to provide expert guidance and assistance. We stay up to date with the latest FDA regulations and requirements, ensuring that your 510(k) submission is accurate and comprehensive. Count on our consultants to navigate the intricacies of the FDA process and maximize your chances of 510(k) clearance.

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Simplifying De Novo Submissions

If your medical device does not have a predicate device for comparison, we offer specialized support for De Novo submissions. Our team understands the unique challenges involved and will assist you in preparing a robust submission package. We ensure that your device receives the appropriate Regulatory classification for a compliant and quick market entry.

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Efficient FDA Registration for 510(k)

Our services include efficient FDA registration for your 510(k) submission. We handle the intricate process of FDA registration to ensure compliance with all the Regulatory requirements. Our team of Regulatory experts will take care of the paperwork while you focus on developing your innovative medical device.

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FDA Third Party Review Program: Accelerating FDA 510(k) Decisions

For over a decade, Freyr has been a trusted partner for the FDA 510(k) consulting services. Our team of experienced consultants specializes in providing comprehensive guidance and support throughout the FDA 510(k) clearance process.

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Software as a Medical Device (SaMD) Registration in USA

Determining the Software as a Medical Device (SaMD) classification for your software is an important step in the registration process. Seeking SaMD consulting services can provide expert guidance in navigating the complexities and ensuring a successful registration outcome.

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Statement of Work (SOW) for Active & Non-Active Medical Device 510(k) Submission

Our experienced FDA 510(k) consultants are available to Statement of Work (SOW) for 510(k) submissions, tailored to both active and non-active medical devices. At Freyr, we understand that the 510(k) clearance process can be complex and demanding, often requiring meticulous attention to detail and adherence to ever-evolving FDA regulations Count on our consultants to navigate the intricacies of the FDA process and maximize your chances of 510(k) clearance.

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Freyr's Approach to Medical Devices Expertise and Advantages

  • Comprehensive US FDA Regulatory strategy
  • Predicate Device Identification
  • Establishing Substantial Equivalence with Predicate Device
  • Gap Analysis for US FDA Compliance
  • Compilation of 21 sections of 510(k) Technical File
  • Publishing and creation of eCopy
  • Validation and submission of eCopy
  • Liaising services for Device Approval
  • Addressal of RTA response and deficiencies
  • Consultation services for addressing deficiencies
  • Device Listing & FURLS database maintenance
  • Have handled many 510(k) registrations of diversified device categories
  • Expert team for 510(k) compilation as per US FDA Premarket Notification (510(k)) requirements
  • Additional support to handle 510(k) queries
  • Advice for the suitable type of 510(k) as per US FDA 510(k) submission requirements for the device 
  • On-time submission of deliverables
  • Up to date with US FDA new amendments