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FDA 510(k) Submissions

Complete your 510(k) submission or PMA (Premarket Approval) application accurately and efficiently with Oriel STAT A MATRIX’s expert guidance.

FDA 510(k) Consulting

FDA sends back most 510(k) submissions during the first review cycle to request more information. In recent years, this has applied to more than 70% of 510(k) submissions!  

Oriel STAT A MATRIX’s four-phase process to develop your 510(k) submission ensures that you address all the necessary elements, reducing the need for costly rework while increasing the probability of a successful first-time submission.

Our Four-Phase Process to Develop Your 510(k) Submission

Phase 1: Perform a Pre 510(k) Gap Analysis

  • Evaluate the classification of your medical device or IVD and determine the proper FDA product code and regulation number.
  • Identify any predicate devices that are suitable for use in your 510(k) submission.
  • Review testing requirements, applicable FDA guidance documents, and required standards.
  • Create a detailed product-specific list of the necessary review documents.
  • Develop a list of the documents, reports, specifications, or clinical data needed to prepare the 510(k).
  • Prepare a technical comparison of your medical device to cleared predicate devices.
  • Provide a detailed gap analysis report. This report will show you what information you possess and the data you still need to collect for a successful 510(k) submission.

Phase 2: Guided Review of 510(k) Requirements

  • Coach and educate your team on expected and needed testing requirements.
  • Collect the needed data identified in the gap analysis.
  • Document and/or revise test data results in a manner that is easily understood by FDA.
  • Review quality system components needed for compliance.*

Phase 3: Compile and Submit the FDA 510(k) Application

  • Prepare all 20 sections of the FDA 510(k) application.
  • Coordinate the payment of the FDA 510(k) submission fees on your behalf.
  • Submit the 510(k) to FDA.

Phase 4: Provide Postsubmission Support

  • Answer any follow-up questions from the FDA reviewer via Additional Information requests.
  • After FDA clears the device, guide you through the Establishment Registration and medical device listing process.
  • Provide continued support for quality system implementation and compliance.*

* Companies commercializing a medical device in the US must implement a quality system that is in accordance with FDA Quality System Regulations - QSR 21 CFR Part 820.

We can conduct a baseline assessment of your current system so you have a clear picture of its current compliance level against FDA’s QSR, and then we will create a roadmap you can follow to implement any corrective action needed to comply with the regulations – before submitting your 510(k) package to FDA for approval.   We can also help you establish a quality management system that complies with FDA's QSR and/or ISO 13485.

FDA 510(k) – Frequently Asked Questions

What is a 510(k) submission?

The term 510(k) refers to the section of the Food, Drug, and Cosmetic Act that requires a Premarket Notification for moderate-risk devices before they can be placed on the market. This term is now commonly used to refer to a submission or application that is a compilation of documentation supporting the safety and efficacy of a medical device.

The 510(k) process is the most commonly used regulatory pathway for new medical devices or for modifications made to medical devices that have already been cleared by FDA. It allows manufacturers to bring new and/or modified products to market based on demonstrating substantial equivalence to a previously cleared device (called a predicate device) that FDA has already cleared for sale in the US market.

Who must submit a 510(k)?

All companies bringing a new or modified product to market in the US need to register their product with FDA. Most Class I devices (low risk) can be self-registered, but most Class II devices (moderate risk) require a 510(k) submission. For Class III devices, a premarket approval (PMA) submission is needed. Visit the FDA website to find out more about Class I and Class II requirements.

How do I determine my device’s classification?

FDA uses a risk-based system to classify medical devices as Class I, II, or III based on increasing risk to a patient. The classification is determined by a regulatory definition that is available on the FDA website and can be applied to all medical devices.

  • Class I devices are low risk. Most are exempt from Premarket Notification 510(k) submission and are only required to be listed with FDA. Examples include tongue depressors, arm slings, and some hand-held surgical instruments.
  • Class II devices are designed to perform as indicated without harming patients or users, but they require a greater level of safety and effectiveness assurance than do Class I devices. Class II devices are generally more complex and higher risk than Class I devices. Examples include powered wheelchairs, infusion pumps, surgical drapes, surgical needles, suture material, and acupuncture needles.
  • Class III medical devices do not have enough information to ensure safety and effectiveness through the general or special controls used for Class I or Class II devices. These higher-risk devices need premarket approval (PMA), which includes a scientific review, to ensure their safety and effectiveness. Examples include replacement heart valves, silicone gel-filled breast implants, implanted cerebral stimulators, and implantable pacemaker pulse generators.

What is included in the 510(k) submission?

The premarket notification submission is extensive and can run from hundreds to thousands of pages. You will need the following information to prepare a 510(k) submission:

  • Classification of the device
  • Identification of predicate device(s) suitable for use in your 510(k) submission
  • A technical comparison table of your medical device to the cleared predicate device(s) that shows the similarities and differences between the subject device and the predicate device(s)
  • Final draft labeling, including device labels and instructions for use
  • Specifications, including engineering drawings, dimensions, composition, etc.
  • Sterilization information (if applicable)
  • Biocompatibility information (if applicable)
  • Electrical safety testing (if applicable)
  • Complete description of the software specifications and architecture (if applicable)
  • Performance data, such as bench, animal, or clinical testing (if applicable)

Many device manufacturers find it helpful to ask an external resource to evaluate their existing documentation and identify gaps they need to address for a successful 510(k) submission.

Options when a 510(k) is not the appropriate pathway for your product

Premarket Approval (PMA)

The PMA process is used for Class III life-supporting and/or life-sustaining devices that pose a greater risk of harm to patients and users. Such products may also be new, novel medical devices that do not have a predicate device to which the manufacturer can claim substantial equivalence. To obtain FDA approval for a Class III device, the manufacturer typically must conduct human clinical trials to demonstrate the safety and effectiveness of the product.

De Novo process

Entirely new devices are automatically considered to be Class III in the US. However, many new products do not pose a high risk for patients. For such products, FDA has the De Novo process to bridge submission requirements for moderate- to low-risk medical devices. You may consider filing a De Novo submission if the FDA determines, through means such as a 513(g) classification or Q-Submission meeting, that your product is a “novel” device with no existing classification or predicate device on the market. The most important factor in such cases is that this classification as a new, novel device has determined that the device’s benefit-to-risk evaluation poses moderate to low risk to a patient.  A De Novo process allows a submission process that is not as burdensome as a PMA.

Within 120 days after your De Novo submission, FDA will determine if your device is Class I or II and may issue an entirely new product code and regulation number. If rejected, your device will remain Class III. 2014 De Novo guidance document from the FDA

513(g) submission

If your device is difficult to classify due to new technology and intended use, you may need to submit a formal classification request – a 513(g) “Request for Information” – to FDA. The 513(g) submission should outline the characteristics of your device and include an explanation and rationale of why you believe it falls into a specific class.

FDA will evaluate your information in approximately 60 days and issue a ruling on how your device should be classified, along with a suitable regulation number and product code. FDA 513(g) guidance document

The role of the quality system requirements

A quality system is a formalized, documented collection of business processes describing how your devices are produced according to specifications, the instructions that are followed to ensure accurate manufacturing, and the steps that will be taken if a product is defective or requires improvements.

No matter which regulatory pathway is required for your device, companies commercializing a medical device in the US must implement a quality system that is in accordance with FDA’s Quality System Regulations (QSR). A quality system is required to be established and implemented because the FDA performs routine inspections of medical device manufacturers and, during these inspections, expects compliance to the QSR.

How long will it take FDA to respond to my 510(k) submission?

FDA’s goal is to issue a decision within 90 “FDA days.” The clock starts when FDA receives the 510(k) submission and filing fees,  but FDA pauses the clock if they need to request additional information from your company. The typical calendar time can vary from 90 to 180 days. At the end of the review, FDA will issue a substantially equivalent or not substantially equivalent decision. A substantially equivalent decision means the device is cleared to enter the market.

Potential 510(k) pitfalls

FDA sends back most 510(k)s during the first review cycle in order to request more information – in recent years this has applied to more than 70% of 510(k) submissions!  

The first step performed by FDA is an administrative review called “Refuse to Accept,” which can cause significant delays in the submission process. A need for more information halts the FDA review, but this is preventable. Use the available 510(k) submission checklist and consider asking an objective party to review the submission for completeness before sending it to FDA.

Failing to establish substantial equivalence will prevent FDA from clearing your device. You can minimize this risk by consulting with submissions experts who can help you evaluate the relative strengths and weaknesses of your substantial equivalence arguments and the overall submission.

Select a course below to learn more or to register.
Course Name Public On-site
US FDA 510(k) and EU CE Marking Medical Device Registration Strategy Training

Learn how to identify an appropriate regulatory pathway to obtain product approval or clearance in the United States and/or the European Union (EU). Click to learn more.

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