510(k) Submission Services
The 510(k) pathway is a process that medical device manufacturers use to gain clearance from the FDA to market their products in the US. This involves submitting a premarket notification to the FDA, which includes details about the device’s design, performance characteristics, and intended use, and how these compare to a previously cleared “predicate device.”
The goal of a 510(k) submission is to demonstrate that the new device is “substantially equivalent” to a predicate device that has already been cleared by the FDA and is commercially available. The FDA then reviews this submission to confirm this equivalence and to ensure that the device functions as intended.
Once the FDA has confirmed that the new device is substantially equivalent to the predicate, they issue a clearance letter. This allows the manufacturer to market the device in the US. It’s important to understand that a 510(k) clearance is not the same as FDA approval, but rather it indicates that the device is similar to an existing device on the market.
The standard fee for a 510(k) submission is $21,760, with a reduced fee of $5,440 for small businesses.
Defining Substantial Equivalence
A key part of a 510(k) submission is demonstrating substantial equivalence to a legally marketed device in the US. This means that the new device is just as safe and effective as the predicate device.
A device is considered substantially equivalent if it has the same intended use as the predicate and has the same technological characteristics, or if it has the same intended use but different technological characteristics that do not raise different questions of safety and effectiveness. The information submitted to the FDA must show that the device is as safe and effective as the legally marketed device.
It’s important to note that substantial equivalence does not mean that the new device has to be identical to the predicate device. The FDA assesses whether the intended use is the same and evaluates any differences in technological characteristics to ensure they do not raise new safety or effectiveness concerns. This evaluation includes a review of scientific methods used to assess differences and performance data, such as clinical and non-clinical bench testing, sterility, software validation, biocompatibility, etc.
If the FDA determines that the device is not substantially equivalent, the applicant has several options, including resubmitting a 510(k) with new data, pursuing a De Novo Classification for Class I or II designation, filing a reclassification petition, or submitting a premarket approval application (PMA).
Types of 510(k)s
There are three types of 510(k)s: Traditional, Abbreviated, and Special. It’s important to understand the qualifications for each type to choose the appropriate pathway.
- The Traditional 510(k) pathway is used for new devices that haven’t been cleared before and don’t need to undergo the PMA (Pre-Market Approval) process. It’s also used when changes are made to a previously cleared device that doesn’t meet the criteria for a Special 510(k). For this pathway, it’s essential to identify predicate devices concerning their indications for use and technological features.
- The Abbreviated 510(k) program was created as an alternative to the traditional path. Manufacturers can submit an Abbreviated 510(k) when their submission relies on FDA guidance documents, demonstrates compliance with special controls for the device type, or conforms to voluntary consensus standards. An Abbreviated 510(k) submission includes the same sections as a Traditional 510(k), but manufacturers can enhance their submission with summary reports regarding guidance documents, adherence to special controls, or conformity to recognized standards to showcase substantial equivalence. While the Abbreviated pathway may not necessarily involve less effort, it can be a viable option when proving equivalence to a standard is simpler than using a predicate device. The review period for an Abbreviated 510(k) is typically around 90 days, although it might take longer than a Traditional 510(k) in some cases.
- The Special 510(k) is a regulatory pathway designed for changes made to a manufacturer’s own legally marketed predicate device that is already authorized for commercial distribution. The recent update to the Special 510(k) guidance allows for the review of changes that affect a device’s intended use or alter its fundamental scientific technology, whereas such changes were previously not allowed under this pathway.
Review Process and Timeline for 510(k) Submission
The process for a 510(k) submission involves several steps:
Here is the FDA reviewing Timeline:
Day 1 | Within 7 days | By day 15 |
FDA receives the 510(k) application. | The FDA will issue an Acknowledgement Letter or a Hold Letter in cases where there are concerns regarding user fees or the submission of an eCopy. | The FDA performs an Acceptance Review where they assess the 510(k) submission. Following this review, the FDA informs the applicant whether their 510(k) has been accepted for Substantive Review or placed on RTA (Refuse to Accept) Hold. |
By day 60 | By day 90 | By day 100 |
The FDA conducts a Substantive Review. They then communicate a Substantive Interaction to the applicant, indicating whether the FDA will move forward with an Interactive Review or request Additional Information. | The FDA sends the final MDUFA Decision on 510(k). | If a MDUFA (Medical Device User Fee Amendments) Decision is not reached by the 100th day of review, the FDA issues a Missed MDUFA Decision Communication. This communication identifies any remaining review issues that need to be addressed. |
Who Needs to Submit a 510(k)?
The FD&C Act and the 510(k) regulation (21 CFR 807) do not specify who must submit a 510(k). Instead, they specify which actions, such as introducing a device to the U.S. market, require a 510(k) submission.
The following four categories of parties must submit a 510(k) to the FDA:
Manufacturers based in the U.S. who introduce devices to the U.S. market, particularly if they create and market devices based on their own specifications. Additionally, accessories sold to end users are treated as finished devices and need a 510(k) submission. However, manufacturers of device components are exempt unless these components are sold as replacement parts to end users. Contract manufacturers, producing devices based on others’ specifications, are also exempt. Specification developers launching devices in the U.S. market. These developers design device specifications but have them manufactured under contract. They are responsible for the 510(k) submission, not the contract manufacturer. Repackers or relabelers altering device labels or conditions may require a 510(k) submission. Most are exempt, but significant changes like adding new uses or altering warnings may necessitate a submission. Foreign manufacturers/exporters or their U.S. representatives introducing devices in the U.S. market must also submit a 510(k) to the FDA. Furthermore, it’s essential to note that all manufacturers, including specification developers, of Class II and III devices, as well as select Class I devices, must adhere to design controls during the development of their devices. This includes having design control documentation available for FDA review during inspections. Any changes to device specifications or manufacturing processes must comply with the Quality System regulation (21 CFR 820) and may necessitate a new 510(k) submission.
When is a 510(k) Required?
Unless exempt, if you are introducing a device into commercial distribution for the first time, you must make a 510(k) submission at least 90 days before offering the device for sale. This requirement applies to devices marketed after May 28, 1976, regardless of whether they were in development or undergoing clinical investigation before that date. If your firm did not market the device before May 28, 1976, a 510(k) submission is necessary.
Additionally, if there is a change or modification to a legally marketed device that could significantly impact its safety or effectiveness, the 510(k) holder must determine whether the modification is significant. This decision must consider compliance with the Quality System regulation (21 CFR 820) and be documented in the device master record and change control records. It’s advisable to record the rationale for submitting or not submitting a new 510(k) in the change control records.
What Should be Included in a 510(k) Submission?
The current eSTAR 510(K) electronic submission requested the information below:
Submission Type Cover Letter/ Letter of Reference Applicant Information Pre-Submission Correspondence & Previous Regulatory Interaction Consensus Standards Device Description Proposed Indication for Use Classification Predicates and Substantial Equivalence Design/Special Controls, Risks to Health, and Mitigation Measures Labeling Reprocessing Sterility Shelf Life Biocompatibility Software/ Firmware Cybersecurity/ Interoperability Electromagnetic Compatibility (ECM), Electrical, Mechanical, Wireless and Thermal Safety Performance Testing References Administrative Documentation Amendment/ Additional Information (AI) response.
Why Choose Us?
When it comes to navigating the complexities of the 510(k) submission, our team stands out for its depth of experience and commitment to client success. We have a proven track record of helping companies achieve FDA clearance for their medical devices. Our approach integrates technical, clinical, and regulatory expertise, enabling us to overcome challenges and expedite your time to market. We understand the intricacies of the 510(k) process and can guide you through every step, from preparing your submission to responding to FDA inquiries. Plus, we offer translation services for key documents, ensuring you have all the information you need in a language you understand. Choose us for your 510(k) needs and experience the difference that our knowledge, experience, and client-focused approach can make.
About Accel
Accel Groups is a dedicated team of seasoned professionals in regulatory, clinical and market access. We help medical device and IVD manufacturers with complete product life cycle solutions from preclinical, strategy, clinical evaluation and trial, regulatory submission, to post market surveillance. Our regional principals have a minimum of 10+ years’ experience in their specialty to enable us to provide the regional in-depth expertise but with global one-stop shop solutions. Ask us about our Start-up kits for start-up companies with key countries regulatory pathway.
