Contact
Call Us

Introduction To The 510(k)
Process And FDA Regulations

For over 20 years, Empirical Technologies has been providing valuable expertise into various aspects of regulatory compliance, which includes hundreds of 510(k) submissions and clearances. With a long-standing relationship with the FDA and an impeccable track record of success in submission clearance, we’re proud to assist clients as they navigate the 510(k) submission process.

Request an Estimate
As 510(k) FDA submission consultants, some of the services we provide include evaluating your medical device’s classification, performing GAP analysis, providing advice on testing and technical expectations for quick 510(k) submissions, and collecting the necessary data and documentation to complete the 510(k), among others. We aim to remove the stress and burden of 510(k) submissions from your shoulders by bringing skill and dedication as FDA 510(k) consultants to the partnership, so you can enjoy a more seamless experience with desirable outcomes at the end of the submission process.

WHAT IS A 510(K)

The Food and Drug Administration (FDA) maintains responsibility for ensuring that all cosmetics, food, pharmaceuticals, and medical devices meet specific standards to ensure their safety for American consumers. The 510(k) is the Premarket Notification submission of a medical device submitted to the FDA and reviewed by their Center for Devices and Radiological Health.
A number of different phases of review will occur once a 510(k) has been submitted. A thoughtful, thorough presentation crafted by an experienced 510(k)-specialized regulatory consultant receives a far more expedient FDA review and decision with minimized delays from Administrative or Refuse to Accept (RTA) holds requiring more content, or Deficiency Holds requiring additional testing, analysis, or justification of substantial equivalence.

What Is The Purpose of

The 510(k) Clearance Process

The 510(k) clearance process ensures that a medical device meets safety requirements and performs effectively compared to similar devices on the market. If your device is not at the highest level of risk and does not need a Premarket Approval application (PMA), you will likely need to submit it for FDA clearance through the 510(k) submission. Once adequate tests have been identified, run, and reported, Empirical Technologies will help you submit the information to the FDA.

Upon receiving the submission, the FDA first completes the Administrative Review to ensure all required content is present for them to perform an exhaustive review. If not all information is included in the submission, the FDA may issue an Administrative Hold or Refuse to Accept (RTA) Hold and require the missing information to be submitted. If the FDA can move from the Administrative Review into the Substantive Review of the submission without an Administrative Hold, they will either issue clearance at the end of that review phase or can issue a Deficiency Hold for you to address any concerns or questions they have with the submission packet, testing data, and technical information.

Perhaps the most convincing reason to utilize our fast 510(k) FDA submission consultants is simply the fact that we have a 100% success on submissions which have the testing and technical information we recommend to our clients. There’s no reason to struggle through the technical, complex process of submitting your 510(k) to the FDA on your own; Empirical Technologies understands what it takes to succeed on this front, and we want to apply our skills to help you.

Overview of FDA Regulations

For Medical Devices

The FDA regulates firms that manufacture, repackage, relabel, and/or import medical devices sold in the US. Medical devices fall under Class I, II, and III classifications depending on risk levels associated with the device with Class III being the most highly regulated devices. Many Class I devices do not need the Premarket Notification 510(k) submission, while most Class II devices require it. Most Class III devices always need Premarket Approval.

Medical devices must comply with the following requirements:

Manufacturers (foreign and domestic) who market their devices in the US and initial distributors (importers) must register with the FDA unless granted a waiver by the FDA.

Manufacturers, contract manufacturers, contract sterilizers, repackagers and relabelers, specification developers, reprocessors of single-use devices, remanufacturers, manufacturers of accessories and components sold directly to the end user, and U.S. manufacturers of “export only” devices all must list their devices in their FDA registrations.

According to US regulations, these medical devices cannot be commercially distributed until the FDA reviews the 510(k) submission for the subject device and provides a letter of substantial equivalence. Requirements vary depending on the Class and regulation type of the device. Premarket Approval devices fall under Class III, which means they pose a significant risk of injury or illness.

For medical devices that require clinical data and a PMA review, or for medical devices that fall within the 510(k) but still require clinical data investigational devices, which are devices permitted for use in a clinical study by the FDA to obtain data on the safety and effectiveness of the device but are not yet fully reviewed by the FDA and not yet cleared or approved to market in the US, such devices must have an approved IDE before the study starts. Only studies approved by the FDA and an Institutional Review Board (IRB) can take place.

Facilities designing, purchasing, manufacturing, packaging, labeling, storing, installing, and servicing medical devices require compliance with US Quality System Regulations and are subject to FDA inspections to ensure operation and control according to the quality management system.

Certain information must be prominently displayed on medical devices on both the container and its box/wrapper along with other written, printed, or graphic matter.

Anytime a device may have caused death or serious injury, it must be reported to the FDA under the Medical Device Reporting program. The MDR helps the FDA and manufacturers identify and monitor events using medical devices in order to detect and correct problems promptly.

Comparison To Other

Regulatory Pathways

For Medical Devices

Empirical Technologies’ consultants have assisted more than 200 successful, quick 510(k) submissions and are confident and competent to generate and handle complete 510(k) submissions according to the FDA’s expectations and specifications. Though the average number of review days required to receive FDA clearance hovers around 177, the average review days for 510(k)s submitted by Empirical is under 120. Our record of success has not been achieved by sheer luck—we work hard to set ourselves apart as an FDA fast 510(k) consulting firm that redefines industry standards.

TYPES OF MEDICAL DEVICES
THAT REQUIRE A 510(K)

The FDA bases its regulatory class on the level of control needed to ensure the safety and effectiveness of the medical device. For the 1,700 different generic types of devices, the FDA grouped them into 16 medical specialties they call panels. Devices get classified according to their intended use and the indications for use.

Classification of Medical Devices

By Risk Level

To determine which class your device belongs in, we’ll take the following steps:

1.

First, we’ll talk with you to determine the intended use of your medical device and if it’s designed to treat, cure, mitigate, or prevent specific conditions, injuries, or diseases.

2.

Next, we determine if any exemptions from PMA or 510(k) submission requirements exist for the product by determining the regulation number that classifies the medical device. To find the regulation number, we either search for the device name in the classification database, or check the device panel (medical specialty) where your device belongs.

3.

Once we determine the correct regulation number for the device, we can identify cleared devices in that regulation which we will use for comparison to show substantial equivalence in our 510(k) submission. If needed, we can get formal device determination from the FDA by sending in a 513(g) Request, which incurs a user fee that small businesses may be able to reduce if they qualify.

4.

Finally, we figure out the next steps needed to get your device to market! That is, we determine the regulatory pathway, the testing requirements, and the technical information needed by the FDA for the submission.

Classification Levels

Devices in Class I pose the least threat of all the levels to both the patient and the user.

With exemptions – Nearly 74% of Class I devices do not need a premarket notification.

Without exemptions – The remaining 26% will need a premarket notification.

With risks on a level between those of Class I and those of Class III, about 43% of medical devices belong in the Class II category.
Devices that fall into this category have risks that can result in serious injury or death of the patient. They require a PMA submission.

Examples of Medical Devices

from each Class

Most Class I devices do not need a 510(k), and some Class II devices remain exempt as well. Most Class III devices require a PMA. This list does not include all the devices included in each category:

Class I examples:

  • Bandages
  • Bedpans
  • Electric Toothbrushes
  • Handheld Surgical Equipment
  • Hospital Beds
  • Non-Electric Wheelchairs
  • Oxygen Masks
  • Stethoscopes
  • Surgical Masks
  • Tongue Depressors

Class II examples:

  • Absorbable Sutures
  • Catheters
  • Computed Tomography (CT) Machines
  • Infusion Pumps
  • Electric Wheelchairs
  • Pregnancy Test Kits
  • Surgical Gloves
  • Syringes

Class III examples:

  • Breast Implants
  • Cochlear Implants
  • Defibrillators
  • Pacemakers
  • High-frequency Ventilators
  • Implanted Prosthetics

FDA 510-K SUBMISSION PROCESS

1.

Upon receiving all documentation and testing data, we draft and submit a 510(k) to the FDA.

2.

When received, the FDA assigns the submission a unique control number (aka the 510(k) number/K number). The first two digits state the year of the submission, and the last four represent the submission number for the year starting with 0001. For example, the first 510(k) submission received by the FDA in 2023 would be K230001. An Acknowledgement Letter is sent to the submission’s primary contact person confirming that the FDA has received the submission and will begin the review.

3.

After the FDA verifies that the sponsor of the submission paid their submission and sends the Acknowledgement Letter of the submission’s receipt, the submission is sent to the appropriate Review Panel. Management from the Review Panel will assign a lead reviewer for the submission review. That lead reviewer then begins with the Administrative Review to determine if the content in the submission is sufficient for the FDA to conduct a substantive (or exhaustive) review.

  • If the FDA, during their Administrative review, determines that the submission lacks sufficient technical information or test reports for them to evaluate substantial equivalence, the FDA emails a hold letter to the submitter, usually within 15 days of receiving the submission, to request the missing information be provided. The user has 180 days to resolve issues with the submission or the 510(k) gets withdrawn and deleted. A new 510(k) must be submitted for the FDA to review the device.

4.

For a submission that passes the Administrative Review, the FDA sends an email update to the submission’s primary contact person to indicate that the Substantive Review phase is beginning.

5.

The lead reviewer will do a thorough review of the submission and reach out to primary contact by day 60 to communicate if the review can be finished through interactive (or email) discussion with the sponsor or if the reviewer needs to place a Deficiency (Additional Information) Hold on the submission to address any outstanding issues.
  • Interactive Review – If issues can be addressed by email and a final decision can be made by Day 90 (within the Medical Device User Fee Amendment (MDUFA) timeframe without being placed on hold) the lead reviewer will conduct the interactive review through email or call the submitter.
  • Additional Information (AI) – Should the reviewer issue a Deficiency or AI Hold, the submission gets placed on hold. The sponsor has 180 days to respond with the information to address the deficiencies; if the sponsor fails to submit an AI Response within 180 days, the FDA will cancel the submission, and a new 510(k) must be submitted for the FDA to review the device.

6.

Upon receiving the AI Response, the FDA has approximately 30 days to review the additional information and to make their final clearance decision. The FDA aims to fulfill Medical Device User Fee Amendment (MDUFA) decisions within 90 days from the day they initially received the submission, excluding days a submission was on hold an administrative deficiency or for an AI request. They will identify the device as substantially equivalent (SE) or not substantially equivalent (NSE) to other devices in the same classification and category at the conclusion of their review.

7.

The submitter will receive an email to the address listed in the 510(k) submission stating if the device was “cleared”.
  • If the device cleared the process, the FDA adds it to their 510(k) database, which gets updated weekly. They include the IFU (Indications For Use) statement and the 510(k) Summary or 510(k) Statement, which get included in the SE letter in the FDA’s online 510(k) database.

Special 510(k)

Special 510(k) requests apply to sponsors who already own a legally marketed device, but want to modify it, change the intended use, or change the labeling. The modified device needs to produce substantial equivalence (SE) to its predecessor based on reliable data, and validation reports must be provided in a summary or risk analysis format.

The FDA will look at design control procedures to evaluate if the change(s) are well established and if they can be sufficiently reviewed. They intend to finish the whole process in 30 days compared to the typical 90 days for traditional 510(k)s.

Designs that can be considered appropriate for a Special 510(k) must meet specific requirements:

  • The proposed changes are made by the entity who is legally authorized to market the device.
  • If the FDA will need performance data, there must be a well-established method to evaluate the change. Some changes do not need this performance data.
  • All the validation data for SE can be reviewed in a summary or risk analysis format.
All the validation data for SE can be reviewed in a summary or risk analysis format.

510(k) FDA

Required Sections

Checklists for 510(k) submissions cover several different areas. The FDA provides electronic access to these documents so that you can view them ahead of time to know what to expect. At Empirical Technologies, our FDA regulatory consultants and FDA compliance consultants have submitted hundreds of cleared 510(k) submissions quickly and successfully gotten our clients devices to market 20-30% faster than industry standards.

510(k) applications require the following sections:

  • A cover letter
  • Statements for indication of use
  • A 510(k) statement signed by the certifier
  • Evaluation of the device’s sterility, packaging, and shelf-life
  • Evaluation of the device’s biocompatibility
  • Evaluation of performance – bench testing
  • Evaluation of Software Use (if applicable)
  • Evaluation of electrical safety (if applicable)
  • Evaluation of performance – animal testing (if applicable)
  • Evaluation of performance – clinical testing (if applicable)
  • The proposed labeling for all aspects of the device with any warnings, contradictions, or limitations
  • A truthful and accurate statement saying no material facts were omitted
  • The device's specifications:
  • A narrative description of the indications for use, principles of operation, power source, composition and other information necessary to understand the device. This also includes descriptions of how accessories or components will be used and lists all the variations of the “new” device.
  • A physical description of the whole device and any parts intended for single use using schematics, labeled diagrams, photographs or pictures, engineer drawings, etc.
  • A Predicate Comparison of the subject device to similar cleared predicates looking at some of the following characteristics including the design, intended use, energy used/delivered, performance, materials, safety, effectiveness, and other characteristics, like sterility.

International Process
Brief Overview

Foreign manufacturers may apply for 510(k) directly with the FDA. To market their product in the US, foreign manufacturers must have a US agent listed on their facility registration. Empirical Technologies frequently serves as the US agent for foreign manufacturers.

Common Issues

That Can Cause Delays or Rejections

  • Inconsistent Documentation regarding indicated use versus intended use

– Intended use is the purpose of a device listed on the label

– Indications for use are the specific conditions the device treats, mitigates, or diagnosis and conditions for which the device may be used

  • Not completing all testing requirements
  • Insufficient shelf life studies that include protocols, results, and reports showing correlation between real-time and accelerated aging data (if applicable)
  • Misunderstanding risk management requirements
  • Not demonstrating equivalence to predicate products

Issues with submission formatting can easily be eliminated by using trusted 510(k) consultants. Get your 510(k) approved quickly with Empirical Technologies!

FDA REGULATIONS FOR MEDICAL DEVICES

Importance of Compliance

With FDA Regulations

Complying with FDA Regulations and submission requirements gets your device to market. If steps get skipped or left undone, the FDA will place holds on the submission reviews and clearance decisions until they are met or until the FDA cancels the submission because 180 days have lapsed since issuing the hold. These issues significantly delay manufacturers from marking their medical devices. Selling a regulated medical device without FDA clearance or approval may lead to legal ramifications.

FDA Approval Process

Of New Medical Devices

With novel/new designs, there may not be an appropriate FDA cleared predicate device to which substantial equivalence can be shown. If no previous medical device fits your specifications, the FDA provides a De Novo track for devices with low to moderate risks. The FDA issued a final rule with criteria for the De Novo classification requests that covers the formatting, required data, and the process for accepting, granting, declining, and withdrawing these requests.

In short, you’ll need to do the following:

1.

Determine that your device does not have a comparable predicate device. The FDA suggests submitting a Pre-Submission to get feedback from the appropriate premarket division.

2.

Include the following components in your request:

  • A cover sheet identifying the 513(f)(2) De Novo request
  • Administrative information like the devices intended use, prescription use, etc.
  • A complete device description of the technology used, proposed conditions of use, accessories, and components
  • Classification Information and Supporting Data that includes quite a few different parts all listed in the final rule

3.

Submit your application online or by mail to the Center for Devices and Radiological Health (CDRH) or the Center for Biologics Evaluation and Research (CBER), as well as to the FDA through a method that provides a signed receipt of delivery. The appropriate center will assign your request a unique document number starting with DEN or BR followed by six digits stating the year and the amount of submissions received that year. For example, the first submission of the year for 2023 would show DEN230001 or BR230001. Within 7 days, the appropriate center will send out an acknowledgement letter.

4.

Determine the fees you owe to the Medical Device User Fee Amendments (MDUFA).

5.

Once the FDA has its information, they will conduct an acceptance review to see if your forms have all the required information. They’ll let you know if the device has been accepted for substantive review, or what pieces need to be amended by issuing a Refusal to Accept (RTA) letter that follows their Acceptance Checklist. If they didn’t finish the acceptance review after 15 days, they’ll let you know an expected timeline to complete it.

6.

Once in substantive review, the FDA will determine if any predicate devices exist to ensure the product meets De Novo requirements. If they need any additional information, they’ll send out an Additional Information Letter that needs to be completed within 180 days.

7.

Within 150 days from submission, the FDA aims to have your De Novo determination completed. New devices will need to be classified as a Class I, II device, must be in compliance with applicable regulations, will serve as a predicate for similar devices, and the FDA will post new information about the device on their website and the Federal Register.

Recommendations For Regulatory Strategy
And Preparation of A 510(k) Submission

While you can do all of this on your own, the FDA and other companies recognize the advantages of utilizing experienced FDA 510(k)-specialized consultants. These trained professionals will help you navigate and expedite the process to make it as painless as possible.

Empirical Technologies’ trusted FDA regulatory consultants will talk with you to gather the needed information and address any missing pieces of your submission ahead of time. Contact us to schedule a consultation today!

Contact Us