When manufacturers plan to launch a medical device into the United States market, one of the most crucial steps is obtaining FDA clearance. To get that clearance, applicants must demonstrate to the Food and Drug Administration (FDA) that their device is safe and effective. Medical devices usually require either FDA clearance, aka premarket notification (PMN) or FDA Approval aka premarket approval (PMA).
Which devices call for a 510k submission vs which need PMA? The answer depends on FDA’s guidelines for medical device classification.
How the FDA Classifies Medical Devices
Under FDA guidelines, all medical devices fall under three categories, generally corresponding to the device’s risk profile.
Class I includes simple, minimal-risk devices. These medical devices comply with general regulatory controls and usually do not require premarket submissions. Examples of Class I devices include examination gloves, electric toothbrushes, and elastic bandages.
Class II devices may involve small to moderate risks to the user. These type of devices requires a 510k submission before entering the market. Devices of this class include items like powered wheelchairs, intravenous kits, and some pregnancy testing kits.
Class III includes mainly implanted or life-sustaining high-risk devices that could cause significant harm to patients in case of a malfunction. Class III devices include implantable pacemakers, cochlear implants, and renal stents. All devices of this class require premarket approval before marketing.
510k vs PMA Applications: The Main Differences
510k submissions for Class II medical devices and PMA for Class III devices use different regulatory processes. In a nutshell, since Class III devices are crucial for patients’ health and life, the FDA applies far stricter regulations to this type of medical device.
Class II devices are seldom completely innovative. The main goal of a 510k submission is proving to the FDA that the device is essentially equivalent to a similar predicate device that the FDA has already cleared for marketing.
For example, if a company plans to market a new blood pressure cuff, this device may offer several advantages over existing products, but its core functions are still similar to other blood pressure cuffs. The legal term for this similarity is “Substantial Equivalence” (SE). A 510k submission should demonstrate substantial equivalence by comparing the applicant’s device to an approved predicate device.
510k submissions typically require laboratory testing, but not human testing. The submission form normally includes information like device characteristics, intended use, and indications for use.
The processing time for 510k submissions is usually within 30 to 90 days. If FDA accepts the application, they will post the submission to the FDA 510k database.
It’s vital to note that a successful 510k submission means that a device is FDA-cleared rather than FDA-approved. Using the correct legal terminology is important to prevent medical litigation.
PMA submissions must comply with far more rigorous standards compared to 510k to prove device safety and effectiveness. Typically, Class III devices require both laboratory testing and clinical trials that include human participants. The FDA usually processes PMA applications within 180 days.
De Novo Applications
A minority of low-risk devices introduce completely original processes or functions that disqualify them from approval based on substantial equivalence to a predicate device. These devices, while not presenting a significant risk to the user, may not get FDA clearance through a 510k submission.
Manufacturers of novel low-risk devices can submit their products for FDA approval using the de novo process, which assigns a proper classification to the device. Devices cleared for marketing through this pathway may function as predicates for future similar products.
How to Avoid Potential Problems with FDA Clearance Submissions
To get a medical device to the U.S. market as fast as possible, applicants need to ensure a snag-free 510k clearance process. Many companies face delays in getting 510k clearance because of several common and preventable errors.
Here are a few examples of mistakes that could cause delays or lead to FDA refusing to accept a 510k submission.
Inconsistent documentation, such as an imprecise restating of the intended use statement or mix-ups between indicated use and intended use
Failure to comply with FDA guidance documents such as the RTA (Refuse to Accept) checklist
Insufficient testing, such as not providing the results of biocompatibility tests or not including sufficiently detailed results, reports, or protocols
Poor risk management documentation, such as failure to demonstrate a product’s safety
Failure to demonstrate substantial equivalence and show that a medical device is sufficiently similar to existing FDA-cleared devices
Incorrect formatting of the submission, including file name and size
Medical device manufacturers can maximize their chances of obtaining 510k clearance on the first attempt by:
making sure to complete all the sections required by FDA including the Refuse to Accept checklist
completing all testing before submission, including all necessary data and protocols
providing an accurate comparative analysis of a predicate device
Even the most complete and thorough submission forms may bring forth follow-up questions from the FDA. If this happens, applicants should review the questions thoroughly and make sure to provide concise strategic responses.
How Essenvia Can Help With 510k Submissions to get FDA Clearance
Technical hiccups at the 510k clearance stage can cost manufacturers a lot of time, frustration, and money. An unexpected rejection of a 510k application could delay a marketing campaign or stall negotiations with vendors. In some cases, a competitor could cut in and launch a similar product earlier simply because they got their 510k submission processed more quickly.
Essenvia is here to help manufacturers get their medical devices to market as quickly and efficiently as possible. Essenvia’s platform streamlines regulatory application processes for 510k clearance and MDR submissions, ensuring speed and accuracy with collaboration built-in.
Essenvia can save over 40 work hours, which companies can invest in more important tasks like product development, testing, and marketing. The secure, easy-to-use platform includes up-to-date templates, collaborative authoring, and one-click publishing.
Essenvia: Simplifying FDA Applications
Regulatory agencies like FDA reject more than one-third of medical device applications due to technical errors like omissions and inaccuracies. Essenvia’s 510k Application Builder streamlines FDA applications by offering the latest templates, seamless collaboration, and more across the entire life cycle of the medical device.
Complete your 510(k) or MDR application and launch your device faster with Essenvia. Schedule a demo now to find out how Essenvia can help you with your regulatory submissions.