FDA submission types for medical devices

Introduction – The FDA may receive several submissions about newly developed or altered medical devices being marketed in the United States. The two most popular forms of market authorization submissions to the FDA to lawfully market a device in the US are the 510(k) premarket notice submission and the PMA premarket approval. The De Novo petition is a less well-known premarket submission, yet it is growing increasingly frequent as new and innovative technology and applications enter the device market. The FDA decides for each of these submission types, clearing [510(k)], approving [PMA], or awarding [De Novo] marketing rights to the successful submitter.

How to Study and Market Your Device – Title 21: Code of Federal Regulations (21 CFR), Parts 1-58, 800-1299, and the Federal Food, Drug, and Cosmetic Act (FD&C Act) provide regulatory requirements that apply to medical devices that are sold in the United States. The risk of the device and the regulatory controls required to provide a reasonable assurance of safety and effectiveness determine the regulatory controls and marketing channels. Premarket Notification (510(k)), Exempt, Premarket Approval (PMA), De Novo Classification Request, Product Development Protocol (PDP), Humanitarian Use Exemption (HDE), and Biologics Licence Application (BLA) are some of the marketing paths.

Premarket Conditions – It could seem not easy to release a product on the US market. You may find it easier to manage the process if you follow these four steps.

To launch a device, follow these four steps:

Step 1: Arrange Your Device and Recognize the Controls That Apply

Determining your device’s FDA classification is the first step towards preparing it for US market release. The Federal Food, Drug, and Cosmetic Act’s section 201(h) defines a medical device legally.

Depending on their risk level, medical devices fall into one of three groups (I, II, or III). Class I devices are subject to the least regulatory control, and class III devices are subject to the strictest regulatory supervision. Regulatory controls rise as device class goes from class I to class II to class III.

The following table provides an overview of the various device classifications, regulatory restrictions, and submission types:

Class	Risk	Potential Harm	Regulatory Controls	Submission Type or Exemption
I	Lowest	Minimal harm	General	510(k) 510(k) Exempt
II	Moderate	Higher risk	General and Special (if available)	510(k) 510(k) Exempt
III	Highest	Highest Risk	General and PMA	PMA

Step 2: Choose the Appropriate Premarket Submission and Prepare It

Should your particular product’s classification call for a premarket submission, you should choose and get ready for it. The product categorization, available to the public through the Product categorization database, identifies the proper submission type for most medical equipment. Take note that not all gadget types call for a premarket submission. Visit the Class I/II Exemptions webpage for further details. You can move on to Step 4 and omit Steps Two and Three if your gadget doesn’t require a premarket submission.

Typical premarket submission formats include the following:

510(k) – A 510(k) is necessary for most class II and certain class I devices. The sponsor of a 510(k) must show that the new device is “substantially equivalent” to a predicate device about its intended purpose, technological features, and, if necessary, performance testing. See Device Advice Premarket Notification [510(k)] for details on how to fill out and submit a 510(k).

Certain class I and class II devices are not subject to the 510(k)-notification requirement provided they do not surpass the exemption limitations specified in 21 CFR xxx.9, where xxx is the 21 CFR 862–892 regulations. For instance, if an elastic bandage falls within the exemption limits outlined in 21CFR 880.9, it is not subject to premarket notification under 21CFR 880.5075.

PMA – Devices in PMA Class III need a PMA. The strictest kind of premarket submission is a PMA. The sponsor of a PMA must submit credible scientific data that demonstrates reasonable assurances of safety and effectiveness for the device’s intended use before the FDA can approve the PMA. See Device Advice Premarket Approval (PMA) for details on ready and submit a PMA.

Request for De Novo Classification – The De Novo procedure offers a way to categorize new medical devices for which there is no legally available predicate device, yet general controls alone, or general and special controls together, offer a reasonable assurance of safety and effectiveness for the planned purpose. Please consult the following sites for details on how to get ready for and submit a De Novo request:

HDE Humanitarian Use Device – HDE offers class III devices that help patients with uncommon diseases or conditions a regulatory pathway. A device sponsor must first apply to the FDA’s Office of Orphan Products Development (OOPD) for classification as a Humanitarian Use Device (HUD), which is required for the device to be eligible for an HDE. See Designating Humanitarian Use Device (HUD) for details on submitting a request for Humanitarian Use Designation.

Step 3: Get the necessary data ready for the premarket submission

After creating the submission of the premarket required for your device, you must submit it to the FDA and communicate with FDA personnel while the submission is being reviewed. Here are some things you should know before submitting your petition to the FDA:

Medical Device User Fees: Submitting some marketing applications is subject to a user fee. Program for Small Business Determination (SBD): Most user fees can be significantly reduced for a company that meets the requirements and receives certification as a “small business.”

eCopy Programme for Medical Device Submissions:
eSTAR: The eSTAR is an interactive PDF application that leads candidates through putting together a thorough submission for a medical device.

Step 4: Adhere to Relevant Regulatory Controls, Such as Device Listing and Establishment Registration

The FDA has the authority to oversee regulatory controls and risk-based standards that apply to medical devices and guarantee reasonable safety and efficacy.

Except in cases where regulations specifically exempt them, devices in all three classes (Class I, II, and III) are subject to general controls. These regulations, among other things, mandate that device facilities:

Register their businesses and list the medical devices they sell with the FDA;
Manufacture their products using current Good Manufacturing Practices;
Label their products in compliance with labeling regulations; and
Ensure that their products cannot be adulterated or misbranded.

Device facilities are required by law to register their business and list their devices with the FDA. Visit Device Registration and Listing for details on how to register and list. Device facilities must wait until a device has FDA clearance or approval before registering and listing if it needs to be submitted before it may be marketed (i.e., it is not exempt from this requirement for medical devices).

A medical device’s listing, registration, or assignment of a registration number does not, in any manner, imply FDA clearance or acceptance of the business or its goods.

Details to Take into Account for Premarket Submission Design Controls:

Under the Quality System Regulation, class II and class III devices must be designed in compliance with design controls (21 CFR 820.30). The majority of class I devices are exempt from design controls. Please refer to Design Control Guidance for Medical Device Manufacturers for further details on controls.
Nonclinical Testing: Several elements, such as the device’s classification, operating principles, technological features, and labeling, influence the data and testing required to sell your product. 21 CFR 58’s Good Laboratory Practices (GLPs) should be followed when conducting nonclinical testing to support a premarket application for a medical device.
FDA-Recognized Consensus Standards: The FDA promotes using these standards in premarket submissions. Using worldwide consensus standards is essential to a least-burdensome approach to device review. Compliance is optional unless a standard is referenced in a rule (see the Standards Medical Devices Federal Register Documents). The appropriate use of voluntary consensus standards in premarket submissions for medical devices is a guidance document that describes the documentation requirements for using standards in device submissions. This paperwork includes test results and declarations of conformance. If you have any inquiries about the proper application of consensus standards, email CDRHStandardsStaff@fda.hhs.gov.
Clinical Evidence: Clinical evidence is required for some 510(k)s, HDEs, PMAs, and De Novo Classification Requests. The research sponsor may need FDA clearance for an Investigational Device Exemption (IDE) before starting a clinical investigation. The relevant Institutional Review Board (IRB) must also approve the study. Clinical studies must abide by all applicable Good Clinical Practices (GCPs) and IDE laws. See Investigational Device Exemption (IDE) for further details on the GCP and IDE rules.
Labeling: You must include the device’s label in your premarket application and write it in compliance with labeling regulations.

To learn more about Device Labelling, please check out these links: Labelling Devices by 21 CFR 801 and the Unique Device Identification System (UDI)

The FDA designed the unique device identification (UDI) system to identify medical devices through their distribution and usage properly. Based mostly on device classification, the UDI rule became final in September 2013 and has been phased over several years. Improved patient safety and post-market surveillance are just two advantages the UDI System will bring to business, the FDA, consumers, healthcare professionals, and healthcare systems when fully operational. Please consult the following references for further details on UDI requirements:

Conclusion – Maintaining compliance with FDA regulations not only ensures market access but also demonstrates a commitment to patient safety and product efficacy. By following the outlined steps and guidelines, medical device manufacturers can navigate the regulatory landscape effectively, bringing innovative and safe products to market for the benefit of patients and healthcare providers alike.

How ND Global can help – At ND Global, we specialize in assisting medical device manufacturers with navigating the complex regulatory requirements set forth by the FDA. Our team of experts is well-versed in the intricacies of the regulatory process and can provide comprehensive support at every stage, from classification and premarket submissions to post-market compliance.

We offer tailored solutions to meet the specific needs of each client, ensuring that their products meet regulatory standards and achieve timely market entry. Our services include assistance with premarket submissions such as 510(k), PMA, and De Novo, as well as guidance on compliance with FDA regulations, including establishment registration, device listing, and labeling requirements.

With ND Global as your regulatory partner, you can streamline the regulatory process, mitigate risks, and expedite market approval for your medical devices. Let us help you bring your innovative products to market, ensuring patient safety and product efficacy every step of the way.