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  1. Device Advice: Comprehensive Regulatory Assistance

How to Study and Market Your Device

How to Study and Market Your Device

Medical devices marketed in the United States are subject to the regulatory controls in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the regulations in Title 21- Code of Federal Regulations (21 CFR) Parts 1-58, 800-1299. The regulatory controls and marketing pathways are based on the risk of the device the regulatory controls needed to ensure reasonable assurance of safety and effectiveness. The marketing pathways include: Premarket Notification (510(k)), De Novo Classification Request, Exempt, Premarket Approval (PMA), Product Development Protocol (PDP), Humanitarian Use Exemption (HDE), and Biologics License Application (BLA).

Premarket Requirements

Bringing a device to the market in the United States may appear complex. Following these four steps may assist you to navigate the process.

Four steps to bring a device to the market:

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Step One: Classify Your Device and Understand Applicable Controls

The first step in preparing a device for marketing in the United States is to determine how the FDA has classified your device. A medical device is defined by law in the section 201(h) of the Federal Food, Drug and Cosmetic (FD&C) Act.

Medical devices are categorized into one of three classes (I, II, or III), based on the degree of risk they present. As device class increases from class I to class II to class III, the regulatory controls also increase, with class I devices subject to the least regulatory control, and class III devices subject to the most stringent regulatory control. The classes of devices, regulatory controls and submission types are summarized in the table:

Class Risk Potential Harm Regulatory Controls Submission Type or Exemption
I Lowest Present minimal potential for harm General 510(k)
510(k) Exempt
II Moderate Higher risk than class I devices General and Special (if available) 510(k)
510(k) Exempt
III Highest Sustain or support life, are implanted, or present potential unreasonable risk of illness or injury General and PMA PMA

For more information on regulatory controls (general and special controls) that may be applicable to your device, review the Regulatory Controls webpage.

The following resources may assist you in determining the classification of your device:

If your medical device is also a radiation-emitting electronic product, it should also comply with the applicable regulations in 21 CFR parts 1000-1050.

Notes:

  • If your product is a combination product - a medical device plus another FDA-regulated product (e.g. drug, biologics, etc.), you should contact FDA’s Office of Combination Product (OCP) by e-mail at: combination@fda.gov. Based on your product’s primary mode of action, OCP will tell you which FDA Center that you need to contact to market your product.
  • Even if your medical device does not require a premarket submission, you must still identify the correct classification for your device to understand and comply with the applicable regulatory controls.

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Step Two: Select and Prepare the Correct Premarket Submission

You should select and prepare the appropriate premarket submission, if one is required for your specific product’s classification. For most medical devices, the appropriate submission type is identified within the product classification, which may be obtained from the public Product Classification database. Note some device types do not require a premarket submission. For more information refer to the Class I/II Exemptions webpage. If you determine no premarket submission is required for your device, you may skip Steps Two and Three, and proceed to Step Four. The most common types of premarket submissions include:

  • 510(k) (Premarket Notification)
  • PMA (Premarket Approval)
  • De Novo Classification Request
  • HDE (Humanitarian Device Exemption)

510(k)

Some class I and most class II devices require a 510(k). In a 510(k), the sponsor must demonstrate that the new device is "substantially equivalent" to a predicate device in terms of intended use, technological characteristics, and performance testing, as needed. For information on how to prepare and submit a 510(k), see Device Advice Premarket Notification [510(k)].

Some class I and class II devices are exempt from the 510(k) notification requirement, if they do not exceed the limitations of exemption stated in 21 CFR xxx.9, where xxx refers to 21CFR 862-892. For example, an elastic bandage classified under 21CFR 880.5075 is exempt from premarket notification, provided that it does not exceed the exemption limitations stated in 21CFR 880.9.

PMA

Class III devices require a PMA. A PMA is the most stringent type of premarket submission. Before the FDA approves a PMA, the sponsor must provide valid scientific evidence demonstrating reasonable assurances of safety and effectiveness for the device’s intended use.

For information on how to prepare and submit a PMA, see Device Advice Premarket Approval (PMA).

De Novo Classification Request

The De Novo process provides a pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device. For information on how to prepare and submit a De Novo request, please refer to these resources:

HDE

HDE provides a regulatory pathway for class III devices that are intended to benefit patients with rare diseases or conditions. In order for a device to be eligible for an HDE, a sponsor must first obtain designation as a Humanitarian Use Device (HUD), which is granted through an application to FDA’s Office of Orphan Products Development (OOPD).

For information on how to request Humanitarian Use Designation, see Designating Humanitarian Use Device (HUD).

For information on how to prepare and submit an HDE application, please refer to these resources:

Additional Resources to Help Prepare a Premarket Submission

The FDA has developed several different types of resources to help you prepare a premarket submission. These include the following:

  • CDRH Learn: A video-based series of teaching modules, seminars, and recorded webinars that cover a variety of policy and guidance efforts.
  • CDRH's Q-Submission Program: Prospective applicants of future premarket submissions may request feedback from the FDA through a Pre-Submission, which is part of the Q-Submission Program. Information about this program may be found in the FDA guidance Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program. We encourage you to read our online information and other available resources prior to sending any request for feedback.
  • CDRH Breakthrough Devices Program: This voluntary program helps patients have more timely access to certain medical devices that treat or diagnose a life-threatening or irreversibly debilitating condition by speeding up their development, assessment, and review. Devices subject to Premarket Approval applications (PMAs), premarket notifications [510(k)] or De Novo classification requests may be eligible. Sponsors can send a Breakthrough Designation request for their device at any time prior to sending the device’s marketing submission.

Information to Consider When Preparing a Premarket Submission

Design Controls:
Class II and class III devices must be designed in accordance with Design Controls under the Quality System Regulation (21 CFR 820.30). Some class I devices are exempted from Design Controls. For additional information on Design Controls, please see: Design Control Guidance for Medical Device Manufacturers.

Nonclinical Testing: The types of information and testing required to market your device are determined by the device classification, mechanisms of operation, technological characteristics, and labeling. Nonclinical testing performed in support of a premarket submission for a medical device should comply with the Good Laboratory Practices (GLPs) in 21 CFR 58. For additional information please see Recommended Content and Format of Complete Test Reports for Non-Clinical Bench Performance Testing in Premarket Submissions.

The FDA encourages the use of FDA-recognized consensus standards in premarket submissions. Conformance is voluntary, unless a standard is incorporated by reference into regulation see the Standards (Medical Devices) Federal Register Documents. An integral part of a least-burdensome approach to device review is a reliance upon international consensus standards, therefore, the FDA issued a draft guidance entitled The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program : Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and FDA Staff. This voluntary, pilot program, is designed to increase consistency and predictability in the FDA's approach to assessing conformance with ASCA-eligible standards in medical device premarket reviews.

Clinical Evidence: PMAs, HDEs and some 510(k)s and De Novo Classification Requests require clinical evidence. Prior to initiating a clinical study, the study sponsor may need to obtain approval of an Investigational Device Exemption (IDE) by the FDA. The study will also need to be approved by the appropriate Institutional Review Board (IRB). Clinical studies must comply with all applicable IDE regulations and Good Clinical Practices (GCPs). For additional information on the IDE and GCP regulations, see Investigational Device Exemption (IDE).

Labeling: The labeling for a device must be written according to labeling regulations and included in your premarket submission.

For information on Device Labeling, please refer to these resources:

FDA has established a unique device identification (UDI) system to adequately identify medical devices through their distribution and use. The UDI rule became final in September 2013 and is being phased in over several years, based primarily on device classification. When fully implemented, the UDI System will offer a range of benefits to industry, FDA, consumers, health care providers and health care systems including improved patient safety and post market surveillance. For more information on UDI requirements please refer to the following references:

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Step Three: Prepare the Appropriate Information for the Premarket Submission

Once you have prepared the appropriate premarket submission for your device, you need to send your submission to the FDA and interact with FDA staff during its review. Before sending your submission to the FDA, you should be aware of the following:

  • Medical Device User Fees: There is a user fee associated with the submission of certain marketing applications. For information on which applications are subject to user fees, and the user fees for those applications, please see Medical Device User Fees.
  • Small Business Determination (SBD) Program: A business that is qualified and certified as a "small business" is eligible for a substantial reduction in most of these user fees. For more information on the SBD Program, please see Reduced Medical Device User Fees: Small Business Determination (SBD) Program.
  • eCopy: Premarket submissions must include an electronic copy (eCopy) on a compact disc (CD), digital video disc (DVD), or a flash drive. For detailed information on how to prepare your eCopy, please see eCopy Program for Medical Device Submissions.

Once your submission has been received by the FDA, you should be aware of the following:

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Step Four: Comply with Applicable Regulatory Controls, Including Establishment Registration and Device Listing

Regulatory controls are risk-based requirements that apply to medical devices and give FDA the oversight to ensure the reasonable safety and effectiveness of medical devices.

Devices in all three classes (Class I, II, and III) are subject to general controls, unless exempted by regulations, which require, in part, that device facilities: (1) register their establishments and list the medical devices they market with FDA; (2) manufacture their devices in accordance with Good Manufacturing Practices; (3) label their devices in accordance with labeling regulations; and (4) cannot be adulterated or misbranded. If a device is exempted from one of the general controls, such exemption is stated in the classification regulation for that device.

A device facility must register its establishment and list its devices with the FDA. Information about how to register and list may be found at Device Registration and Listing.

If a device requires a premarket submission prior to marketing (i.e., the medical device is not exempt), the device facilities must wait until it receives FDA clearance or approval before registering and listing.

Registration of a device establishment, assignment of a registration number, or listing of a medical device does not in any way denote clearance or approval of the establishment or its products by the FDA.

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