From Concept to Market:
FDA Approval Process for
Medical Devices

FDA Definition of Device

A “device” is defined by FDA as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or other similar or related article, including a component part of accessory:

• Recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them.

• Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in man or other animals.

• Intended to affect the structure or any function of the body of man or other animals and does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

 

To ascertain if your product qualifies as a medical device under FDA regulations, you should start by identifying its intended use (the function the device performs) and its indications for use (the specific condition or disease it is designed to diagnose, cure, mitigate, treat or prevent). Once these aspects are determined, you can evaluate whether your device aligns with the FDA’s definition.

Medical Device Classifications

The FDA classifies all medical devices into three broad categories based on their potential risk to patients and the level of regulatory control required for marketing. As the classification level increases, both the risk to the patient and the extent of regulatory oversight also rise.

1. Class I General Controls, with or without exemptions - Examples of Class I devices include elastic bandages, examination gloves and hand-held surgical instruments.

2. Class II General Controls and Special Controls, with or without exemptions - Examples of Class II devices include powered wheelchairs, infusion pumps and surgical drapes.

3. Class III General Controls and Premarket Approval - Examples of Class III devices include replacement heart valves, silicone gel-filled breast implants and implanted cerebellar stimulators.

How to determine the device classifications

To determine your device's classification and any applicable exemptions, you need to locate the regulation number that corresponds to its classification. There are two methods to achieve this:

1. Access the classification database and search using a keyword related to your device's name.

2. If you know the medical specialty (device panel) your device falls under, go directly to the listing for that device panel to identify your device and find the corresponding regulation.

Obtaining Market Access

The most common type of premarket submissions to obtain market access to FDA medical device include:

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

Premarket Notification (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.

A device is substantially equivalent if, in comparison to a predicate it:

• Has the same intended use as the predicate; and
• Has the same technological characteristics as the predicate; or
• Has the same intended use as the predicate; and
• Has different technological characteristics and does not raise different questions of safety and effectiveness; and
• The information submitted to FDA demonstrates that the device is as safe and effective as the legally marketed device.

Note: A claim of substantial equivalence does not mean the new and predicate devices need to be identical.

The types of 510(k) submissions

When seeking FDA clearance for your medical device under the premarket notification criteria, you have three different 510(k) pathways to choose from: Traditional, Abbreviated, and Special. Each pathway is tailored to different scenarios and requirements, as outlined in the FDA's "Refuse to Accept Policy for 510(k)s" guidance document. Understanding the specifics of each pathway is essential to selecting the most suitable option for your device.

Traditional 510(k)

The Traditional 510(k) pathway can be utilized for any original 510(k) submission or for modifications to a previously cleared device under 510(k) that does not meet the criteria for a Special 510(k) submission. It involves identifying a primary predicate device that closely matches your device in terms of indications for use, technological characteristics and substantial equivalence.

FDA generally reviews Traditional 510(k) submissions within 90 days of receipt.

Special 510(k)

Device manufacturers may choose to submit a Special 510(k) for changes to their own existing device if the method(s) to evaluate the change(s) is well-established and when the results can be sufficiently reviewed in a summary or risk analysis format.

FDA generally reviews Special 510(k) submissions within 30 days of receipt.

Abbreviated 510(k)

Device manufacturers may choose to submit an Abbreviated 510(k) when the submission relies on: FDA guidance document(s), demonstration of compliance with special control(s) for the device type, or voluntary consensus standard(s). Manufacturers submitting an Abbreviated 510(k) that relies on general use of a voluntary consensus standard should include the basis of such use along with the underlying information or data that supports how the standard was used.

FDA generally reviews Abbreviated 510(k) submissions within 90 days of receipt.

Premarket Approval (PMA)

Premarket approval (PMA) is the most stringent type of device marketing application required by FDA. The applicant must receive FDA approval of its PMA application prior to marketing the device. PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use.

Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. Due to the level of risk associated with Class III devices, FDA has determined that general and special controls alone are insufficient to assure the safety and effectiveness of Class III devices.

There are administrative elements of a PMA application, but valid scientific evidence to support reasonable assurance of safety and effectiveness of the device for the intended use is key to the approval of the PMA application. The PMA review process is multidisciplinary, collaborative and interactive, including scientific, regulatory and quality system review.

De Novo Classification

The De Novo request provides a marketing 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. De Novo classification is a risk-based classification process.

When and How to Prepare a De Novo Request

There are two options for submitting a De Novo request to the FDA for a risk-based evaluation to classify your device into Class I or II:

• Option 1: Submit after receiving a Not Substantially Equivalent (NSE) determination in response to a 510(k) submission. This determination may be due to a lack of an appropriate predicate, a new intended use, or different technological characteristics that raise new questions of safety and effectiveness.

• Option 2: Submit based on the requester's determination that no legally marketed device exists upon which to base a determination of substantial equivalence. This option does not require prior submission of a 510(k) or receiving an NSE determination.

Prior to submitting a De Novo request, the FDA recommends that sponsors consider submitting a Pre-Submission to obtain feedback from the appropriate premarket review division.

Humanitarian Device Exemption (HDE)

Bringing a Humanitarian Use Device (HUD) to market involves a two-step process. First, the applicant must obtain an HUD designation from the FDA's Office of Orphan Products Development (OOPD) and then, the applicant must submit an HDE application to the appropriate FDA premarket review center.

To be eligible to submit an HDE application, the applicant must have already received HUD designation and ensure that no comparable device is legally marketed for the same intended use (except for another approved HUD). When determining whether a comparable device exists, the FDA will consider:

• The device's indications for use and technological characteristics.

• The patient population intended to be treated or diagnosed with the device.

• Whether the device addresses the needs of the identified patient population.

How QT9 QMS can be used

QT9 Quality Management Software (QMS) can be an invaluable tool throughout the FDA approval process for medical devices. Here’s how QT9 can facilitate each stage from concept to market:

Design and Development:

• • Document Control: QT9 can manage all the necessary documentation ensuring compliance with FDA regulations. This includes design specifications, testing protocols and validation reports.

  • Design History File (DHF): QT9 can maintain a comprehensive DHF that includes all records from the design and development process, as required by FDA regulations.

Risk Management:

• • Risk Assessment: QT9 can help conduct and document risk assessments, ensuring all potential hazards are identified and mitigated.

  • Corrective and Preventive Actions (CAPA): QT9 can manage the CAPA process to address any identified risks or non-conformities, ensuring that they are resolved efficiently.

Regulatory Submission Preparation:

• • Document Management: QT9 can compile and manage all the necessary documents for 510(k), PMA, De Novo, or HDE submissions.

  • Compliance Management: QT9 ensures that all documents are up to date and comply with the latest FDA guidelines and standards.

Quality Assurance:

• • Audit Management: QT9 can schedule, conduct and document internal audits to ensure ongoing compliance with FDA regulations.

  • Training Management: QT9 can track and manage employee training records, ensuring that all personnel are adequately trained on FDA requirements and company procedures.

Post-Market Surveillance:

• • Complaint Handling: QT9 can manage customer complaints, ensuring they are investigated and resolved in a compliant manner.

  • Non-Conformance Management: QT9 can document and manage any non-conformances, ensuring that corrective actions are taken promptly.

 

By integrating QT9 into your FDA approval process, you can ensure that your medical device development and regulatory submissions are managed efficiently and in compliance with all FDA requirements.