white paper

FDA Regulatory Pathways for Medical Devices

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Regulatory Compliance Associates® Inc. (RCA) provides worldwide services to the pharmaceutical, biologic, sterile compounding, biotechnology, and medical device industries for resolution of compliance and regulatory challenges.

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FDA Regulatory Pathways for Medical Devices


There has been a recent explosion of innovative medical device products launched in the US and global markets. The medical device industry is now capable of using 3D printers to produce everything from prosthetic parts to artificial knees to surgical tools. In addition, the regulatory pathway of mobile health (mHealth) applications for smart phones has seen an upsurge in interest.

Medical innovators are continually focusing on new products that deliver better, faster, and less costly patient care. Advancements being developed in the medical device field include:

  • The use of 3D printers for surgical tools and medical equipment
  • mHealth applications for monitoring patient vital signs
  • Electronic aspirin using a handheld remote controller, needle free diabetes care using patch technology
  • The development of a transcatheter aortic valve for insertion in patients not suitable for open-heart surgery
  • Brain-machine interfaces for amputees and potentially for spinal cord injury treatment.



Software as a medical device (SaMD) is used for collecting healthcare data and delivering patient information to doctors. This helps physicians monitoring patient vital signs in real-time. Medical device users, consumers, and patients expect medical device manufacturers to consistently develop and launch contemporary, state-of-the-art products and technologies. The goal is to achieve greater benefits for the patient that ultimately result in more effective care and outcomes.



To ensure these products are safe and effective, the FDA and other global Regulatory Authorities place a heavy burden on the medical device industry to demonstrate that such products are designed, developed, tested, and manufactured according to Current Good Manufacturing Practices (cGMPs) and other applicable Standards and Guidance. Obtaining regulatory clearance or regulatory pathway approval for new medical device products and technologies has historically been a complex and challenging process for many manufacturers.



However, in recent years the FDA has taken a more proactive approach to collaborate with industry and streamline the evaluation process of these innovative medical devices to bring safe, effective, and novel products to market faster for the ultimate goal of advancing of public health. Regulatory Compliance Associates® has developed this white paper to help our clients understand the current regulatory pathways for medical devices intended for registration in the US. This paper will highlight advancements being made and the FDA’s goal of ensuring the safety and effectiveness of medical devices and novel technologies.


Regulatory Strategy

The first step in determining the most appropriate regulatory pathway to obtain clearance or approval of a new or modified medical device in the US market is to develop a robust regulatory strategy that aligns the business objectives and the regulatory requirements necessary for market launch of the product.


Intended Use

It is critical to accurately describe the device in terms of its intended use, indications for use, target population of users and / or patients, functional and / or performance characteristics, labeling and desired marketing claims for the device. These factors, when coupled with the determination of the device classification, applicable product code(s) for the device, and whether a predicate device(s) exists, will serve as the foundation to determine the most appropriate submission type and regulatory pathway.


FDA Approval

Inventors face a smoother clearance (or regulatory pathway) if they are informed and prepared with a regulatory strategy prior to engaging with the FDA. Understanding the various device classifications and controls, as well as, the various regulatory pathways to obtain clearance or approval establishes the foundation for a cooperative partnership and with the USFDA and helps ensure expeditious clearance or approval of your medical device product.


Device Classifications 

medical device consultantsUnderstanding the different USFDA device classifications and the level of control applied to them helps the applicant determine the correct clearance or approval pathway. The FDA has established approximately 1,700 different generic types of devices that are grouped into 16 medical specialties. The product code and device classification of the medical device is designated under 21 CFR Parts 862-892.

The FDA has established approximately 1,700 different generic types of devices that are grouped into 16 medical specialties.


Risk Classification

Determining which category a medical device falls into is defined by indications for use, the intended use, and the risk of the device, which drives the level of control a manufacturer must put in place at their facility and throughout their distribution chain to ensure that the device is safe and effective for its intended use. Lower risk medical devices have the least regulatory control applied to them whereas higher risk medical devices have the most stringent regulatory control applied to them because they may be life supporting and / or life sustaining devices.


Regulatory Pathway

The appropriate regulatory pathway to obtain US market clearance or approval for your product is determined primarily by the intended use, indications for use, risk and the classification of the device. The most common pathways to market for devices in the US include:

  • Premarket Notification [i.e., 510(k)]

Required for some Class I devices and most Class II devices. There are three types of 510(k) submissions including:

  • Traditional 510(k): The Traditional 510(k) may be used when a new device is substantially equivalent to a predicate device already cleared for marketing in the US, or for a modification to a previously cleared 510(k) device.
  • Special 510(k): The Special 510(k) is used for device modifications to a previously cleared 510(k) device that do not affect the intended use of the device or alter the fundamental scientific technology of the device and utilizes the design controls aspect of the Quality System (QS) regulation (21 CFR 820.30).
  • Abbreviated 510(k): The Abbreviated 510(k) may be used when a guidance document exists, special controls for the device have been established, or when the FDA has recognized relevant consensus standards. Summary reports on the use of guidance documents and / or special controls or declarations of conformity to FDA recognized standards must be included with the submission.


Premarket Notification

Companies intending to market a Class I, II and select III devices must submit a Premarket Notification or 510(k) to FDA. This submission must be at least 90 days before marketing the device. Many Class I and II devices may be exempt from 510(k) regulations. Therefore, confirmation must be at the beginning of the submission confirm whether or not the device is exempt in the USA.


Premarket Approval (PMA)

Required for Class III devices. The FDA’s typical review cycle for a Premarket Authorization (PMA) is 180 days. There are several types of PMAs and PMA Supplements including:

  • Traditional PMA: An original PMA application is an extremely comprehensive submission. Each PMA includes a considerable amount of objective evidence to support the safety and effectiveness of the device. This includes the device description, indications for use and intended use. Nonclinical and clinical studies, case report forms, manufacturing methods, and labeling are also required.
  • Modular PMA: A Modular PMA is often an appropriate route for products in the early stages of a clinical study. The contents of a Modular PMA are submitted to the FDA in separate modules (i.e. preclinical, clinical, manufacturing). Each submission occurs upon the applicant’s completion of each separate module. All modules collectively constitute the entire Modular PMA.
  • Product Development Protocol: The Product Development Protocol route is typically used for well established products in industry. It requires an agreement between the Sponsor and the FDA as to the evidence required to demonstrate safety and effectiveness. Once agreement with the FDA is reached with the Sponsor regarding the design and development activities, the Sponsor must comply with reporting milestones. Particularly, this involves submitting the supporting documentation and milestone reports to the FDA for review. Once the FDA declares the Product Development Protocol completed, it is considered an approved PMA.


Innovative Regulatory Pathways

De Novo Application

The De Novo pathway is most appropriate for novel, low to moderate risk devices. The risk is presumptively designated due to no identifiable predicate device for a equivalence comparison. The de novo process provides a pathway to classify a low to moderate risk device for which controls or general. Further, special controls can provide reasonable assurance of safety and effectiveness but for which there is no predicate device. The FDA’s typical review cycle for a De Novo Application is 120 days.

HUD is intended to benefit patients by treating or diagnosing a disease or condition that affects fewer than 4,000 individuals.


Humanitarian Use Device (HUD)

A Humanitarian Use Device (HUD) is a unique device with no other comparable devices available, that is intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year.


Humanitarian Device Exemption (HDE)

To obtain approval for an HUD, a humanitarian device exemption (HDE) application is submitted to FDA. The HDE must contain sufficient information to demonstrate that the device does not pose an unreasonable or significant risk of illness or injury. FDA consultants look to emphasize how the probable benefit to health outweighs the risk of injury or illness. Moreover, this takes into account the risks of currently available devices or alternative forms of treatment.


An HDE application is similar in both form and content to a premarket approval (PMA) application. However, it is exempt from the effectiveness requirements of a PMA. The applicant is not required to include the results of scientifically valid clinical investigations. The FDA’s typical review cycle for a Humanitarian Device Exemption Application is 75 days.


Regulatory Plan

Predicated upon the regulatory strategy, the second step is to define a device-specific regulatory plan. This regulatory plan includes a comprehensive list of all of the submission deliverables needed flor review. Generally, the applicable FDA guidance documents, and / or testing standards are the most important for consideration.


Regulatory Submission

FDA guidance documents provide invaluable information about the required documentation included in a regulatory submission. This includes the performance, bench, animal testing and clinical data required for device classification.


FDA Guidance

Considering the applicable FDA guidance for your specific medical device is addressed early in the development process. For example, the FDA expects manufacturers to follow human factors or usability engineering processes during the development of new medical devices. This helps ensure that devices are safe and effective for the intended users and use environments. Comparatively, the user interface is designed so errors which occur during use of the device that degrade treatment are reduced.


Human Factors

The FDA expects that for certain types of medical devices with the potential for serious harm resulting from user error, human factors data must be included in the premarket submissions for the FDA to evaluate the safety and effectiveness and substantial equivalence of these devices. 

Manufacturers also may not be fully aware of the costs and long-lead time required to complete product testing. Above all, obtaining clinical data necessary for regulatory submission must consider the time required for the FDA’s review cycle of the device. The regulatory strategic plan must include a projected timeline, costs and resources associated with obtaining the testing / clinical data.


Regulatory Strategy

Navigating through the various regulatory pathways to obtain market clearance or approval for your device can be a challenging and overwhelming process. Let RCA assist your team in determining the correct regulatory strategy for medical device. RCA has extensive subject matter expertise in developing regulatory strategies, plans and product submissions. Additionally, we’ve assisted countless manufacturers gain market approval for their products.


About RCA

regulatoryRegulatory Compliance Associates® (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:


We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies.

As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.



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