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In 2002, the Center for Devices and Radiological Health (CDRH) introduced the medical device user fee program. -
The Small Business Determination (SBD) program allows qualifying small businesses to pay reduced premarket review fees. -
Mandatory electronic registration for medical device companies.
2. Defining Combination Products
Besides defining medical devices, the FDA also defines combination products, which involve at least two of the regulated components drugs, devices and biologics. An example of a drug-device combination product is a drug-eluting coronary stent.
https://www.fda.gov/combination-products/jurisdictional-information/combination-product-contacts
3. Medical Device Regulations (21 CFR Parts 800–1050)
The specific regulations for medical devices are found in Parts 800 to 1050 of Title 21 of the Code of Federal Regulations (21 CFR):
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Parts 800 to 861 mainly set general regulations applicable to most device types. For example, Part 812 covers investigational device exemptions, a requirement that applies to all medical devices: -
Parts 862 to 1050 mainly cover requirements for specific devices. For example, Part 876 gives classification information and specific requirements for gastroenterology and urology devices. -
In addition, Parts 1 to 99 of Title 21 contain general regulations applicable to all medical products regulated by the FDA, including medical devices.
4. FDA Guidance Documents
The FDA sometimes issues final guidance documents reflecting its current thinking.
This link takes you to the FDA guidance document database, another important resource companies should use:
www.fda.gov/RegulatoryInformation/Guidances/defauit.htm
5. The FDA Classifies Medical Devices into Class I, II and III
Each device type is assigned a product code, a three-letter code that allows the FDA to group similar devices with the same intended use. Note that the same device with different intended uses may have a different classification, product code and class.
6. FDA Regulatory Controls: General Controls, Special Controls and Premarket Approval (PMA)
A device may be exempt from submitting to the FDA, or may require a 510(k) premarket notification or premarket approval (PMA); some alternative submission routes also exist.
7. FDA regulatory controls are:
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Requirements that apply to a product area (product code). -
Uniform general control requirements that, in a predictable way, promote the development of safe and effective medical devices with an appropriate regulatory burden or level of oversight. -
Regulatory controls are usually broad, but some may apply only to specific product areas.
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A basic general control is labeling. Part 801 of Title 21 of the Code of Federal Regulations sets out labeling requirements in detail. -
Another example is establishment registration. Under 21 CFR Part 807, companies must register with the FDA annually. -
Note that the last two items in the table – adulteration and misbranding – are set out in the Federal Food, Drug, and Cosmetic Act. -
Other controls are specified directly in the regulations.
8. Special Controls
Special controls are another type of regulatory control that applies only to Class II devices, usually for well-established device types, found in the “(b) Classification” paragraph of the regulation
Example: 21 CFR 876.5860(b).
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Special controls are not common. They are usually developed for mature device types: because these devices are well understood, consistent requirements can be defined to ensure safety and effectiveness. All devices regulated under the section must comply with any special controls established. -
The Code of Federal Regulations lists special control requirements for a device type in its classification subsection. Device-specific requirements are found in Parts 862 to 1050; if special controls are designated for a device type, they appear in subsection (b) of the device-specific regulation.
9. Four Steps to Bringing a Medical Device to Market Under FDA Requirements
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Define the product design and its use, which can be described in terms of intended use (usually broader) and indications for use (usually more specific). Also describe the duration of use and the target patient population, such as age range or the condition targeted. Confirm whether the product is a medical device. -
Determine the expected classification and regulatory pathway. Classification identifies the device’s class and usually also tells the company what regulatory submissions are needed to market the device. -
Generate the information needed to support the device’s safety and effectiveness, known as valid scientific evidence, defined in 21 CFR 860.7(c)(1) and (2). Evidence supporting approval may include preclinical, animal and clinical studies. -
The final step is to prepare and submit the premarket submission. Each submission type has its own process, requirements, review time and burden of proof. By following these 4 steps, companies can clear the way for market launch.
10. The Five Common Types of Marketing Submissions
The five most common submission types are: Investigational Device Exemption (IDE), Premarket Notification (510(k)), Premarket Approval (PMA), De Novo requests and Humanitarian Device Exemption (HDE)
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The Investigational Device Exemption (IDE) is the only submission not made to bring a product to market. Instead, it is submitted to obtain FDA approval to conduct a clinical study with your investigational device. In an IDE, companies collect clinical evidence of safety and effectiveness as part of the overall valid scientific evidence to be included in a future marketing submission. Clinical studies usually require approval from both the FDA and an Institutional Review Board. -
The 510(k) is the most common premarket submission, mainly for low-to-moderate risk Class I and II devices. It is a comparative submission in which the FDA determines whether the new device is substantially equivalent to a legally marketed Class I or II predicate. In this comparison, the FDA reviews three core aspects: intended use, device characteristics, and, where necessary, performance test results. -
Another submission type is Premarket Approval (PMA), the marketing application for high-risk Class III devices and devices without an existing classification. Unlike a 510(k), the PMA evidence must stand on its own rather than being an equivalence assessment against another legally marketed device. -
The De Novo submission applies to devices without an existing classification regulation. De Novo requests are therefore usually for devices regulators have not previously evaluated – mostly new, novel device types. The De Novo process helps new products reach the market by creating a new Class I or II classification regulation for the device type. It can be seen as an alternative to PMA, with the advantage of a lower regulatory burden for novel device types. -
The HDE is the premarket submission for humanitarian use devices intended to treat or diagnose patients with a disease or condition affecting small populations. Unlike a PMA, an HDE device does not need to demonstrate effectiveness; instead, the HDE must demonstrate reasonable assurance of safety and probable benefit.