- Hi there, my name is Katherine Kim, and I'm the acting senior advisor for medical devices, here at FDA with the Center for Biologics Evaluation and Research, in the Office of Regulatory Operations. I'm pleased to present to you information about the medical devices, and combination products reviewed here at CBER. FDA regulates a wide range of diverse products as medical devices.
Medical devices may be as simple as a tongue depressor, and as complex as an artificial heart. Because of the wide range of medical devices, it is important to gain a better understanding of how FDA defines medical devices. According to section 201 H of the Federal Food, Drg and Cosmetics Act, or what is also referred to as the FDNC Act, a medical device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component or accessory which is recognized in the official National Formulary, or the US Pharmacopeia, or any supplement to them, or is 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, or it is intended to affect the structure, or any function of the body of man or other animal, in which is not achieved 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.
FDA classifies devices, or more accurate accurately, device types, in order to identify the degree of regulation for that product area. FDA classifies devices into class one, two, or three. The class of a device generally increases with its degree of risk.
As the risk of the device increases, so does the regulatory control to ensure its safety and effectiveness. For example, class one devices generally present the lowest level of risk, as they are subject to general controls only. Here at CBER, examples in this category include blood banking supplies, such as pipettes and blood typing tubes.
Class two devices, as you can imagine, prevents higher risks than class one devices, and require general and special controls. Examples of class two devices include automated blood grouping and antibody test systems. Lastly, class three are your highest risk level set of devices, specifically to sustain or support life, are implanted, or present potential unreasonable risk of injury or illness.
Class three devices are subject to the most stringent regulatory control here at FDA. Examples of class three devices include HIV self-testing diagnostic tests, and autologous cell harvesting devices. This slide illustrates the medical device development pathway, also known as a total product lifecycle.
It starts with a discovery, goes through prototyping, conduct preclinical or bench testing, may include clinical trial testing, then submit the appropriate information to FDA, wait on a regulatory decision if applicable, prior to product launch in the US market, and post-market monitoring. In terms of the regulatory steps for medical device development, the first step is to determine the device classification, because device regulations are risk-based. The device classification will generally provide guidelines towards the correct pre-market submission.
After determining the proper pre-market submission type, the next step is to prepare and submit the appropriate information to FDA. There are different interactions with FDA, a submitter may submit a Q-submission to obtain FDA feedback at any time along the medical device development pathway. Prior to starting a significant risk clinical study, a sponsor must submit what's known as an investigational device exemption, also known as IDE, for FDA approval.
Dependent on the device classification, pre-market submission may be required prior to marketing a device. Different pre-market submission types include a pre-market notification submission, also known as a 510(k), a De Novo request, a pre-market approval application, also known as PMA, and a humanitarian device exemption, also known as an HDE. This slide provides a brief overview of what we discussed earlier about how device regulations are risk-based.
The submission type is based on the device classification, and whether or not there are general, and or special controls in place. For additional information on the different submission types, please refer to the CDRH learning videos listed to your right. A combination product is a product comprised of two or more regulated components.
This may include a drug or device, a biologic and a device, a drug with a biologic, or a drug device and a biologic all in one, and there are generally one out of four scenarios. These can either be physically, chemically, or otherwise combined, or mixed, and produced as a single entity. Two or more separate products packaged together in a single package, or as a co-packaged unit.
Packaged separately and cross labeled for use only with an already approved product, or packaged separately and cross labeled with another investigational product. Examples of combination products that we commonly see here at CBER include pre-filled syringes, and intranasal delivery devices. There are a lot of components involved in the review of the device constituent component of a combination product.
Depending on the product type, this may include the following, the device description, sterilization procedures, packaging information, the shelf life, or the expiration of your device, biocompatibility, software, electrical safety, electromagnetic compatibility, the device performance in itself, labeling, human factors, its regulatory status, clinical protocol, if any, and quality systems and manufacturing the product. FDA reviewers need adequate information of these items to assess the safety and effectiveness profile of the device. Human factors testing is a valuable component of product development for medical devices and combination products.
Understanding how people interact with technology, and studying how user interface design affects the interactions people have with technology is the focus of human factors engineering, and usability engineering. Human factors engineering, and usability engineering considerations in the development of medical devices involve the three major components of the device user system. Number one, the device users.
Number two, the device use environments. And number three, the device user interfaces. The interactions among the three components, and the possible results are depicted graphically in the figure to the right.
The goal is to ensure that the device user interface has been designed such that user errors that occur during use of the device that could cause harm, or degrade medical treatment, are either eliminated, or reduced to the extent possible. For further information, please refer to the guidance document link below. Thank you for listening, this concludes part six of seven of this lecture.
