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Accessory or Component and the FDA – The Fine Line Between Them

Accessory or Component and the FDA – The Fine Line Between Them

Determining if your product or innovation should be considered a component or an accessory is a critical early-life cycle inflection point. In fact, the distinction between the two terms has long been the subject of debate and interpretation. In August 2017, the FDA began a new effort to classify a “list of [medical device] accessories that the Agency believes are suitable for distinct classification into class I.”  However, this effort lead to even more questions and less understanding between the classification designations and the actual device. Let’s try to break this down to help with the clarification process: What does the FDA consider an accessory versus a component?An accessory is intended to support, supplement, and/or augment the performance of one or more devices, often called “parent devices”. It is considered a finished device—meaning it is ready for use or capable of functioning.A component (in 21CFR 820.3) is defined as “…any raw material, substance, piece, part, software, firmware, labeling or assembly which is intended to be included as part of the finished, packaged and labeled device.” In other words, it would serve no direct medical purpose by itself, in the form that you deliver, and you are not selling directly to patients/end users/health care providers.21CFR 807.65(a) explicitly exempts “a manufacturer of raw materials or components to be used in the manufacture or assembly of a device…”  This means the parts or sub-components that go into make a device are exempt from Registration. The creator of the final device bears the burden of Registration. Let’s talk about some possible scenarios where this designation is important. Company A makes sensors that are incorporated into a finished blood...
10 Things You need to know about Human Factors Validation

10 Things You need to know about Human Factors Validation

As medical devices become more complex, the FDA will continue to place greater emphasis on ways to improve safety and effectiveness before products are commercialized. One relatively recent method is Human Factors Engineering, also known as Usability Engineering, which is used to identify and mitigate use errors. Of course, this can place additional burdens on manufacturers to justify that their device has accounted for as many of these potential risks as possible. The list below, which is by no means exhaustive, is intended to point you in the right direction as you prepare for meeting FDA requirements for Human Factors Validation Testing. Human Factors should be considered throughout the design and development process, not just when you’re ready to go to market. Formative evaluations, such as focus groups and expert interviews, can and should be conducted throughout the design and development process. These studies usually consist of 5-8 people and can be conducted somewhat informally. Valuable information can be gleaned from formative evaluations, such as design improvements and identification of potential use errors that could be mitigated by making adjustments to the device interface. Additionally, the FDA and other notified bodies often want to see how your design has been influenced based on the results of these studies. Summative evaluations are the formal validation studies conducted for the final version of the device. These studies are your Human Factors Validation Testing that must follow the requirements of the FDA guidance, Applying Human Factors and Usability Engineering to Medical Devices, and the EU standard, IEC 62366-1: Medical devices – Part 1: Application of usability engineering to medical devices. These studies...

How the 21st Century Cures Act Impacts Medical Device Software

There has been a lot of discussion surrounding medical device software and how it should be regulated. Concern about software of this nature will continue to rise to the forefront of conversations because there will be an increasing number of these products in the marketplace. The 21st Century Cures Act specifically addresses which types of medical device software will be exempt from regulation. Section 3060, Clarifying Medical Software Regulation, identifies five categories of medical software that will not be regulated as medical devices by the FDA due to their potential low level of risk to patients. The software categories that may be excluded from device regulation include: Administrative & Operational Software: that provides administrative support of a healthcare facility, such as that for appointment scheduling, health benefit eligibility and processing financial records. While this software is included in the provision, it was not considered a medical device to begin with. Wellness Apps: for maintaining or encouraging a healthy lifestyle that is unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition. This is consistent with FDA’s General Wellness and Mobile Medical Applications guidance documents. Electronic Patient Record Software: provided that it is only intended to transfer, store, convert formats or display the equivalent of a medical chart. There are some caveats to this exception, however: Records must be created, stored, transferred or reviewed by healthcare professionals; Records must be part of health information technology certified under section 3001(c)(5) of the Public Health Service Act; and The software must not be intended to interpret or analyze patient data or images for the diagnosis, cure, mitigation, prevention, or...
What Happens When the FDA says, “I don’t know”

What Happens When the FDA says, “I don’t know”

The FDA is now trying to track what it’s calling “emerging safety signals.” Recently, a study found a possible link between reduced leaflet mobility in TAVRs and the incidence of stroke in the fall. When people turned to the FDA looking for insight, the agency responded with, “Limited available data do not allow us to fully characterize the causes, incidence, and short- and long-term risks of reduced valve leaflet motion, or to recommend appropriate treatment.” This basically equates to the FDA saying, “I don’t know.” The FDA has recently released a guidance, which will formalize its practice on notifying the public of situations when the agency is monitoring risks that have not yet been fully validated, and therefore, do not have FDA recommendations. Historically, the FDA has communicated important medical device post-market information after having analyzed available data and, in most cases, after having reached decision about relevant recommendations and about whether or not further regulatory action is warranted. According to the guidance, timely communication about emerging signals is intended to provide health care providers, patients, and consumers access to the most current information concerning the benefits and risks of marketed medical devices so they can make informed treatment choices based on all available information. Such communication may also reduce or limit the number of patients exposed to the potential risk while the issue is being further evaluated. Considerations for Determining FDA Public Notification will include: Seriousness of the adverse event(s) relative to the known benefits of the device Magnitude of the risk (e.g., likelihood of occurrence) Magnitude of the benefit Strength of the evidence of a causal relationship...
FDA Oversight of Laboratory Developed Tests (LDTs) is on the Horizon

FDA Oversight of Laboratory Developed Tests (LDTs) is on the Horizon

How Do Laboratory Developed Tests Impact Your Business? The Office of Public Health Strategy and Analysis recently issued a report that reviewed 20 products that relied on Laboratory Developed Tests (LDTs) to determine whether a lack of oversight may have caused actual harm to patients or not. Once, LDTs were relatively simple tests that may not have warranted regulatory compliance. However, these tests are playing an increasingly more important role in healthcare and have become significantly more complex. The concern is that these tests may present with inaccuracies that place patients at what would be considered otherwise avoidable risk. The report found that these 20 products, in fact, may have caused actual harm to patients. In some cases, patients were told they have conditions they do not really have, due to false-positive tests. This led to unnecessary distress and resulted in unneeded treatment. In other cases, the LTDs produced false-negative results, in which life-threatening diseases went undetected. These misdiagnosed patients failed to receive treatments. Additionally, some LTDs provided information with no relevance to the condition they were intended to be used for, and others were linked to treatments based on disproven scientific concepts. Not only do these situations cause harm to patients, but they are also costly to society.(1) The report found that FDA oversight of LTDs is needed to address the following: Lack of evidence supporting the clinical validity of tests Deficient adverse event reporting No premarket review of performance data Unsupported manufacturer claims Inadequate product labeling Lack of transparency Uneven playing field Threats to the scientific integrity of clinical trials No comprehensive listing of all LTDs being used...