The Food and Drug Administration (FDA) has published an information sheet guidance describing the regulatory aspects related to the Significant Risk and Nonsignificant Risk medical device studies. The document is intended to provide additional clarifications and recommendations to be considered by the parties, interested in placing their medical devices on the US market (sponsors), clinical investigators, and also the representatives of the regulating authorities engaged in the process. Show Due to its legal nature, the guidance does neither introduce any rules nor impose any obligations for the parties involved. The Agency explicitly states that the alternative approach could be applied, providing that such an approach complies with the applicable regulatory requirements and has been agreed with the Agency in advance. It is also important to mention that the information sheet guidance document has been initially issued in January 2006, and has not been subject to any additional reviews or amendments, except the revision conducted to update the examples contained therein and clarify the responsibilities of the regulating authorities, as well as to align it with other FDA regulations. Regulatory Background
As it was already mentioned before, the present FDA guidance contains additional clarifications to be considered by the medical device manufacturers, their authorized representatives, clinical investigators, and also institutional review boards (IRBs) when conducting a risk-based determination of clinical studies. In particular, the document describes the regulatory aspects related to significant risk and nonsignificant risk medical device studies. In accordance with the Investigational Device Exemptions (IDE) regulation (21CFR 812), all medical device studies coulee divided into three types:
The present document addresses the first two types, while the details about the third one are provided in a separate guidance document issued by the FDA. Study Type DeterminationThe Agency describes the criteria to be applied when determining the risk type of a medical device study subject to review. According to the document, in case of significant risk studies, the following criteria are applicable:
The FDA states that all medical device studies that do not meet the criteria listed here should be classified as nonsignificant risk studies. Under the general rule, a party interested in placing a medical device on the market (a sponsor) conducts the initial risk determination and communicates the decision taken to the institutional review board. At the same time, the parties engaged may also ask the Agency to assist in risk determination. In case there is no final determination made by the FDA, the institutional review board should determine the risk type of each medical device clinical study. In case of any discrepancies, the determination made by the FDA should prevail and thus be deemed final. Medical Device Study Types in DetailAccording to the present FDA guidance, the main differences between significant risk studies and nonsignificant risk studies are in the following aspects:
Further, the FDA guidance states that in case of significant risk medical device studies, a sponsor shall comply with the regulatory requirements set forth under the IDE regulations at 21 CFR 812 and also to have the IDE application approved by the regulating authority in advance. According to the document, the nonsignificant risk medical device studies should comply with the abbreviated requirements set forth by 21 CFR 812.2(b) in terms of labeling, IRB approval, informed consent, monitoring, records, report, and the prohibition against promotions. At the same time, a sponsor of the NSR medical device study is not obliged to make reports to the regulating authority. The requirement to have an IDE application approved by the Agency could be also waived. Moreover, in the case of a nonsignificant risk medical device study, there is no obligation to inform the FDA about the IRB approval. In other words, an NSR medical device study could be commenced once approved by the IRB without the need to inform the Agency since the approval of the latter is not required. Responsibilities of the PartiesIn order to assist all the parties involved in complying with the applicable regulations, the present FDA guidance also outlines the scope of responsibilities of each party. For instance, depending on the type of the medical device study, the responsibilities of the study sponsor would include:
The document also describes the corresponding responsibilities of the IRB. According to the document, an institutional review board shall:
Summarizing the information provided here above, the present FDA guidance describes the way the type of the medical device study should be determined depending on the risks associated thereto. The document also outlines the responsibilities of all the parties involved and describes the appropriate procedures. How Can RegDesk Help?RegDesk is a next-generation web-based software for medical device and IVD companies. Our cutting-edge platform uses machine learning to provide regulatory intelligence, application preparation, submission, and approvals management globally. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Applications that normally take 6 months to prepare can now be prepared within 6 days using RegDesk Dash(TM). Global expansion has never been this simple. Sources: https://www.fda.gov/media/75459/download Want to know more about our solutions? Speak to a RegDesk Expert today! What is a significant risk device?Significant Risk Device
Significant risk devices may include implants, devices that support or sustain human life, and devices that are substantially important in diagnosing, curing, mitigating or treating disease or in preventing impairment to human health.
What are the criteria for significant risk?Significant risk (SR) device
Is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject; or.
Which identifies a high risk device?Class III medical devices are those devices that have a high risk to the patient and/or user. These devices usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury. They represent 10% of medical devices regulated by the FDA.
What is a significant risk study?An SR device study is defined [21 CFR 812.3(m)] as a study of a device that presents a potential for serious risk to the health, safety, or welfare of a subject and (1) is intended as an implant; or (2) is used in supporting or sustaining human life; or (3) is of substantial importance in diagnosing, curing, mitigating ...
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