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510(K) FDA Clearance Debate


The considerations of safety provide the most critical orientation for present-day medical facilities. However, the efficiency of their work is compromised by the policies of the government regarding the procedure of the acceptance of new devices for mass production and distribution. Since it is solely based on the principle of their resemblance to previous inventions without additional assessments, they can be viewed as objects potentially hazardous to one’s health [1]. This concern leads to the attempts of scholars to analyze the statistics of such goods’ usefulness reported by clinics and hospitals [2]. Hence, the practice of 510(K) clearance initiated by the U.S. Food and Drug Administration (FDA) is a dubious method, which poses a threat to the population’s safety.

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The data relating to orthopedic devices proves the dangerous nature of this approach. They include the evidence on the prevalence of medical devices that underwent the Premarket Notification 510(K) process over the ones subject to Premarket Approval (PMA) review [1]. The latter incorporates various clinical trials and, therefore, is more complicated and time-consuming than the former’s pathway [1]. As a result, the number of occasions of recalling devices after their exploitation was allowed by 510(K) clearance is much greater [1]. This outcome implies the non-inclusion of such factors like efficiency and safety in the matter. Therefore, healthcare providers should pay attention to the method of these devices’ approval by the FDA and give preference to the ones confirmed by the PMA review.

The same conclusion was drawn from the analysis of otolaryngologic and dermatological devices, which adds to the credibility of this stance. The results of the former’s study demonstrated the absence of clinical evidence related to the influence of moderate-risk devices on patients [2]. The latter’s outcome, in turn, highlighted the importance of the problem in the context of increasing production of dermatological tools and, therefore, their dominant clearance through the 510(K) procedure established by the FDA [3]. The experience of the medical personnel with such devices proved that this procedure leads to the emergence of health issues due to the neglect of specific aspects of devices’ design [3]. In this way, the seeming responsibility of doctors is extended to the use of improper devices, even though it is only indirectly related to their principal duties.

Another factor contributing to the inappropriateness of 510(K) clearance supported by the government is non-compliance with this practice with legislative initiatives and regulations. Thus, for example, a product, which was considered legally permissible and, therefore, accepted for manufacturing in the previous century, might contradict recently emerged rules [4]. This situation occurred with mid-urethral slings, which were prohibited by the National Health Service but were still produced by some companies based on the 510(K) procedure [4]. Therefore, this method can be used by other enterprises and present a threat to patients’ health. What is more important, in this case, is that it is unlikely that the responsibility for illegal actions of this nature would ever be established.


To summarize, the practice of 510(K) clearance promoted by the government should not be viewed as a legal method of approving new technological solutions. The issue of its spread throughout the country is conditional upon the lack of clinical trials and results in the creation of unacceptable conditions for rendering medical services by healthcare facilities. Moreover, this procedure contradicts possible legal considerations since it does not address them. Thus, it can be concluded that the optimal way to establish the quality of assistance provided by specialists is to only use the devices which underwent the PMA process.


C. S. Day, D. J. Park, F. S. Rozenshteyn, N. Owusu-Sarpong, and A. Gonzalez, “Analysis of FDA-approved orthopaedic devices and their recalls,” The Journal of Bone & Joint Surgery, vol. 98, 2016. Web.

V. K. Rathi, S. K. Gadkaree, J. S. Ross, E. D. Kozin, R. K. Sethi, M. R. Naunheim, S. V. Puram, and S. T. Gray, “US Food and Drug Administration clearance of moderate-risk otolaryngologic devices via the 510(k) process, 1997-2016,” Otolaryngology-Head and Neck Surgery, vol. 157, Web.

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H. H. Ezaldein, S. T. Hill, M. Merati, A. Suggs, B. Reichert, and J. F. Scott, “Dermatologic device clearance within the Food and Drug Administration’s 510 (k) pathway,” Lasers in Surgery and Medicine, Web.

H. P. Dietz, “The Tissue Fixation System: How obsolete and potentially dangerous technology continues to be ‘sold’,” Australian and New Zealand Journal of Obstetrics and Gynaecology, vol. 59, Web.

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