More Regulation is Better for Certain Medical Devices: Industry Tells FDA
(Thursday, March 25, 2021)
In an atypical move, many medical device companies are petitioning FDA to continue the 510k requirements for several Class II devices after FDA proposed that those devices are safe enough to not need such regulation and should be downgraded to 510k-exempt status. And in the process, the commenters exposed many holes in the current regulatory processes that raise new questions. Every few years, FDA reviews existing Class II medical devices to evaluate if the 510k process is still adequate for them and exempts devices with significant safe usage history. Such announcements are mostly uneventful and well-received by industry and public alike as it increases the access to such devices by reducing the regulatory burden to market them to consumers. However, that changed this year. On January 15 of this year, the last week of the Trump administration, FDA announced that it will take 83 devices off the 510k-required list. This list included diverse medical devices such as almost all kinds of gloves, thermal cameras, digital stethoscopes, most masks, gowns, sterilizers, and many digital health products. Most people did not object to the 510k exemption for these devices except for the digital health products. Of the 56 comments posted to the regulation so far, most are by digital health groups and companies that complained that FDA’s criteria for lifting the 510k requirement for their products was too lax and would hurt such products overall. Almost everyone opposing the FDA proposal pointed out to the inadequate nature of the medical device adverse event reports submitted voluntarily to the FDA, which was the primary criteria for FDA’s proposal. Many also pointed to the relatively nascent nature of the digital health industry where most products are based on less understood technologies and have been in the market only a few years. Many tacitly acknowledged that getting FDA’s stamp of approval is critical for the public acceptance of their products and indicated that the cost for 510k review was not much, and that delays in the market access due to the 510k requirements were an accepted risk. It may be surprising to the lay people why the industry, that always complains of over-regulation, is pleading the opposite in this case, but it seems the companies are trying to protect their interests. Developing and getting a device through the 510k process costs an average of $4 million which is a barrier to many and keeps the field limited to serious, well-funded developers. No one mentioned that the same devices will not require regulatory approval anywhere else in the world and that many of these same devices are available safely in other countries. It should be noted that the timing of this FDA announcement made it politically easier to oppose it. Are the companies genuinely concerned about the safety of their devices or is there a politico-economic reason for such opposition to reduced regulation? The answer is not that simple.

---

AUTHOR               

 Dr. Mukesh Kumar
​ Founder & CEO, FDAMap

 Email: [email protected]
​ Linkedin: Mukesh Kumar, PhD, RAC
 Instagram: mukeshkumarrac 
                           Twitter: @FDA_MAP
                           Youtube: MukeshKumarFDAMap

​

---