Trial Magazine

With the 2018 release of the Medical Device Safety Action Plan, the FDA seeks to modernize the premarket and ­postmarket approval process for medical devices—including the outdated 510(k) approval model for medical devices—with the goal of improving safety.¹ Under current law, a manufacturer may avoid the premarket approval application process by showing that its device is “substantially equivalent” to a currently approved device.² This process, however, allows manufacturers to use extremely old predicate models that do not operate with current technologies and do not reflect modern safety and security innovations.

In January, the FDA released guidance requesting comments on whether manufacturers should be required to post medical device approvals online when basing substantial equivalence on predicate models that are more than 10 years old. The agency hopes this increased transparency will encourage manufacturers to use newer predicate models with the latest safety and security improvements.

Unique identifiers. After a medical device is approved, the FDA will issue a unique identifier to each device for easy tracking, which will help identify defective devices and quicken the response time for safety recommendations. Currently, it can be difficult to locate exact medical devices within a category. For example, the FDA may find that an insulin tube is defective but cannot detect the exact model that contains the defect. Unique identifiers will help remedy this issue.

Cybersecurity risks. The FDA also plans to address device cybersecurity risks. FDA guidance will create two categories: tier 1 devices that are hackable, and tier 2 devices, which include everything else.

Tier 1 devices—such as pacemakers and brain stimulators—can remotely connect to any other medical device, creating cybersecurity risks that could harm patients. Tier 1 device manufacturers will be encouraged to disseminate a cybersecurity guide that details software and hardware components that are or could become susceptible to vulnerabilities to patients who use these devices.

Finalizing these rules and guidances will continue throughout 2019 and 2020. For more information, please email Brian McMillan, AAJ’s federal relations counsel, at brian.mcmillan@justice.org, or email advocacy@justice.org.

1. Fed. Drug Admin., Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health (2018), https://tinyurl.com/y7zoghon.
2. 21 C.F.R. §807.92(a) (2018).