March 20, 2019

March 19, 2019

Subscribe to Latest Legal News and Analysis

March 18, 2019

Subscribe to Latest Legal News and Analysis

Medical Device FDA Approval Process Changes

On November 26, 2018, the U.S. Food and Drug Administration (“FDA”) announced the process for clearing most medical devices for marketing is being updated to incorporate changes the FDA laid out in an April draft guidance. For over forty years, most medical devices have entered the United States market through the 510(k) clearance process. The 510(k) process offers an expedited approval process available only for products that are substantially equivalent to products already on the market (known as predicate devices). The FDA is considering no longer allowing sponsors to rely on predicates older than ten years and making public information about cleared devices that relied on predicates more than ten years old. In addition, the FDA intends to finalize guidance establishing an alternative 510(k) pathway with different criteria that reflect current technological principles.

In a statement, FDA Commissioner Scott Gottlieb reasoned that newer products relying upon older predicates might not reflect new performance standards or latest scientific and medical understanding. Commissioner Gottlieb believes this change will promote the continual improvement of medical devices. However, the announced change received quick pushback. Many manufacturers argue that reliance upon older predicates can be necessary when no newer predicates are available, and older predicates can provide data that helps sponsors make new devices safer. In addition, many industry-observers believe the FDA’s plans may contradict and exceed its statutory authority, and therefore require additional support from Congress.

If the current proposal becomes law, the implications will include increased costs for manufacturers forced to innovate because of the inability to rely on older predicates. The agency’s statement indicates that new medical devices that utilize the 510(k) pathway should be better than predicates, rather than the applicable legal standard of substantial equivalence. Thus, manufacturers can anticipate increased agency scrutiny when submitting information in the 510(k) summaries. In addition, manufacturers may need to make alternative plans if developing a new device based on an older predicate.

©2019 Epstein Becker & Green, P.C. All rights reserved.

TRENDING LEGAL ANALYSIS


About this Author

Audrey Davis food and drug law Epstein Becker Washington DC
Law Clerk

Audrey Davis* is a Law Clerk – Admission Pending – in the Health Care and Life Sciences practice, in the Washington, DC, office of Epstein Becker Green. She will be focusing her practice on food and drug law, fraud and abuse, health care compliance, and managed care issues. 

Ms. Davis received her Juris Doctor, cum laude, from Temple University, Beasley School of Law, where she served as a Staff Editor of the Temple Law Review and on the executive board of the school’s Health Law Society. During law school, she also interned with...

202-861-1830