On December 4, 2018, the U.S. Food and Drug Administration announced a proposal that it intends to improve the review process for new low to moderate-risk medical devices. It remains to be seen whether the proposal will adequately protect consumers, or whether the form it will take if it is ultimately enacted.
FDA review process for low and moderate-risk devices
The FDA has two different pathways for low- and moderate-risk medical devices to gain approval. By far, the most extensively-used pathway is the 510(k) process, under which a new device may receive clearance without extensive testing if it can be shown that the device is substantially equivalent to another device already on the market. The less commonly-used pathway, which is the subject of the December 4th announcement is the De Novo review.
Changes to De Novo review for medical devices
Unlike the 510(k) pathway, with the De Novo pathway the FDA reviews Class I and Class II medical devices as novel submissions not substantially related to something that has already been approved. After approval, the FDA creates a classification for the device. If necessary, it also creates a regulation for it.
According to the FDA, the proposed changes to the De Novo pathway are intended to make the process more clear and efficient. If adopted, it would standardize a procedure and evaluation criteria for new medical devices, as well as the method of classifying new types of devices. FDA commissioner Scott Gottlieb commented that the changes are expected to encourage more medical device developers to pursue the de novo pathway.
Exact extent of proposed rule change is unclear
Though the proposal is meant to clarify the approval process, it does not explicitly explain the information that manufacturers will be expected to provide. However, it will include any previous submissions of the device that had already been made the the FDA, other medical devices that are potentially similar as well as an explanation of what makes it different from the submission, questions on why the manufacturer believes the device should be classified as low or moderate risk, an explanation of probable health risks, and known alternatives for tackling the same medical question that the device is intended to solve.
The proposed changes to the De Novo pathway were released shortly after the FDA announced a proposal to also modify the 510(k) review procedure. That announcement came on November 26, 2018, and is intended to take modern technology into account when reviewing devices based on older submissions, as well as improve transparency for the public and post-market surveillance.
The public has 90 days to comment on each of the proposed rules.
What to do after a medical device injury
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Additional FDA medical device review proposal resources:
- S. Food & Drug Administration, FDA In Brief: FDA proposes improvements to the De Novo pathway for novel medical devices to advance safe, effective and innovative treatments for patients, https://www.fda.gov/NewsEvents/Newsroom/FDAInBrief/ucm627522.htm
U.S. Food & Drug Administration, Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on transformative new steps to modernize FDA’s 510(k) program to advance the review of the safety and effectiveness of medical devices, https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm626572.htm