insights
FDA exempts more than 1000 devices from 510(k) premarket submissions.
The FDA announced a list of class II medical devices that are exempt from 510(k) premarket notification in July and noted that those with pending 510(k) submissions for devices that are now exempt from premarket notification, subject to the limitations on exemptions, should withdraw those submissions.
The FDA said it was making the announcement in accordance with the 21st Century Cures Act, passed in December 2016 and signed into law by President Barack Obama. That bipartisan law provides $6.3 billion intended to advance the research and development of new therapies and diagnostics and that represents a substantial federal investment in a wide range of health care priorities.
The Food and Drug Administration stated in the notice that exempting these devices from 510(k) filings will decrease regulatory burdens on the medical device industry and speed up the process of bringing new medical devices to market. The devices no longer needing premarket notification range from dentures to automated radiography collimators.
The medical device trade association AdvaMed praised the FDA for its action. “AdvaMed appreciates FDA’s efforts to implement risk based regulatory processes and promote increased regulatory efficiency through the identification of lower risk devices that may be appropriate for exemption from premarket notification,” the group wrote in response to the FDA’s request for comments on the proposed action.
In 2000, 510(k) applications typically were reviewed in an average of 96 days, but that number grew to 154 days by 2010 according to an analysis by medical device supplier Qmed. That trend could have been a factor in the FDA’s decision to examine a number of devices that could be eligible for exemption.
The action is one of several the Food and Drug Administration is undertaking to speed the approval process for a range of drugs and devices that are substantially similar to those that have already been approved and should allow the FDA to focus on drugs and devices that pose elevated risk to patients.
While freeing device-makers from 510(k) review for the listed devices, FDA in its announcement warned, "However an exemption from the requirement of premarket notification does not mean that the device is exempt from any other statutory or regulatory requirements, unless such exemption is explicitly provided by order or regulation."
You can access the notice in the Federal Register for a copy of the full list. If you are looking for an advisory partner, Kapstone Medical is well versed in regulatory planning, 510(k) submissions, CE Mark and quality systems development.
Visit our website KapstoneMedical.com or Call Us Today to learn more! Phone: (704) 843-7852 – email: info@kapstonemedical.com
