FDA Issues Guidance on “Abbreviated” and “Special” 510(k) Pathways
The U.S. Food and Drug Administration (FDA) has issued two new guidance documents related respectively to an “abbreviated” and a “special” approach to the typical 510(K) process for medical devices.
The FDA describes the usual 510(K) process as “a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device…that is not subject to premarket approval.” According to the FDA, “Each person who wants to market in the U.S., a Class I, II, and III device intended for human use, for which a Premarket Approval application (PMA) is not required, must submit a 510(k) to FDA unless the device is exempt from 510(k) requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) .”
Now, two recent guidance documents issued by the FDA allow for altered 510(K) approaches for certain medical devices. The first guidance, issued September 13, 2019, is for a “Special 510(K) Program.” The FDA describes this program as “an optional pathway for certain well-defined device modifications where a manufacturer modifies its own legally marketed device, and design control procedures produce reliable results that can form, in addition to other 510(k) content requirements, the basis for substantial equivalence (SE).” The guidance is intended to clarify “the types of technological changes appropriate for review as Special 510(k)s.” The new guidance also supersedes prior FDA guidance from 1998 regarding Special 510(k) policy in “The New 510(k) Paradigm: Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications.”
This MDDI article purports to offer a “handy checklist” to determine “if changes made to your medical device can be reviewed under the [Special 510(K)] program.” Some of the questions listed on the article’s checklist include the following:
- Is it a change to the manufacturer’s own device?
- Are performance data needed to evaluate the change?
- Is there a well-established method to evaluate the change?
- Can the data be reviewed in a summary or risk analysis format?
The second FDA guidance, also issued September 13, 2019, is for the “Abbreviated 510(K) Program.” The FDA describes the program as “an optional approach that may be used to demonstrate substantial equivalence in premarket notifications (510(k)s)” and that “uses guidance documents, special controls, and/or voluntary consensus standards to facilitate FDA’s premarket review of 510(k) submissions.” The guidance is “intended to facilitate 510(k) submission preparation by manufacturers and review by FDA.”
A copy of the guidance for the Special 510(K) Program can be found here, and a copy of the guidance for the Abbreviated 510(K) Program can be found here. The FDA currently states that comments on either guidance may be submitted at any time. Public comments on the guidance for the Special 510(K) Program may be submitted here and for the Abbreviated 510(K) Program here.
First Ever Marijuana-Related Medical Device Approved
According to PR Newswire, the Israeli Ministry of Health has granted initial approval to Tel-Aviv-based Kanabo Research for their VapePod vaporizer product as a medical device. PR Newswire notes that with this approval, Israel has become the first country in the world to grant medical device approval for a “vaporizer for the use of medical cannabis extracts and formulations.” High Times, a cannabis-related publication, goes further to say that this is the first certification of marijuana “‘paraphernalia’ as an accepted medical device.”According to Israel21c, Kanabo claims that the approved vaporizer will provide for “more effective, consistent, and accurate dosing and delivery methods than currently accepted medical cannabis treatment methods.” Cannabis administration “has long frustrated doctors due to lack of precise dosage” according to The Jerusalem Post. It reports that Kanabo says the VapePod will solve this problem with its “consistent and accurate gauge.” Moreover, The Jerusalem Post notes that many medical cannabis patients inhale by smoking, and that vaporizers “reduce health risks and make inhalation more effective.”
Israel21c also reports that Kanabo’s next version of the approved VapePod – the VapePod MD, will “monitor patient usage and gather usage data for caregivers, doctors and research applications. PR Newswire reports that Kanabo has initiated pre-clinical trials and is “achieving impressive results in early findings” with their targeted formulations for sleep disorders that are designed to be used with the approved VapePod. Kanabo also has two patents pending which are directed to the formulations according to PR Newsire.
Kanabo Research was founded in 2016 and currently employs 12 people according to The Jerusalem Post. Co-Founder and CEO of Kanabo Research Avihu Tamir had this to say about the future of the company: “We expect that due to the transition of most of the cannabis consumers to the use of vaporizers, our company is projected to reach $10 million in sales within three years in the Israeli market, while the Israeli cannabis market is expected to reach $100 million in sales within three years. The Israeli market is a platform to deliver our technology to global markets in North America and Europe.”
Share