On July 7, 2021, the U.S. Food and Drug Administration (FDA) issued a final guidance regarding the form and content of unique device identifier (UDI) labeling. The guidance will assist labelers of medical devices and FDA-accredited issuing agencies (who operate systems for issuing UDIs used by labelers) in meeting the requirements under 21 CFR Part 801, Subpart B, and the Unique Device Identification System Final Rule, 78 FR 58786 (September 24, 2013) (UDI Rule).
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Before a medical device is brought to market, the FDA requires a premarket submission. For low risk devices, that submission is often via a 510(k), demonstrating that the device is at least as safe and effective as (substantially equivalent to) an already legally marketed device that is not subject to premarket approval.
As of December 30, 2019, certain Class I and Class II medical devices and systems that previously required a 510(k) submission are now, based on certain criteria detailed in the FDA’s rule, exempt from that requirement. The regulatory adjustment will mean that the dozens of medical devices and test systems identified will no longer have to comply with the premarket clearance, subject to certain conditions.
For example, among the impacted items are numerous drug detection systems, such as amphetamine test systems, barbiturate test systems, benzodiazepine test systems, codeine test systems, and methamphetamine test systems, all of which are exempt unless they are intended for any other use than employment, insurance, or federal drug testing programs. The new rule also affects other categories of devices and tests, such as unscented menstrual pads, assisted reproduction accessories and microtools, and breath-alcohol test systems.
This was originally published in Law360.
With the advancements in technology and the advent of artificial intelligence, the medical device industry is flourishing. But regardless of the type of technology involved, the U.S. Food and Drug Administration must clear the device for marketing before any commercialization of a medical device.
There are typically three mechanisms for seeking FDA clearance for a medical device: a 510(k) submission, a de novo classification request and a premarket approval application. The FDA will not accept a 510(k) application unless the applicant can demonstrate that the device is at least as safe and effective (i.e., substantially equivalent to) a device that has already obtained FDA clearance (i.e., a predicate device).
For the full article by Frederick R. Ball and Carolyn A. Alenci, visit the Duane Morris LLP website.
The 510(k) process provides a review procedure for marketing clearance of devices that are “substantially equivalent” to other approved devices or to a standard recognized by the Food and Drug Administration (FDA).
On September 6, 2018, the FDA launched an alternate to the Traditional 510(k) for submitting a Premarket Notification (510(k)). The FDA calls the alternative the Quality in 510(k) “Quik” Review Program Pilot. Under the program, the FDA’s goal is “to make a final decision within 60 days.”
Read the full text of this Alert on the Duane Morris LLP website.