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An investigational device exemption (IDE) allows an investigational device (i.e. a device that is the subject of a clinical study [1]) to be used in order to collect safety and effectiveness data required to support a premarket approval (PMA) application or a premarket notification [510(k)] submission to Food and Drug Administration (FDA). [2]
Section 510(k) [28] of the Federal Food, Drug, and Cosmetic Act requires those device manufacturers who must register to notify FDA, at least 90 days in advance, of their intent to market a medical device. This is known as premarket notification, PMN, or 510(k).
The term was borrowed from the FDA's 1976 substantial equivalence definition for new medical devices—under Premarket Notification 510(k), a new Class II device that is essentially similar to an existing device can be cleared for release without further testing.
PARSIPPANY, N.J., Jan. 07, 2025 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in the delivery of innovative, non-opioid pain therapies to transform the lives of patients, announced today that it has received clearance from the U.S. Food & Drug Administration (FDA) to market a new Smart Tip designed to access the medial branch nerves to manage chronic low back ...
In the US, evidence of effectiveness is required by the FDA and confirmed through either a Premarket Approval (PMA) [1] or similarity to a predicate device via a 510(k) Premarket Notification. [ 2 ] National deviations of this series of standards exist which include country specific requirements; [ 3 ] [ 4 ] see e.g. UL or AAMI for US specifics.
DEPARTMENT OF HEALTH AND HUMAN SERVICES OBSERVATION 2 There are no written procedures for production and process controls designed to assure that the drug products ...
The U.S. House of Representatives plans to vote on Tuesday on a bill supported by Republican President-elect Donald Trump to essentially ban transgender girls and women from competing in school ...
Best CD rates for Wednesday, February 12, 2025 (new look casting via Getty Images)