510(k) definition
510(k) means (a) any premarket notification and corresponding FDA clearance for a Device pursuant to FDA regulations, (b) all substantially equivalent or similar notifications, applications and clearances with respect to any other non-United States Regulatory Authority, including the EMA, HPRA, and Health Canada, ANVISA and (iii) all amendments, supplements and other additions and modifications thereto, and all documents, data and other information concerning any applicable Device which are necessary for, filed with, incorporated by reference in, or otherwise supportive of any of the foregoing.
510(k) means a pre-market notification submitted to the FDA for clearance under Section 510(k) of the FD&C Act, 21 U.S.C. § 360(k), and 21 C.F.R. Part 807, Subpart E.
510(k) means a Premarket Notification submission filed with the FDA in compliance with Section 510(k) of the Food, Drug and Cosmetic Act of 1938, as amended, per the requirements defined in 21 CFR Part 807 at least 90 days before the commercial distribution is to begin.
Examples of 510(k) in a sentence
VERADERMICS shall have the sole opportunity to challenge any order of a regulatory or governmental activity affecting its IND, ND A, BLA, IDE, 510K, PMA or any Project.
SPONSOR may, from time to time, transfer and THERAPEUTICS may assume all or some of the specific responsibilities of SPONSORS described in 21 CFR 812 Subpart C as “Sponsor” for medical devices that are the subject of an IDE, 510K or PMA.
More Definitions of 510(k)
510(k) means a marketing authorization issued by the FDA pursuant to Section 510(k) of the Act, whereby the FDA clears a medical device for sale in the United States, determining that the medical device is substantially equivalent to legally marketed predicate devices.
510(k) means a premarket notification submission to the FDA for determination that a medical device is substantially equivalent to another legally U.S. marketed medical device prior to such device being marketed.
510(k) has the meaning specified in Section 4.17(d) hereof.
510(k) as used herein shall mean a submission route to register a Device for marketing as defined by the FDA or foreign equivalent.
510(k) means an application filed with FDA pursuant to § 510(k) of the Medical Device Amendments of 1976 to the Federal Food, Drug and Cosmetic Act to initiate marketing and sales in the U.S.
510(k) means (i) any premarket notification and corresponding FDA order of substantial equivalence, or 510(k) clearance, for a Device pursuant to the FD&C Act, and FDA regulations, (ii) all substantially equivalent or similar notifications, applications, marketing authorizations and clearances, including CE Mark, with respect to any other non-U.S. Regulatory Authority, including Competent Authorities in Europe, and (iii) all amendments, supplements, letters to file and other additions and modifications thereto, and all documents, data and other information concerning any applicable Device which are necessary for, filed with, incorporated by reference in or otherwise support any of the foregoing.
510(k) means submission made to FDA to demonstrate that the device to be marketed is safe and effective and would satisfy the requirements as defined in U.S. FDA FD&C Act Section 513(i)(1)(A) (or any U.S. successor legislation) or similar regulations in any other country outside the U.S.;