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The FDA’s Center for Devices and Radiological Health (CDRH) released four final guidance documents on Thursday, Sept. 12, which provides the FDA’s current thinking on the Special 510(K) program, the Abbreviated 510(K) program, how to format Traditional and Abbreviated 510(K)s and the new Refuse to Accept policy for 510(K).
The March 1998 guidance "The New 510(K) Paradigm: Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications" is superseded by The Special 510(K) Program final guidance and The Abbreviated 5110(K) Program final guidance, issued on Sept 12, 2019. The release of the Special 510(K) Program final guidance follows CDRH’s launch of a pilot program in October 2018 on the expansion of the Special 510(K) program.
The Special 510(K) program offers 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).” CDRH says in the final guidance that the program was previously “ limited to review of changes that did not affect the devices’ intended use nor alter the devices’ fundamental scientific technology”, but now it focuses on “ whether the method(s) to evaluate the change(s) are well-established, and whether the results can be sufficiently reviewed in a summary or risk analysis format.”
The seven-page guidance for the Abbreviated 510(K) Program is published to follow the FDA’s effort to further expand the previously established Abbreviated 510(K) program. The Abbreviated 510(K) Program relies on the use of guidance documents, special controls, and/or voluntary consensus standards to facilitate FDA's premarket review of 510(K) submissions. The Abbreviated 510(K) approach described in this guidance document is intended to facilitate 510(k) submission preparation by manufacturers and review by FDA.
Every pharmaceutical company wants to maximize speed to market for a new drug product. One way to enable this is with a platform approach for the package and delivery systems – in other words, to use the same vial containment system and/or syringe system for multiple drug products. To use this approach effectively, component and system performance data is needed. Through the Integrated Solutions platform, West is ideally positioned to provide this data.
Since the 2012 New England Compounding Center tragedy that linked a deadly fungal meningitis outbreak to a failure to use current good manufacturing practices (cGMP),<sup>1</sup> compounding pharmacies have faced increasing scrutiny and regulation by the U.S. Food and Drug Administration (FDA). While registering with the FDA is still voluntary, only compounding pharmacies that register, and pass inspection, will be granted “503B” status as compounding outsourcing facilities under Section 503B of the Federal Food, Drug, and Cosmetic Act.<sup>2</sup>
A consequence of the sustained shift of treatment from hospital to home is the evolution of on-body delivery systems (OBDS). OBDS platforms can deliver high volumes of medicines subcutaneously which traditionally would have been administered intravenously via an infusion at a clinic under the supervision of a healthcare professional (HCP).
Defined under US FDA 21 CFR 3.2 (e)(2), a <em>co-packaged combination product</em> consists of “two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products”. (1) These device products can range from delivery devices, to bandages, to antimicrobial swabs. Understanding the regulations around such a wide range of devices can be challenging; drug companies often look to the device manufacturer/provider for guidance when filing.
While all major regulatory agencies have expectations regarding the ability of a pharmaceutical wash process to provide a suitable level of pre-sterilization depyrogenation, the United States (U.S.) Food and Drug Administration’s (FDA) requirements appear to be particularly stringent.
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