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Posted 12 July 2012 | By Alexander Gaffney, RAC
The US Food and Drug Administration (FDA) has released new draft guidance for medical device manufacturers looking to meet with the agency in advance of submitting a wide range of device applications.
Once finalized, the guidance-which formerly only covered Investigational Device Exemption (IDE) applications-will include 510(k) premarket notification applications, premarket approval (PMA) applications and Humanitarian Device Exemption (HDE) applications.
FDA explained in its 12 July Federal Register posting that while the meetings themselves have been common for quite some time, the scope of the guidance has remained unchanged since 1995 and is in dire need of an update to reflect its broader scope and incorporate additional changes.
Other planned changes include providing guidance on whether a clinical study requires an IDE, covering medical devices regulated by FDA's Center for Biologics Evaluation and Research (CBER), and a name change for the program.
The program, formerly known as the Pre-IDE program, will instead be called the Pre-Submission (Pre-Sub) program, though its purpose will remain largely the same, FDA said.
"The main purpose of the Pre-Sub program remains the same as the pre-IDE program: to facilitate providing advice to applicants when they have specific questions during product development and early protocol planning, about device studies that present significant risk(s) (SR) as well as non-significant risk(s) (NSR) or when developing protocols for clinical studies conducted outside of the United States to support future U.S. marketing applications," FDA wrote.
"Consequently, the Pre-Sub program can provide an efficient path from device concept to market," it concluded.
Included in the draft guidance is information pertaining to the best types of information to include with pre-submission dossiers, an outline of FDA's preferred process for when to schedule Pre-Sub meetings, and its expectations for the advice it dispenses to applicants.
"FDA intends to provide the best possible advice in accordance with the information provided, ensure it is captured accurately in the meeting minutes drafted by the sponsor, and commit to that advice unless the circumstances sufficiently change such that our advice is no longer applicable, such as when a sponsor changes the intended use of their device after we provide feedback," the agency explained in the Federal Register posti
FDA notes its ability to hold meetings is largely contingent upon its resources, which are often strained. The agency estimates the Center for Devices and Radiological Health (CDRH) will receive more than 2,400 Pre-Sub meeting requests, while CBER will receive 79. Each meeting is estimates to involve 137 hours of work per applicant.
FDA - Draft Guidance for Industry and FDA Staff Medical Devices: The Pre-Submission Program and Meetings with FDA Staff
FDA - Draft Guidance for Industry and Food and Drug Administration Staff: Medical Devices; The Pre-Submission Program and Meetings with FDA Staff
Tags: Pre-IDE, Pre-Sub, HDE, IDE, Latest News, 510(k), PMA, draft guidance, guidance, medical device