FDA’dan üç kritik medikal araç kılavuzu (İng)
The US Food and Drug Administration (FDA) has released three final guidance documents regarding the submission of nearly all medical device applications made to the agency. The guidance documents, released on 31 December 2012, pertain to three important aspects of the device submission process: submission, filing and acceptance of applications.
In the first guidance, eCopy Program for Medical Device Submissions FDA has set out to require companies to submit in duplicate an electronic version of a paper submission. The purpose of this guidance is to explain the new electronic copy (eCopy) Program for medical device submissions. Section 745A(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), added by section 1136 of the Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144), requires the submission of eCopies with the issuance of this final guidance. This guidance describes how the Food and Drug Administration (FDA) is implementing the eCopy Program under section 745A(b) of the FD&C Act. The inclusion of an eCopy is expected to improve the efficiency of the review process by allowing for the immediate availability of an electronic version for review rather than relying solely on the paper version.
In the second guidance, Refuse to Accept Policy for 510(k)s, FDA seeks to establish criteria it can use to refuse to accept for submission any 510(k) application that does not meet certain basic criteria established by the agency. The purpose of this document is to explain the procedures and criteria FDA intends to use in assessing whether a 510(k) submission meets a minimum threshold of acceptability and should be accepted for substantive review.This guidance document supersedes two existing guidance documents entitled “Center for Devices and Radiological Health’s Premarket Notification (510(k)) Refuse to Accept Policy” issued on June 30, 1993 and “510(k) Refuse to Accept Procedures, 510(k) Memorandum K94-1” issued on May 20, 1994. The move is intended to conserve agency resources by siphoning off those applications with effectively no chance of making it through the device review process due to serious problems or omissions, preserving staff time for reviewing products that are more likely to obtain agency clearance.
The third and final guidance, Acceptance and Filing Review for Premarket Approval Applications (PMAs), is similar to the above 510(k) guidance in that it seeks to divide the review of submissions into two parts: acceptance and filing. the PMA regulation (21 CFR 814.42(e)) identifies the criteria
that, if not met, may serve as a basis for refusing to file a PMA. These criteria were previously discussed in the guidance document “Guidance for Industry and FDA Staff: Premarket Approval Application Filing Review,” dated May 1, 2003 (2003 PMA Filing Guidance), which is now superseded by this guidance. These documents have been used by FDA staff and the device industry to help elucidate the broad preclinical and clinical issues that need to be addressed in a
PMA and the key decisions to be made during the filing process.