Premarket Notification Submission 510(k), Subpart E

OMB 0910-0120

OMB 0910-0120

This ICR collects information from persons who intend to market a medical device. Based on the information provided in the premarket notification (510(k)) submission, FDA determines whether a new device provides reasonable assurance of the safety and effectiveness of the device through substantial equivalence to a legally marketed device and whether the device can, therefore, be allowed to enter the U.S. market. Because the review of 510(k) submissions confirms that the new device is as safe and as effective as legally marketed predicate devices, potentially unsafe and/or ineffective devices, including those with fraudulent claims, are prevented from entering the U.S. market.

The latest form for Premarket Notification Submission 510(k), Subpart E expires 2023-06-30 and can be found here.

Latest Forms, Documents, and Supporting Material
All Historical Document Collections
Approved without change
Revision of a currently approved collection 2020-05-12
Approved without change
No material or nonsubstantive change to a currently approved collection 2019-12-16
Approved without change
Extension without change of a currently approved collection 2017-04-12
Approved without change
No material or nonsubstantive change to a currently approved collection 2016-03-25
Withdrawn and continue
No material or nonsubstantive change to a currently approved collection 2016-01-12
Withdrawn and continue
No material or nonsubstantive change to a currently approved collection 2015-05-01
Approved without change
No material or nonsubstantive change to a currently approved collection 2015-01-26
Approved with change
No material or nonsubstantive change to a currently approved collection 2014-10-27
Approved without change
Extension without change of a currently approved collection 2013-11-22
Approved without change
No material or nonsubstantive change to a currently approved collection 2013-11-12
Approved without change
No material or nonsubstantive change to a currently approved collection 2012-12-12
Approved without change
Revision of a currently approved collection 2010-08-17
Approved without change
Extension without change of a currently approved collection 2007-05-25
Approved with change
Extension without change of a currently approved collection 2004-03-19
Approved without change
Extension without change of a currently approved collection 2001-07-17
Approved without change
Reinstatement without change of a previously approved collection 1998-09-01
Approved with change
No material or nonsubstantive change to a currently approved collection 1993-02-24
Approved without change
Reinstatement with change of a previously approved collection 1991-10-17
Approved without change
Extension without change of a currently approved collection 1989-01-04
Approved without change
Reinstatement with change of a previously approved collection 1988-03-07
Approved without change
Revision of a currently approved collection 1986-10-23
Approved without change
Reinstatement with change of a previously approved collection 1985-03-15
Approved without change
Reinstatement with change of a previously approved collection 1984-08-06
Approved without change
Revision of a currently approved collection 1983-04-25
Approved without change
New collection (Request for a new OMB Control Number) 1981-01-28

© 2021 OMB.report | Privacy Policy