Submitted by kBLASTER Team on
by M. Elizabeth Bierman and Michele L. Buenafe for Morgan Lewis
Commentary on FDA's final guidance titled The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notification [510(k)] which states a single primary predicate is needed for a 510(k) submission, as well as no longer allowing "...
Submitted by kBLASTER Team on
by Ropes & Gray
Commentary on FDA's final guidance titled The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notification [510(k)] which states a single primary predicate is needed for a 510(k) submission, as well as no longer allowing "split predicate" 510(k) submissions. Excerpts from this commentary stated the following:
--Designation of a “primary...
Submitted by kBLASTER Team on
The kBLASTER database has been updated today with summaries for 510(k)s cleared in July 2014, as well as FDA splash pages from 510(k)s cleared in August 2014. If you have Saved Searches in your kBLASTER account that meet the parameters of today's imports into the kBLASTER database, you will shortly be seeing blue notification flags in your active kBLASTER account on those Saved Searches, as well as Alert email(s). With more than 58,000 510(k) summaries to choose from, including more than 76,000 splash pages, find your best single primary predicate fast, saving you time and money...
Submitted by kBLASTER Team on
by Varun Saxena for Fierce Medical Devices
Commentary on FDA's final guidance titled The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notification [510(k)] which states a single primary predicate is needed for a 510(k) submission...
Submitted by kBLASTER Team on
by Arezu Sarvestani for Mass Device
Commentary on FDA's final guidance titled The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notification [510(k)] which states a single primary predicate is needed for a 510(k) submission, as well as no longer allowing "split predicate" 510(k) submissions. Excerpts from this commentary stated the following:
...The "split predicate"...
Submitted by kBLASTER Team on
by Alex Gaffney, RAC, for RAPS Regulatory News Focus
Commentary on FDA's final guidance titled The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notification [510(k)]. Excerpts from this commentary stated the following:
...companies would rely on "a single predicate" for a finding of substantial equivalence (or SE), FDA said. The rest would simply bolster an application's...
Submitted by kBLASTER Team on
An update was posted by the FDA on "How to find and effectively use Predicate Devices". This update stated that "Manufacturers must identify a primary predicate device which is most similar to the device under review with respect to indications for use and technological characteristics" and that "the use of split predicates is inconsistent with the 510(k) regulatory standard"....
Submitted by kBLASTER Team on
Final guidance was published by FDA on July 28, 2014 titled The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notification [510(k)]. This guidance recommends the identification of a single primary predicate in all 510(k) submissions and has ruled that the use of "split predicates as inconsistent with the 510(k) regulatory standard". Multiple predicates are still allowed, but each predicate used must have identical...
Submitted by kBLASTER Team on
The kBLASTER database has been updated today with summaries for 510(k)s cleared in April, May and June 2014, as well as FDA splash pages from 510(k)s cleared in April-July 2014. If you have Saved Searches in your kBLASTER account that meet the parameters of today's imports into the kBLASTER database, you will shortly be seeing blue notification flags in your active kBLASTER account on those Saved Searches, as well as Alert email(s). With more than 58,000 510(k) summaries to choose from, including more than 76,000 splash pages, find your best single primary predicate fast, saving...
Submitted by kBLASTER Team on
The kBLASTER database has been updated today with summaries for 510(k)s cleared in January, February and March 2014, as well as FDA splash pages from 510(k)s cleared in January-April 2014. If you have Saved Searches in your kBLASTER account that meet the parameters of today's imports into the kBLASTER database, you will shortly be seeing blue notification flags in your active kBLASTER account on those Saved Searches, as well as Alert email(s).
With more than 58,000 510(k) summaries to choose from, including more than 76,000 splash pages, find your best single primary...