September 2014

FDA webinar transcript on recent The 510(k) Program Guidance: Evaluating Substantial Equivalence in Premarket Notifications

Submitted by kBLASTER Team on

A recent FDA webinar distributed slides and an audio recording with transcript, which was intended to clarify recently released guidance titled The 510(k) Program Guidance: Evaluating Substantial Equivalence in Premarket Notifications. As described in a previous posting, issues regarding primary predicates and split predicates were discussed heavily.

Both the recorded transcript and slides presented in webinar by Marjorie...

FDA Guidance on Evaluating Substantial Equivalence in 510(k) Submissions (includes commentary on reference devices)

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 as reported in previous posting states a single primary predicate is needed for a 510(k)...

FDA issues "How to find and effectively use Predicate Devices" which states primary predicate is a must, Manufacturers may identify reference devices within their 510(k) to support scientific methodology or standard reference values

Submitted by kBLASTER Team on

An update was posted by the FDA on "How to find and effectively use Predicate Devices". A previous posting indicated a single primary predicate is needed and that "the use of split predicates is inconsistent with the 510(k) regulatory standard".  It...

kBLASTER database update September 2014--Find your primary predicate for a successful 510(k) submission fast

Submitted by kBLASTER Team on

The kBLASTER database has been updated today with additional summaries for 510(k)s cleared in August 2014, as well as FDA splash pages from 510(k)s cleared in September 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...

FInal Guidance for Industry and Food and Drug Administration Staff - The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]

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)]. As reported in previous posting, guidance recommends the identification of a single primary predicate in all 510(k) submissions, has ruled that the use of "split predicates as...

FDA’s Substantial Equivalence Guidance Describes FDA’s Process for Evaluating Substantial Equivalence and Updates to the 510(k) Decision Flowchart

Submitted by kBLASTER Team on

by FDA & Life Sciences Practice Group for King & Spalding

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:

--"According to the SE Guidance, comparison to a single...

FInal Guidance for Industry and FDA Staff - The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]

Submitted by kBLASTER Team on

PDF link to 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 suggested calling out a single primary predicate in all 510(k) submissions.  Furthermore, this guidance has stated the use of "split predicates as inconsistent with the 510(k) regulatory standard". Guidance states that multiple predicates are still allowed, but each predicate included must have identical...