News

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

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

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)]

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...

US FDA Clarifies 510(k) Submission and Substantial Equivalence Requirements

by Stewart Eisenhart for Emergo Group

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:...

FDA Tightens 510(k) Program but Fast-Track for Medical Devices Remains

by Beau Hooks for DrugWatch

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 FDA states that there must be a primary predicate device cited in the 510(k) application to...

New 510(k) Guidance Bans ‘Split Predicates’

by Liza Burns for The Weinberg Group

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 release of the final version of this guidance cements certain changes to the core of the...

Final rule prohibits “split predicates” under 510(k) process

by Arezu Sarvestani for Mass Device, posted in OrthoSpine News

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:

..."Federal medical device regulators finalized a new...

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

A recent FDA webinar distributed slides and an audio recording with transcript, which was intended to clarify recently released guidance The 510(k) Program Guidance: Evaluating Substantial Equivalence in Premarket Notifications. This discussion included questions and answers from interested parties regarding a number of topics, including the specification of a single primary predicate in a 510(k) submission. This webinar was led by Marjorie Shulman [Director, Premarket Notification Program, Office of Device Evaluation (ODE), Center for Devices and Radiological Health...

kBLASTER database update August 2014 #2--Find your primary predicate for a successful 510(k) submission fast

The kBLASTER database has been updated today with additional summaries for 510(k)s cleared in July and August 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,...

Pages