News

kBLASTER database update January 2013--Find your primary predicate for a successful 510(k) submission fast

Submitted by kBLASTER Team on

The kBLASTER database has been updated today with 510(k) summaries from 510(k)s cleared in December 2012, as well as FDA splash pages from 510(k)s cleared in December 2012 and January 2013. If you have Saved Searches in your kBLASTER account that meet the parameters of any of the January 13th imports into the kBLASTER database, you will be seeing Alert email(s) in the near future, if you haven't already.

With more than 55,000 510(k) summaries to choose from, including more than 73,000 splash pages, find your best single primary predicate fast, saving you time and money on the...

CDRH Fiscal Year 2013 Proposed Guidance Development

Submitted by kBLASTER Team on

CDRH at FDA has indicated as part of MDUFA III that numerous “A-list” draft FDA guidance documents that are pertinent to the predicate selection process are intended to be released as final guidance in 2013, including:

The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications (draft guidance issued 12/27/11)

Refuse to Accept (RTA) Policy for 510(k) Submissions (first draft guidance issued 8/13/12, latest draft guidance issued...

kBLASTER database update December 2012--Find your primary predicate for a successful 510(k) submission fast

Submitted by kBLASTER Team on

The kBLASTER database has been updated today with 510(k) summaries from 510(k)s cleared in November 2012, as well as FDA splash pages from 510(k)s cleared in November and December 2012. If you have Saved Searches in your kBLASTER account that meet the parameters of any of the December 12th imports into the kBLASTER database, you will be seeing Alert email(s) in the near future, if you haven't already.

With more than 55,000 510(k) summaries to choose from, including more than 73,000 splash pages, find your best single primary predicate fast, saving you time and money on the path...

kBLASTER is a Registered Trademark with USPTO

Submitted by kBLASTER Team on

kBLASTER® is a now a registered trademark with the United States Patent and Trademark Office.  "I want to thank my development partners and legal team in moving this forward to fruition," said Eric Eggers, Founder and CEO of kBLASTER.  "But most of all I want to thank the customers who by their purchases of kBLASTER subscriptions have made this registration possible. I am excited to hear their positive feedback on utilizing kBLASTER and we are working hard to improve the kBLASTER experience even further."

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kBLASTER database update November 2012--Find your primary predicate for a successful 510(k) submission fast

Submitted by kBLASTER Team on

The kBLASTER database has been updated today with FDA 510(k) summaries from 510(k)s cleared in October 2012, as well as FDA splash pages from 510(k)s cleared in November 2012. If you have Saved Searches in your kBLASTER account that meet the parameters of any of the October 26th imports into the kBLASTER database, you will be seeing Alert email(s) in the near future, if you haven't already.

With more than 55,000 510(k) summaries to choose from, including more than 73,000 splash pages, find your best single primary predicate fast, saving you time and money on the path to a...

kBLASTER database second update October 2012--Find your primary predicate for a successful 510(k) submission fast

Submitted by kBLASTER Team on

The kBLASTER database has been updated today with 6 FDA 510(k) summaries from 510(k)s cleared in October 2012, as well as 109 FDA splash pages from 510(k)s cleared in October 2012. If you have Saved Searches in your kBLASTER account that meet the parameters of any of the October 26th imports into the kBLASTER database, you will be seeing Alert email(s) in the near future, if you haven't already.

With more than 55,000 510(k) summaries to choose from, including more than 73,000 splash pages, find your best single primary predicate fast, saving you time and money on the path to a...

kBLASTER database update October 2012--Find your primary predicate for a successful 510(k) submission fast

Submitted by kBLASTER Team on

The kBLASTER database has been updated today with 238 FDA 510(k) summaries and 246 FDA splash pages from 510(k)s cleared in September 2012, as well as 50 FDA splash pages from 510(k)s cleared in October 2012.  If you have Saved Searches in your kBLASTER account that meet the parameters of any of the October 10th imports into the kBLASTER database, you will be seeing Alert email(s) in the near future, if you haven't already.

With more than 54,000 510(k) summaries to choose from, including more than 72,000 splash pages, find your best single primary predicate fast, saving you...

kBLASTER Launches a Revolution in 510(k) Predicate Searching

Submitted by kBLASTER Team on

kBLASTER launched a revolutionary search engine that polls the entire contents of all available 510(k) Food and Drug Administration summaries. That makes kBLASTER the best existing tool for performing primary predicate searches quickly and with precision, which ultimately saves time and money during the 510(k) clearance process.

Successful clearance of 510(k) applications hinges on the quality of predicate selection, and kBLASTER is the right tool for the job. This custom-built search engine was designed to...

Proposed 510(k) guidance from FDA requires agency response to applicant in 15 days

Submitted by kBLASTER Team on

by Arundhati Parmar for Med City News

Commentary on regulatory implications of FDA Draft Guidance for Industry and Food and Drug Administration Staff - Refuse to Accept Policy for 510(k)s.  This proposed guidance to expedite the acceptance process for the 510(k) program at the FDA would require the agency to respond in 15 days to an applicant and signals a marked shift to almost 20 year old guidance regarding 510(k) acceptance policy...

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