This just in from the other board boys and girls.
Post# of 8475
(Total Views: 608)
Posted On: 01/22/2020 7:45:35 PM
This just in from the other board boys and girls. it’s starting to get interesting.!!!
Yep JGD, If your 510k reaches the 'Interactive Review' you are Golden!
I hope people understand the importance of this Full Body Musculoskeletal Clearance. BIEL has been working towards this moment for 19 years.
We were close in 2017 but the FDA ended up only Clearing the Foot and Knee. What happened when the Foot and Knee got Cleared? Dr. Scholl's wanted a Partnership for a Plantar Fasciitis Product. CVS wanted a Partnership for a Knee Product.
There were other interested Partners but they needed the Full Body Clearance. The time is almost upon us where BIEL can give those Partners a call and say, "We Got It".
Interactive Review
If the Lead Reviewer chooses to continue with an Interactive Review, this means the Lead Reviewer has determined that any outstanding deficiencies may be adequately addressed within the timeframe set by the Medical Device User Fee Amendment of 2012 (MDUFA III) performance goal for a 510(k) (90 FDA days) and that the submission will not be placed on hold. The Lead Reviewer communicates with the submitter during the Interactive Review using tools such as:
Email
Telephone Call
During Interactive Review, the Lead Reviewer may request additional information from the submitter, who may either send the information to the Lead Reviewer directly or to the DCC. Note: During Interactive Review, any information submitted to the DCC must include a valid eCopy.
Yep JGD, If your 510k reaches the 'Interactive Review' you are Golden!
I hope people understand the importance of this Full Body Musculoskeletal Clearance. BIEL has been working towards this moment for 19 years.
We were close in 2017 but the FDA ended up only Clearing the Foot and Knee. What happened when the Foot and Knee got Cleared? Dr. Scholl's wanted a Partnership for a Plantar Fasciitis Product. CVS wanted a Partnership for a Knee Product.
There were other interested Partners but they needed the Full Body Clearance. The time is almost upon us where BIEL can give those Partners a call and say, "We Got It".
Interactive Review
If the Lead Reviewer chooses to continue with an Interactive Review, this means the Lead Reviewer has determined that any outstanding deficiencies may be adequately addressed within the timeframe set by the Medical Device User Fee Amendment of 2012 (MDUFA III) performance goal for a 510(k) (90 FDA days) and that the submission will not be placed on hold. The Lead Reviewer communicates with the submitter during the Interactive Review using tools such as:
Telephone Call
During Interactive Review, the Lead Reviewer may request additional information from the submitter, who may either send the information to the Lead Reviewer directly or to the DCC. Note: During Interactive Review, any information submitted to the DCC must include a valid eCopy.
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