Replies to post #45804 on Bioelectronics Corp (BIEL)

[cashpot]

@seven-up read it already nope has nothing to do with beil its some other type of device. Its a shame how these people drag their feet for years it takes them forever and a day to do their job Smdh

[seven-up]

Food and Drug Administration

Rules


Premarket Approval for Automated External Defibrillator Systems; Requirement Effective Date

Scheduled to be published on 01/29/2015 as document 2015-01619

I will look back at that I was looking at this it is on the 515 Project Status, final something moving to Final rule.
I was going to finish looking a labeling new rules.


Food and Drug Administration

Rules


Premarket Approval for Automated External Defibrillator Systems; Requirement Effective Date

Scheduled to be published on 01/29/2015 as document 2015-01619

Notices

Meetings:


Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics; Public Workshop

Scheduled to be published on 01/29/2015 as document 2015-01625

Agency Information Collection Activities; Proposals, Submissions, and Approvals:


Appeals of Science-Based Decisions Above the Division Level at the Center for Veterinary Medicine

Scheduled to be published on 01/29/2015 as document 2015-01669


Blood Establishment Registration and Product Listing

Scheduled to be published on 01/29/2015 as document 2015-01670


Class II Special Controls Guidance Document; Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Principle

Scheduled to be published on 01/29/2015 as document 2015-01626


Medical Device Labeling Regulations

Scheduled to be published on 01/29/2015 as document 2015-01668