Proper maintenance of PACS can help the facility to save money. For proper maintenance and upkeep of PACS a facility should have a proper backup system available with well trained staff on how to perform the backup. The software should be always up to date and the manufacturers requirements about the hardware should be followed.
Industry Links The list below is meant to be a comprehensive list of important industry links that are helpful and useful for our clients. If you find a useful link that would be helpful to others, please email it to us (contact page), and we will try to include it on the list below. FDA
Insight Report Vol. 13 No.1 Prepared by: Aditya Sukthankar Background: A wide-ranging surveillance operation by the Food and Drug Administration against a group of its own scientists used an enemies list of sorts as it secretly captured thousands of e-mails that the disgruntled scientists sent privately to members of Congress, lawyers, labor officials, journalists and
New Changes to the FDA’s Device Registration and Listing Database NEWS FLASH!!! Guidance for “Transfer of a Premarket Notification (510(k)) Clearance” In December 2014, we posted an FDA Update on the new draft FDA guidance titled “Transfer of a Premarket Notification (510(k)) Clearance–Questions and Answers”. This guidance provided information on how to notify FDA of
FDA announced an opportunity for public comment on the guidance document for informed consent for in vitro diagnostic device studies using leftover human specimens that are not individually identifiable. FDA regulations do not contain exceptions from the requirements of informed consent on the grounds that the specimens are not identifiable or that they are remnants
On the same date, the Centers for Medicare and Medicaid Services (CMS) published a final rule that specifies the requirements that eligible providers and hospitals must meet to qualify for Electronic Health Record (EHR) incentive payments and solicits feedback about the Electronic Health Record (EHR) Incentive Programs going forward. Goal of this Activity: Incorporation of
The FDA new user fees for Fiscal Year 2016 (October 1, 2015 through September 30, 2016) are as follows: FY16 User Fees (in U.S. Dollars) Application Type Standard Fee Small Business Fee 510(k)‡ $5,228 $2,614 513(g) $3,529 $1,765 PMA, PDP, PMR, BLA $261,388 $65,347 panel-track supplement $196,041 $49,010 180-day supplement $39,208 $9,802 real-time supplement $18,297
Clients are being made aware of this new milestone development for the first time in the FDA’s history, through which FDA is establishing an advisory committee focused on patient engagement. The Patient Engagement Advisory Committee will provide advice on complex issues relating to medical devices, the regulation of devices, and their use by patients to
Starting Sept 2016 All our food clients are made aware that the FDA has finally released the final rules on two regulations that will affect the human and animal foods. These changes will be the most comprehensive and dynamic changes to the Food Industry since the 1970’s. The intent is to provide new Safety Requirements
NEWS FLASH!!! For those of those that ship FDA regulated devices out of the country we are familiar with export certificates. FDA has revised the payment requirements for export certificates, the fees are now: Original Certificates: $175 Subsequent Certificates issued for the same product(s): $85 The maximum number of pages for a certificate is now
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