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News and Info

03 Feb

Enforcement Policy on National Health Related Item Code (NHRIC) and N​ational Drug Code (NDC) Numbers Assigned to Devices

Your chance to be heard!!FDA wants your comments FDA announced an opportunity for public comment on the guidance document, “Enforcement Policy on National Health related Item Code and National Drug Code Numbers Assigned to Devices”. The guidance highlights FDA’s intent to stop providing NHRIC and NDC number for Medical devices manufactured and Labeled prior to

26 Jan

Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices

FDA wants your comments!! Your chance to be heard!!!!! FDA announced an opportunity for public comment on the guidance document for Design Considerations and premarket Submission Recommendations for Interoperable Medical Devices. In today’s world where technology plays an important role, the Medical Device industry is bringing in new technologies in market. The Healthcare industry is

20 Dec

PACS: An Ounce of Investment in Your Patients.

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.

U.S. Industry Links

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

08 Dec

FDA Spying on its Own Scientists

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

30 Oct

Small Change with big Impact

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

27 Oct

FDA wants your comment!! – Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable

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

09 Oct

Incorporation of (UDIs) in Healthcare settings

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

30 Sep

The FDA new user fees for Fiscal Year 2016

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

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