One of the basic objectives of FDA is to provide needed food safety protection for American public. Keeping food safe to eat is paramount, no matter where it is produced, whether conventional or organic, whether the operation is small, medium or large, whether it’s produce or processed foods. The FDA Food Safety Modernization Act (FSMA)
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
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
FDA announced an opportunity for public comment on the guidance document for Unique Device Identification Convenience Kits. Prior to the UDI rule, as per 21CFR 801.30 there was a general thinking that Medical procedure kits including orthopedic procedure kits are convenient kits. But the passage of UDI rule let to the interpretation that Implantable device,
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
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