FDA requests your comments!! With concern about the quality, safety and continued effectiveness of medical devices which have been subjected to continued servicing, maintenance, refurbishment and possible alteration by Original Equipment manufacturers(OEMs) or 3rd party entities, FDA is finally reviewing its policy and is re-approaching the issue. FDA has asked for comments about the Regulations
One of the basic objectives of FDA is to provide needed safety and protection for American public. FDA is issuing an order to reclassify the Blood Lancets, considering the history of recognized blood borne pathogen transmission by blood lancets. FDA believes reclassification of the Blood lancets is necessary to provide reasonable assurance of safety and
A graduate of Duke University School of Medicine, Dr. Califf completed his residency in internal medicine at University of California and a fellowship in Cardiology at Duke University. Prior to his appointment as Commissioner, Dr. Califf has served as FDA’s Deputy Commissioner for Medical products and Tobacco from February 2015 and has provided executive leadership
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.
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
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