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News and Info

16 Jun

Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions!!

Draft Guidance for your comments This draft guidance document provides clarity for FDA staff and industry regarding the benefit and risk factors FDA may consider in prioritizing resources for compliance and enforcement efforts to maximize medical device quality and patient safety. FDA believes that explaining the factors listed in this draft guidance document will improve

10 Jun

Dissemination of Patient-Specific Information from Devices by Device Manufacturers

This FDA draft guidance provides recommendations to industry, healthcare providers, and FDA staff about the mechanisms and considerations for device manufacturers to facilitate the appropriate and responsible dissemination of patient-specific information recorded, stored, processed, retrieved, and/or derived from medical devices from manufacturers and sharing such information with patients when they request it. FDA believes that

27 May

Get your food defense plans ready!!

May 27, 2016 - 9:10 pm
FDA Updates, Food Industry

FSMA Final Rule for Mitigation Strategies to Protect Food against Intentional Adulteration!! The FDA Food Safety Modernization Act (FSMA) final rule is aimed at preventing intentional adulteration from acts intended to cause wide-scale harm to public health, including acts of terrorism targeting the food supply. Rather than targeting specific foods or hazards, this rule requires

06 Apr

FDA Final Rule on Sanitary Transportation of Human and Animal Food

As a part to protect the people from various illnesses resulting from food contamination during transportation because of unsanitary transportation practices, FDA issued a final rule on Sanitary Transportation of human and animal food. The Final rule is the sixth major rule under the Food Safety Modernization Act (FSMA). The rule strengthens the Sanitary Food

30 Mar

Latest Warning Letter Trend for Cosmetic Manufacturers

Since the issuance of 2013 revised FDA Guidance “Cosmetic Good Manufacturing (GMP) Guidelines/Inspection Checklist”, FDA enforcement of cosmetic manufactures has been steadily on the rise. FDA has always used warning letters as an effective compliance mechanism to let companies know that they have violated the laws and to tell them what corrective action they need

20 Mar

Don’t Make Claims On Cosmetic Products!

FDA Issues Warning Letters for making drug claims on Cosmetic Products FDA has always used warning letters as an effective compliance mechanism to let companies know that they have violated the laws and to tell them what corrective action they need to take. Over the years, FDA has issued a number of warning letters directed

10 Mar

Make your Old Medical Device “New” Again

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

03 Mar

General and Plastic Surgery Devices; Reclassification of Blood Lancets

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

24 Feb

Meet the New Commissioner of FDA Food & Drug, Mr. Robert M. Califf, M.D.

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

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