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HIPAA/HITECH Compliance Strategies for Medical Device Manufacturers

As computing power continues to become cheaper and more powerful, medical devices are increasingly capable of handling larger and larger sets of data. This provides the ability to log ever expanding amounts of information...more

8/21/2013 - Biotechnology Compliance Covered Entities FDA HIPAA HITECH Manufacturers Medical Devices Pharmaceutical

Will an FDA Rule Make People Sick? - FDA Establishes a Rule on the Labeling of "Gluten Free" Foods that Sets a Limit Above What...

On August 5, 2013, the U.S. Food and Drug Administration published a final rule on the labeling of foods as “gluten free.” Gluten is a protein composite found in wheat, rye, barley, and their crossbred hybrids. Gluten gives...more

8/7/2013 - Celiac Disease FDA Food Labeling Food Safety Gluten-Free

Cybersecurity: FDA Risks for Medical Devices

On Thursday, June 13, 2013, the U.S. Food and Drug Administration (“FDA”) released a draft guidance on measures to help ensure the cybersecurity of medical devices. ...more

6/17/2013 - Cybersecurity DHS FDA HIPAA HITECH Medical Devices Software

Thoughts on Regulatory Constraints of Business Models

I am often called upon to address the nature of how regulatory controls may apply to the organization of healthcare companies in their ability to create, deliver, and capture value (their ‘business models’). While no...more

4/8/2013 - Business Development FDA Healthcare HIPAA HITECH Medical Devices Pharmaceutical Software Technology

The Impact of Cloud Computing on FDA's Regulation of Medical Products

The following blog article is drawn from the upcoming book Cloud Computing Deskbook, which is set to be released by Thomson Reuters West next summer. Cloud Computing Deskbook covers the legal and regulatory aspects of cloud...more

2/15/2013 - Cloud Computing FDA

FDA Issues Two Proposed Rules That Will Significantly Change Regulatory Requirements For Food Safety

The FDA Food Safety Modernization Act (FSMA), which was signed into law by President Obama on January 4, 2011, proposes the most sweeping reform of U.S. food safety laws in more than 70 years. As part of the changes...more

2/5/2013 - FDA Food Manufacturers Food Safety FSMA Safety Precautions

FDA Issues Final Guidance on Filing PMAs and 510(k)s

On December 31, 2012, the U.S. Food and Drug Administration (FDA) issued two new guidance documents on the minimum threshold of acceptability for medical device premarket submissions, which are titled “Refuse to Accept Policy...more

1/5/2013 - FDA Medical Devices Premarket Approval Applications

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