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FDA Guidance Advises Device Makers to Think About Home-Use
Medical device manufacturers would be well-advised to address any potential risks associated with home-use products at t [...]
FDA Spreads Regulatory Love Nationwide
Detroit may be struggling with bankruptcy. However, in a flurry of activity that would make industrialist Henry Ford pro [...]
Time to Take a Closer Look at FDA MDDS Moves
The FDA recently released a new draft guidance document for Medical Device Data Systems (MDDS). The FDA defines MDDS as [...]
FDA Lets MDDS Off The Regulatory Hook
FDA won't enforce compliance with regulatory controls that apply to medical image storage devices (MDDS) and medical ima [...]
FDA Guidance on How to Address Inaccurate Online Claims Against Medical Device or Drug Manufacturers
Distilling the FDA Guidance on How to Address Inaccurate Online Claims Against Medical Device or Drug Manufacturers: If [...]
FDA Acts to Harmonize Global Adverse Event Reporting
FDA Acts to Harmonize Global Adverse Event Reporting - It's a small world after all. One of the by-products of globaliza [...]
