FDA Lays Out New Guidelines for Medical Device Cybersecurity
With cyberattacks becoming increasingly common, the FDA has issued long-awaited draft guidance to help device makers deal with the threat.
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Device Makers to FDA: Give Us More Time for ISO 13485 Harmonization
On Feb. 23, the U.S. Food and Drug Administration (FDA) issued a proposed rule to harmonize its good manufacturing practices (CGMP) regulations for medical devices with International Standardization Organization (ISO) 13485. The basic proposal is to replace the...
New Deal Reached for MDUFA Medical Device User Fees
The FDA’s Center for Devices and Radiological Health says that the agency and industry have reached agreement on MDUFA V.
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One Year Is Not Enough to Harmonize Quality Systems with ISO 13485
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