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Previous Blogs

Regulations
Regulations Medical Devices Timelines
Timelines for Medical Device Regulation and Risk Assessment for Nitrosamines in Europe Extended

By Bettine Boltres, PhD.

May 05, 2020

We are living in very unpredictable times. The virus SARS-CoV-2 is keeping the global pharmaceutical industry, including regulatory agencies, very busy. The whole industry is working together in the development of treatments and vaccines. The process of getting these treatments approved and to patients as quickly as possible requires the undivided attention of regulatory agencies, such as the FDA and EMA. As a result, the following deadlines have been extended for certain other requirements.

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Regulatory Affairs FDA Guidances and Regulations Medical Devices 510(K)
The FDA released four final guidances pertaining to the 510(K) program

By Di Wu

December 17, 2019

The FDA’s Center for Devices and Radiological Health (CDRH) released four final guidance documents on Thursday, Sept. 12, which provides the FDA’s current thinking on the Special 510(K) program, the Abbreviated 510(K) program, how to format Traditional and Abbreviated 510(K)s and the new Refuse to Accept policy for 510(K).

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