Blog2025-08-12T11:54:14-03:00
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FDA extends the implementation period for the UDI rule for CLASS I

FDA: implementation of the UDI rule The FDA is communicating today through the publication of a new guidance, the second extension of the deadline for compliance with the UDI rule for class I and unclassified devices*, especially because of the COVID-19 pandemic. The Agency believes [...]

Deadline for implementing UDI for CLASS I devices

The DEADLINE for implementing UDI for CLASS I devices before FDA is CLOSE! Under FDA, compliance with the UDI rule for class I devices becomes mandatory as of September 24, 2020. That date that was initially, September 24, 2018, has already been postponed by 2 [...]

Electronic format with FDA

Medical devices submissions pass to electronic format with FDA In an effort to improve the effectiveness of the medical device-related pre-market submission program, the FDA today issued the Final Rule, which amends existing pre-market regulations and now requires that submissions only occur in electronic format, [...]

Events: goods destined for distribution and more

Resolution RDC n. 13, of January 27th, 2004 - Goods intended for exposure, demonstration or distribution at fairs or events At the last Hospitalar fair that occurred in May 2019 in São Paulo/SP, Anvisa seized several irregular products and closed some stands. One of the [...]

The FDA: cleaning and steam sterilization the IFU

The FDA and its peculiarities in the cleaning and steam sterilization processes recommended in the IFU Medical products that must be cleaned and steam sterilized (autoclave) prior to use or in the case of thermolabile products, cleaned and disinfected prior use, are those marketed as non-sterile [...]

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