F2 Labs

F2 Labs can assist you with your CE, U.S. & Canadian Certification (UL/CSA) needs & more. From Medical, Laboratory & IT devices, we can help.

[F2 Labs @F2_Labs]

The FCC is moving forward with removing authorization of government controlled labs in China from performing FCC testing and certification.

https://t.co/kZtT51yCSz

[F2 Labs @F2_Labs]

Unsure if you device is medical. Read on to find out.

#FDA #electricalsafety #testlab #NRTL

https://t.co/8Fuh1NK3lr

[F2 Labs @F2_Labs]

Our very own President, Wendy Fuster, and our company, was recently featured in MedTech Business Review. Check it out!

https://t.co/TxTCCkrNbB

[F2 Labs @F2_Labs]

Need help in navigating your Essential Performance? We can help. Reach out today.

https://t.co/aqsbfoBbPI

[F2 Labs @F2_Labs]

The FDA has recently categorized an RF toothbrush as a Class II Medical Device. This is interesting because as technologies continue to evolve the FDA's classifications and guidance documents will need to evolve in kind. #FDA #testlab #EMC #electricalsafety

[F2 Labs @F2_Labs]

AI in Healthcare continuing to be a hot button topic.

https://t.co/VTx1m8AyAC

[F2 Labs @F2_Labs]

As technology advances, questions about AI in Healthcare are becoming more commonplace and the FDA has released guidance on how those systems should be used.

https://t.co/ODSINppsKL

[F2 Labs @F2_Labs]

Need assistance with getting your equipment in the field certified and labeled to satisfy an electrical inspector, we can help!

https://t.co/Ftc9wYb4df

[F2 Labs @F2_Labs]

https://t.co/HFchWQXelm

[F2 Labs @F2_Labs]

Are you a manufacturer of a device that contains a button cell or coin cell battery? Need help with compliance with Reese's Law? We can help!

https://t.co/np4k1081Us

[F2 Labs @F2_Labs]

The FCC is moving forward with banning certain testing labs from providing certification. In an NPRM issued in May, the Commission set forth plans to ban any testing lab with direct or indirect ownership of 10% or more by an entity on the "Covered List". #FCC

[F2 Labs @F2_Labs]

As we tweeted back on 2/29, the FDA is heavily scrutinizing third party test data from certain countries. Something to continue to pay attention to:

https://t.co/pxG4rs3jea

[F2 Labs @F2_Labs]

Recently the FDA passed amendments to it's regulations stipulating that IVDs (In-Vitro Diagnostic) are now considered medical devices subject to the same rules as other medical devices. Reach out to F2 Labs today to discuss your needs with this new regulation. #testlabs #FDA

[F2 Labs @F2_Labs]

On March 8, 2024 FCC Commissioner Geoffrey Starks sent letters to multiple online marketplaces giving instruction on how to identify and stop the unlawful sales of insecure IoT devices that violate FCC rules.

Contact F2 Labs to help with your FCC compliance needs. #fcc

[F2 Labs @F2_Labs]

This is the reason to come to an ASCA certified test lab like F2 Labs. Feel confident in your premarket submissions to the FDA.

https://t.co/Xf8THlHrpm

[F2 Labs @F2_Labs]

The FDA made this change to bring their requirements in line with those adopted by other regulatory agencies. 2

[F2 Labs @F2_Labs]

Relevant for manufacturers of medical devices is an update to the FDA's current good manufacturing practice (CGMP) for it's quality system regulation. The new requirement references ISO 13485 - Medical devices - Quality management systems - Requirements for regulatory purposes-1

[F2 Labs @F2_Labs]

The EU has proposed providing manufacturers of IVD equipment additional time to comply with the IVDR (In Vitro Diagnostic Medical Devices Regulation). Certain classes of devices now have up until 2029 to comply. Full press release here.

https://t.co/ueCsEJL1V7

[F2 Labs @F2_Labs]

Need assistance with navigating CE compliance, F2 Labs can help. Reach out today. https://t.co/a8EhxdnbUp
#CEMark #testlab #electricalsafety #EMC

[F2 Labs @F2_Labs]

In another example of enforcement of noncompliant radio products used on the market, the FCC has levied a $1.2 million fine against a New York City-based retailer. Reach out to F2 Labs if you have a product that requires FCC/EMC testing. We can help! #testlab #FCC #EMC