Blog Electronics Manufacturing Provider 
FDA Law
FEBRUARY 9, 2024
We previously blogged on the draft guidance ( here ) and on FDA’s broader framework for Digital Health Technologies (DHT) ( here and here ). The final guidance provides additional discussion with respect to DHTs that meet the definition of a device.
FDA Law
AUGUST 8, 2023
All of these deviations discussed in FDA inspectional observations and Warning Letters have caused serious issues for manufacturers of APIs or finished drug products. Perhaps most importantly, the guidance concludes with examples of how manufacturers would apply this framework to Nitroso compounds.
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FDA Law
MARCH 8, 2023
By Véronique Li, Senior Medical Device Regulation Expert — On March 17, 2023, enhancements to FDA’s electronic Medical Device Reporting (eMDR) system will go live. Manufacturers who submit reports via the FDA Electronic Submissions Gateway are being advised to update their systems by this time.
FDA Law
SEPTEMBER 22, 2024
See our prior blog post summarizing the different phaseout stages and categories of enforcement discretion. Instead, we focus here on the few notable statements that provide new or more detailed guidance than FDA has previously offered. By Steven J. Gonzalez & Lisa M. There is no cost associated with obtaining an FEI Number.
FDA Law
JULY 20, 2021
FTC concluded that none of the comments provided a compelling basis to change the substantive requirements of the proposed rule. listing “made,” “manufactured,” “built,” “produced,” “created,” or “crafted” in the United States or in America). The rule does not set a new standard for MUSA claims. However, this list is not exhaustive.
FDA Law
SEPTEMBER 11, 2023
The electronic Submission Template and Resource (eSTAR) program, which we blogged about here and here , also makes the highlight reel given its aim to improve consistency and efficiency in how 510(k)s are prepared. Over the years, we’ve blogged on similar initiatives related to the 510(k) pathway.
FDA Law
JUNE 27, 2023
Walsh — Last fall, we blogged about the process FDA uses to review allegations of regulatory misconduct against device manufacturers, suggesting greater transparency on the FDA process was needed (see here ). As we discussed in our prior blog post, there needs to be a better way to understand the outcome of FDA’s review.
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