FDA Law Blog

SEPTEMBER 11, 2023

Lenz, Principal Medical Device Regulation Expert — On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents. In a statement released at the time, CDRH Director Jeffrey Shuren, M.D.,

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FDA Law Blog

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.

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FDA Law Blog

AUGUST 27, 2023

As industry is well aware, by the terms of the statute, the DSCSA’s interoperability provisions become effective ten years after its 2013 enactment, or on November 27, 2023. Drug manufacturers have had electronic systems in place since 2017. By Karla L.

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FDA Law Blog

FEBRUARY 15, 2023

FDA is making these updates in part due to recognition that some of the records and reporting requirements are unnecessary to comply with the Electronic Product Radiation Control (EPRC) program (sections 532, 534(a)(1), and 537(b) of the FD&C Act (21 U.S.C. The final rule will be effective February 21, 2023.

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FDA Law Blog

JANUARY 5, 2023

To date, regulatory enforcement litigation focused on actual or imminent patient harm has taken a backseat to cybersecurity as FDA continues to update and implement its oversight framework. Digital providers and manufacturers not only have the concerns of the FDA to consider, but those of the FTC as well.

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FDA Law Blog

MAY 21, 2024

Public comments must be submitted electronically or postmarked on or before July 22, 2024, 60 days after publication in the Federal Register. 29, 2023) (“Basis”); NPRM at 44,603. In 2023, HHS conducted a different approach, a two-part test, to determine whether marijuana has a CAMU. 21 U.S.C. §

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