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. Thus, these regulations apply to a huge variety of products.

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FDA Law Blog

JANUARY 5, 2023

Claud — As we turn into the New Year, we offer a few items of interest in digital and telehealth regulation, enforcement, and compliance that may provide some helpful guideposts for stakeholders. Digital providers and manufacturers not only have the concerns of the FDA to consider, but those of the FTC as well. By John W.M.

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FDA Law Blog

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.

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FDA Law Blog

DECEMBER 6, 2024

The draft guidance includes FAQs covering topics from across disciplines: regulatory review; chemistry, manufacturing, and controls (CMC); nonclinical and pharmacology/toxicology (PT); clinical; and clinical pharmacology. and create a new guidance to help CGT sponsors more efficiently find their way to the correct answers.

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FDA Law Blog

SEPTEMBER 27, 2023

FDA intends to provide preliminary responses to Type D meeting packages no later than 5 calendar days before the meeting date. In fact, it seems to us that the Type D meeting provides an opportunity to elicit iterative input from the Agency given that many Type C meetings and even some Type B meetings are being granted as WRO in recent years.

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FDA Law Blog

JULY 7, 2024

Laboratories struggling to understand the myriad implications of being regulated as device “manufacturers” were hopeful that additional guidance would shed light on how to apply FDA’s existing medical device regulatory framework to their operations. 803), Reporting of Corrections and Removals (21 C.F.R. § 806) and Complaint Files (21 C.F.R.

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FDA Law Blog

JANUARY 8, 2023

The report must also discuss the barriers associated with conducting research with cannabis and CBD in states that have legalized their use, how barriers might be overcome and whether public-private partnerships or federal-state partnerships can or should provide researchers with additional cannabis and CBD strains. Application Process.

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FDA Law Blog

MAY 21, 2024

The Attorney General also released DOJ’s Office of Legal Counsel (“OLC”) opinions providing the rationale and support for the NPRM. Public comments must be submitted electronically or postmarked on or before July 22, 2024, 60 days after publication in the Federal Register. 44,597 (May 21, 2024). 21 U.S.C. § Basis at 24.

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Physicals Medical Clinic Emergency Room 69