FDA Law Blog

JANUARY 14, 2025

29, 2023), a regulation for fragrance allergen labeling (statutory deadline for proposed rule June 29, 2024); and good manufacturing practice regulations (statutory deadline for proposed rule Dec. If FDA meets those deadlines, 2025 will be a busy year for both FDA and industry. Just on the cusp of 2024, on Dec.

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FDA Law Blog

SEPTEMBER 22, 2024

MDR FDA discussed a few preliminary steps that it says laboratories should take prepare for submitting MDRs as medical device manufacturers. SCG : Modified version of another manufacturer’s FDA-authorized test within scope described in preamble to LDT Final Rule. SCH : LDT, approved by NYS CLEP. It should be noted that 21 CFR 803.18(b)(1)(ii)

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FDA Law Blog

DECEMBER 3, 2023

As part of this change, the Coverage Gap Discount Program (CGDP), a program that has existed since 2011, will sunset on December 31, 2024, and be replaced by the Medicare Part D Manufacturer Discount Program (the “Discount Program”). CMS will send the final manufacturer invoice for discount liabilities accrued by then on April 30, 2028.

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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

JUNE 10, 2025

Special Surveillance List of Chemicals, Products, Materials and Equipment Used in the Manufacture of Controlled Substances and Listed Chemicals, 90 Fed. 23,711 (June 4, 2025). We think that the agency will revise and update the list more frequently as clandestine manufacturing trends require. 23,483 (June 3, 2025).

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FDA Law Blog

FEBRUARY 5, 2025

Clissold During the final week of the Biden administration, on January 15, 2025, FDA issued a proposed rule that, if finalized, would establish a maximum nicotine level in cigarettes and other combusted tobacco products, including most cigars and pipes, through its authority under Section 907 of the FD&C Act to adopt tobacco product standards.

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