Electronics Information Manufacturing Physicals 
FDA Law Blog
AUGUST 10, 2023
Cato — On August 3rd, FDA issued 11 warning letters to foreign facilities registered as OTC drug manufacturers. FDA has resumed on-site inspections of foreign facilities focused on current Good Manufacturing Practices (cGMP) but has continued issuing records requests under Section 704(a)(4), which spurred this latest round of warning letters.
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
MARCH 20, 2022
Almost all recalls are conducted on a voluntary basis by the manufacturer. FDA maintains a database for recalls of FDA-regulated products based on information gathered from press releases and other public notices. “It It is critical for firms in a product distribution chain to be “recall ready.””.
FDA Law Blog
MAY 20, 2021
The investigators ask the registrant’s designated responsible employee, such as the Operations or Compliance Manager, for informed consent by signing a Notice of Inspection (“DEA Form-82”). Registrants should consult with counsel and their Human Resources departments in deciding whether to provide this information.
FDA Law Blog
MAY 20, 2021
The investigators ask the registrant’s designated responsible employee, such as the Operations or Compliance Manager, for informed consent by signing a Notice of Inspection (“DEA Form-82”). Registrants should consult with counsel and their Human Resources departments in deciding whether to provide this information.
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.
FDA Law Blog
MAY 21, 2024
and its abuse may lead to only moderate or low physical dependence or high psychological dependence. Public comments must be submitted electronically or postmarked on or before July 22, 2024, 60 days after publication in the Federal Register. 21 U.S.C. § 21 U.S.C. § Basis at 61; NPRM at 44,615. at 44,617, 44,619. Basis at 64-65.
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