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)

Manufacturing 64

Manufacturing Electronics Provider Management 64

FDA Law Blog

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 ). Supporting information is critical to illustrate the specific points of regulatory misconduct.

Manufacturing 59

Manufacturing Utilities Electronics IT 59

FDA Law Blog

APRIL 25, 2024

This Revised Draft Guidance provides considerations for manufacturers, packers or distributors (dubbed “firms”) of prescription biological reference products, biosimilar products, and interchangeable biosimilar products presenting data and information about such products in promotional materials in a truthful and non-misleading way.

Provider 59

Provider Electronics Manufacturing IT 59

FDA Law Blog

NOVEMBER 20, 2024

Chemical characterization can also be useful in evaluating a change to the materials or manufacturing of a device. The draft guidance provides recommendations for collection and reporting of chemical characterization data and discusses the topics of information gathering, test article extraction, chemical analysis, and data reporting.

Provider 59

Provider Medical Manufacturing Consulting 59

FDA Law Blog

SEPTEMBER 26, 2022

Brevig, Senior Regulatory Device and Biologics Exper — FDA recently published Alternative or Streamlined Mechanisms for Complying with the Current Good Manufacturing Practice Requirements for Combination Products; List under the 21st Century Cures Act in the Federal Register (FR Notice). By way of background, 21 C.F.R. § 21 C.F.R. §

Manufacturing 40

Manufacturing Specialization Provider Medical 40

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.””.

Electronics 40

Electronics Manufacturing Provider IT 40

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. Section #1: FDA Interactions Given the wide range of sponsors (i.e.,

Clinic 59

Clinic Provider IT Electronics 59

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.

Management 40

Management Consulting Provider Physicals 40

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.

Management 40

Management Consulting Provider Physicals 40

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.

Manufacturing 105

Manufacturing Provider IT Electronics 105

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.

Manufacturing 64

Manufacturing Provider Physicals Electronics 64

FDA Law Blog

DECEMBER 18, 2022

Generally, FDA’s MDR regulations require device manufacturers to submit Medical Device Reports (MDRs) for individual reportable malfunctions within 30 calendar days of the manufacturer becoming aware of the malfunction. In that letter, FDA stated that it would “permit manufacturers.

Medical 59

Medical Manufacturing Individual Provider 59

FDA Law Blog

JANUARY 8, 2023

The Act mandates that DEA streamline and accelerate registration application procedures for cannabis researchers and manufacturers of cannabis for research. With respect to timing, DEA must issue a registration or request supplemental information within 60 days after receiving a complete application. Cannabis Researcher Registrations.

Medical 64

Medical Manufacturing Electronics Provider 64

FDA Law Blog

NOVEMBER 22, 2022

In an effort to correct some of the bottlenecks in traceability efforts, the final rule imposes additional recordkeeping requirements on domestic and foreign firms who manufacture, process, pack, or hold foods on the Food Traceability List (FTL) for U.S. Following an update, the previous traceability plan must be retained for two years.

Supply Chain 52

Supply Chain Illness Family Families 52

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. For each factor, the NPRM noted that DEA’s position is that additional information during the rulemaking will further inform about the appropriate schedule for marijuana. 21 U.S.C. §

Physicals 69

Physicals Medical Clinic Emergency Room 69

FDA Law Blog

JUNE 10, 2025

DEA publishes the Special Surveillance List to inform about potential illicit uses of a laboratory supply and reminds that civil penalties may be imposed on businesses that distribute a laboratory supply with reckless disregard for the illegal uses to which it will be put. 21 U.S.C. § 21 U.S.C. § 842(a)(11). 23,711 (June 4, 2025).

Specialization 69

Specialization Manufacturing Electronics PCP 69