2023, Electronics and Manufacturing

510(k) Modernization 2023

FDA Law

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510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents. Baumhardt, Senior Medical Device Regulation Expert & Adrienne R.

Medical

Medical Electronics Manufacturing Utilities

eMDR System Enhancements

FDA Law

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.

Electronics

Electronics Manufacturing Provider Medical

FDA Issues Draft Guidance on Registration and Listing for Cosmetics Required under MOCRA

FDA Law

AUGUST 13, 2023

Specifically, with some exceptions, parties that own or operate a facility engaged in the manufacturing or processing of a cosmetic product for distribution in the United States must list their facilities. In the case of contract manufacturers, either the contract manufacturer or the person whose name appears on the label (i.e.,

Manufacturing

Manufacturing Electronics IT

Trading Partners May Exhale: FDA Releases Guidance Exercising a Year-Long Period of Enforcement Discretion Related to DSCSA Enforcement of Certain Provisions

FDA Law

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.

Supply Chain

Supply Chain Electronics Manufacturing Provider

As 2024 Closed, FDA Issued a Proposed Rule on Asbestos Testing; Implementation of MoCRA Remains Much Slower Than Planned

FDA Law

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. MoCRA mandates that FDA develop a regulation regarding the testing for asbestos in talc (statutory deadline for proposed rule Dec.

Manufacturing

Manufacturing Electronics

FDA Publishes Final Rule to Amend and Reduce Regulatory Burden on Outdated and Duplicative Requirements as They Pertain to Radiological Health Regulations

FDA Law

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.

Manufacturing

Manufacturing Electronics Medical Provider

Helping FDA Help Itself: Voluntary Submissions of Allegations of Regulatory Misconduct

FDA Law

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 ). Any comments to the public notice must be submitted by August 11, 2023.

Manufacturing

Manufacturing Utilities Electronics IT

As the Calendar Turns, Cybersecurity Remains Key Focus of Digital Health Enforcement

FDA Law

JANUARY 5, 2023

It is another effort from CDRH’s Digital Health Center of Excellence to provide structure and guidance to participants across the connected device playing field, including both delivery organizations as well as manufacturers. Digital providers and manufacturers not only have the concerns of the FDA to consider, but those of the FTC as well.

Manufacturing

Manufacturing Patient-Centered Provider Telehealth

CMS Finalizes Guidance on Medicare Part D Manufacturer Discount Program

FDA Law

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

Manufacturing Provider IT Electronics

FDA Publishes Draft Guidance on Voluntary Malfunction Summary Reporting Program for Medical Devices

FDA Law

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

Medical Manufacturing Individual Provider

Buckle Up: DOJ Initiates Rulemaking to Reschedule Marijuana

FDA Law

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. §

Physicals

Physicals Medical Clinic Emergency Room

DEA Cranks Out Updated Special Surveillance List and Proposed Regulatory Actions

FDA Law

JUNE 10, 2025

Special Surveillance List of Chemicals, Products, Materials and Equipment Used in the Manufacture of Controlled Substances and Listed Chemicals, 90 Fed. We think that the agency will revise and update the list more frequently as clandestine manufacturing trends require. 21 U.S.C. § 21 U.S.C. § 842(a)(11). 23,711 (June 4, 2025).

Specialization

Specialization Manufacturing Electronics PCP

Primary Care Digest

510(k) Modernization 2023

eMDR System Enhancements

Trending Sources

FDA Issues Draft Guidance on Registration and Listing for Cosmetics Required under MOCRA

Trading Partners May Exhale: FDA Releases Guidance Exercising a Year-Long Period of Enforcement Discretion Related to DSCSA Enforcement of Certain Provisions

As 2024 Closed, FDA Issued a Proposed Rule on Asbestos Testing; Implementation of MoCRA Remains Much Slower Than Planned

FDA Publishes Final Rule to Amend and Reduce Regulatory Burden on Outdated and Duplicative Requirements as They Pertain to Radiological Health Regulations

Helping FDA Help Itself: Voluntary Submissions of Allegations of Regulatory Misconduct

As the Calendar Turns, Cybersecurity Remains Key Focus of Digital Health Enforcement

CMS Finalizes Guidance on Medicare Part D Manufacturer Discount Program

FDA Publishes Draft Guidance on Voluntary Malfunction Summary Reporting Program for Medical Devices

Buckle Up: DOJ Initiates Rulemaking to Reschedule Marijuana

DEA Cranks Out Updated Special Surveillance List and Proposed Regulatory Actions

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