Electronics, Information, Manufacturing and Medical

Is my Software a Medical Device? Use the Digital Health Policy Navigator

FDA Law Blog

DECEMBER 12, 2022

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert & Lisa M. Baumhardt, Senior Medical Device Regulation Expert — With the explosion of health‑related software, many software developers are generating products with functionality that is subject to regulation by the Food and Drug Administration (FDA).

Medical

Medical Manufacturing Electronics Provider

The Future Of Vision And Eye Care

The Medical Futurist

JUNE 21, 2025

Compared to that, our hearing only processes 11 percent of information, while smell 3.5 However, things are moving fast, and success doesn’t come easy for the pioneers of any medical field. percent, touch 1.5 percent and taste 1 percent. Don’t you think that’s possible? Renowned scholars, L.D.

Diabetes

Diabetes Patient-Centered IT Patients

eMDR System Enhancements

FDA Law Blog

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 Releases Final Guidance on Use of Digital Health Technologies for Remote Data Acquisition in Clinical Investigations

FDA Law Blog

FEBRUARY 9, 2024

Lenz, Principal Medical Device Regulation Expert & Lisa M. Baumhardt, Senior Medical Device Regulation Expert — As an end of the year gift, FDA finalized its guidance document, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations , in late December. By Adrienne R.

Clinic

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New Draft Guidance Provides Detailed (and Burdensome) Recommendations for Chemical Assessments to Support Medical Device Biocompatibility

FDA Law Blog

NOVEMBER 20, 2024

Chemical characterization identifies and quantifies chemicals that may be released from the medical device, while a toxicological risk analysis (TRA) evaluates the risks to the patient associated with the chemicals identified. Chemical characterization can also be useful in evaluating a change to the materials or manufacturing of a device.

Provider

Provider Medical Manufacturing Consulting

FDA Hosts Webinar for Stage 1 Requirements under LDT Final Rule

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. By Steven J. Gonzalez & Lisa M.

Manufacturing

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

FDA Law Blog

JUNE 27, 2023

By Véronique Li, Senior Medical Device Regulation Expert & Anne K. 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 ). This statistic is quite disheartening.

Manufacturing

Manufacturing Utilities Electronics IT

(Slightly More) Options for cGMP for Combination Products: FDA Describes Alternative or Streamlined Mechanisms for Compliance

FDA Law Blog

SEPTEMBER 26, 2022

Lenz, Principal Medical Device Regulation Expert & Holly N. requires generally that manufacturing of a combination product (CP) must comply with the applicable current Good Manufacturing Practice regulations (cGMPs) for all of its components ( i.e., a drug/device CP must follow the cGMPs for drugs as well as those for medical devices).

Manufacturing

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Are You Recall Ready? FDA Expects You to Be

FDA Law Blog

MARCH 20, 2022

Baumhardt, Senior Medical Device Regulation Expert & Anne K. 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 By Philip Won & Lisa M.

Electronics

Electronics Manufacturing Provider IT

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

FDA Law Blog

DECEMBER 18, 2022

Mullen — On December 9, 2022, FDA issued a draft guidance document on the Voluntary Malfunction Summary Reporting (VMSR) Program for medical devices. The VMSR Program allows manufacturers to bundle malfunction reports of “like events” together in a single summary report. In that letter, FDA stated that it would “permit manufacturers.

Medical

Medical Manufacturing Individual Provider

Less than Meets the Eye: LDT Small Entity Compliance Guide Adds Little Insight

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. §

Manufacturing

Manufacturing Provider Physicals Electronics

Cannabis Advocates High On Recent Medical Marijuana Research Legislation

FDA Law Blog

JANUARY 8, 2023

The enactment of the Medical Marijuana and Cannabidiol Research Expansion Act (“the Act”) into law (Public Law 117-215) last month is a step in that direction. To date 39 states and the District of Columbia have legalized cannabis for medical use (and 21 for adult recreational use), mainly through ballot initiatives. 21 U.S.C. §

Medical

Medical Manufacturing Electronics Provider

Buckle Up: DOJ Initiates Rulemaking to Reschedule Marijuana

FDA Law Blog

MAY 21, 2024

The 2016 reviews concluded that marijuana continued to meet schedule I criteria for having a high potential for abuse, no currently accepted medical use in treatment in the U.S., and lacked accepted safety for use under medical supervision. Currently Accepted Medical Use in Treatment in the U.S. 21 U.S.C. § 21 U.S.C. §

Physicals

Physicals Medical Clinic Emergency Room

DEA Cranks Out Updated Special Surveillance List and Proposed Regulatory Actions

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).

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Primary Care Digest

Is my Software a Medical Device? Use the Digital Health Policy Navigator

The Future Of Vision And Eye Care

Trending Sources

eMDR System Enhancements

FDA Releases Final Guidance on Use of Digital Health Technologies for Remote Data Acquisition in Clinical Investigations

New Draft Guidance Provides Detailed (and Burdensome) Recommendations for Chemical Assessments to Support Medical Device Biocompatibility

FDA Hosts Webinar for Stage 1 Requirements under LDT Final Rule

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

(Slightly More) Options for cGMP for Combination Products: FDA Describes Alternative or Streamlined Mechanisms for Compliance

Are You Recall Ready? FDA Expects You to Be

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

Less than Meets the Eye: LDT Small Entity Compliance Guide Adds Little Insight

Cannabis Advocates High On Recent Medical Marijuana Research Legislation

Buckle Up: DOJ Initiates Rulemaking to Reschedule Marijuana

DEA Cranks Out Updated Special Surveillance List and Proposed Regulatory Actions

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