Blog, Diagnosis and Manufacturing

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

FDA Law

DECEMBER 12, 2022

If you are a manufacturer of implants that go into the human body for the treatment of disease, it’s an easy yes that you are a manufacturer of a medical device. or other similar or related article” which is “intended for use in the diagnosis of disease or other conditions.” The flowchart can be downloaded here.

Medical

Medical Manufacturing Electronics Provider

Proposed LDT Rule Raises Many Questions but Provides Few Answers

FDA Law

OCTOBER 6, 2023

There is much to unpack, and we intend to do so in a series of blog posts. The crux of the proposed rule lies in the addition of ten words: “ including when the manufacturer of these products is a laboratory.” . Future blog posts will analyze FDA’s legal authority as well as FDA’s claimed public health need for LDT regulation.

Provider

Provider Manufacturing IT Medical

FDA Redux? CDRH Policy and EUA Templates for Monkeypox Tests Following Public Health Emergency Declaration Mirror FDA’s COVID-19 Approach

FDA Law

SEPTEMBER 21, 2022

This led to delays in releasing a uniform policy and templates for COVID-19, as well as many other problems (see blog post chronicling some of the challenges here ). We note that this policy defines an “experienced developer” more narrowly than the COVID-19 policy.

Manufacturing

Manufacturing Diagnose Diagnosis IT

Out At Home: FDA’s Vocal Support of Home Testing but Reluctance to Clear Novel OTC Home Tests

FDA Law

JUNE 22, 2023

As a result, novel IVD manufacturers are more likely to start with clearance of a prescription test intended for use in clinical settings with the thought that one day in the future, after several years of clinical experience demonstrating safe use, they may return to FDA to seek clearance of an OTC version.

Manufacturing

Manufacturing Clinic IT Transportation

Ninth Circuit Upholds FDA’s Authority to Regulate Stem Cell Clinic Treatments

FDA Law

OCTOBER 14, 2024

Note we do not discuss the cell expansion variety of this treatment further in this blog as the court quickly dispensed of it as obviously not subject to the SSP exception.) These procedures are offered to treat a variety of conditions, including Alzheimer’s, arthritis, asthma, cancer, etc., 21 U.S.C. §

Clinic

Clinic Patient-Centered Asthma Patients

COVID At-Home Antigen Tests: If at First You Don’t Succeed Try, Try and Try Again

FDA Law

AUGUST 23, 2022

These practical benefits are in marked contrast to molecular COVID-19 tests that are used for definitive diagnosis and are generally expected to detect the SARS-CoV-2 virus at least 95% of the time when someone is infected.

Individual

Individual Clinic Healthcare Provider

Knock, Knock. Who’s There? Breakthrough Device. Breakthrough Device Who? Breakthrough Device That Can’t Get to Market

FDA Law

SEPTEMBER 26, 2024

In particular, CDRH touts its Breakthrough Devices Program, which it advertises as a “program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The reality, however, is quite different.

Clinic

Clinic IT Manufacturing Medical

It Takes Three [Components] to Make a Thing Go Riiiiiight – OPDP Challenges Two-Part Ad

FDA Law

JANUARY 26, 2022

By Dara Katcher Levy — We are working to keep up with OPDP’s posts over the past few weeks and a blog on its most recent letter to Lilly is forthcoming! With apologies to Rob Base and DJ EZ Rock , it took more than “two” to get this Emgality DTC TV commercial right (insert snare drum here please).

IT

IT Education Utilities Patient-Centered

Where Are All the OTC Rapid Antigen Tests for COVID? FDA’s Role in Blocking These Tests from the American Market

FDA Law

NOVEMBER 18, 2021

Rapid tests for COVID-19 are fast, inexpensive to manufacture, and a relatively easy method to detect the presence of an active SARS?CoV?2 PCR) test is considered the gold standard for actual diagnosis. counter (OTC) rapid antigen tests for COVID are widespread and available at low cost. Why is that? Background. 2 infection.

Screening

Screening Healthcare Manufacturing IT

CMS Final Medicaid Drug Rebate Rule Details New Misclassification Penalties and Numerous Other Changes

FDA Law

SEPTEMBER 30, 2024

CMS did not finalize the price verification survey, which would have required manufacturers of 10 costly drugs selected annually to provide clinical information as well as information on production, distribution, research, and marketing costs, revenue and profit, and ex-U.S. Remarkably, manufacturers may not dispute a CMS notification.

Manufacturing

Manufacturing Utilities Provider IT

New Breakthrough Devices Program Guidance: Expanding Opportunities for Medical Product Innovations

FDA Law

OCTOBER 17, 2023

In October 2022, FDA released the draft guidance entitled “Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Healthcare,” as previously discussed in our blog. FDA recognizes the existence of barriers that may hinder underserved populations from receiving medical treatment or diagnosis.

Medical

Medical Diagnosis Healthcare Clinic

CMS Publishes Grab Bag of Proposed Changes to the Medicaid Drug Rebate Program

FDA Law

JUNE 2, 2023

Most are new or revised definitions and administrative changes, but several proposals represent new policies that should be of concern to drug manufacturers. Price Transparency Surveys The MDRP statute requires manufacturers to submit only three prices: average manufacturer price (AMP), best price, and nominal prices.

Manufacturing

Manufacturing Vaccination Government Diagnosis

Joint Basis for FDA/HHS Marijuana Rescheduling Recommendation Unveiled

FDA Law

JANUARY 18, 2024

whether growing or not; its seeds; resin extracted from any part; and every compound, manufacture, salt, derivative, mixture, or preparation of the plant, its seeds or resin. “Marijuana,” subject to the rescheduling recommendation, means all parts of the plant Cannabis sativa L., 21 U.S.C. § 802(16)(A). 21 U.S.C. § 802(16)(B).

Medical

Medical Physicals IT Healthcare Professional

Primary Care Digest

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

Proposed LDT Rule Raises Many Questions but Provides Few Answers

Trending Sources

FDA Redux? CDRH Policy and EUA Templates for Monkeypox Tests Following Public Health Emergency Declaration Mirror FDA’s COVID-19 Approach

Out At Home: FDA’s Vocal Support of Home Testing but Reluctance to Clear Novel OTC Home Tests

Ninth Circuit Upholds FDA’s Authority to Regulate Stem Cell Clinic Treatments

COVID At-Home Antigen Tests: If at First You Don’t Succeed Try, Try and Try Again

Knock, Knock. Who’s There? Breakthrough Device. Breakthrough Device Who? Breakthrough Device That Can’t Get to Market

It Takes Three [Components] to Make a Thing Go Riiiiiight – OPDP Challenges Two-Part Ad

Where Are All the OTC Rapid Antigen Tests for COVID? FDA’s Role in Blocking These Tests from the American Market

CMS Final Medicaid Drug Rebate Rule Details New Misclassification Penalties and Numerous Other Changes

New Breakthrough Devices Program Guidance: Expanding Opportunities for Medical Product Innovations

CMS Publishes Grab Bag of Proposed Changes to the Medicaid Drug Rebate Program

Joint Basis for FDA/HHS Marijuana Rescheduling Recommendation Unveiled

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