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OCTOBER 23, 2020

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Family Medicine

Family Medicine DO Primary Care Patient-Centered

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

FDA Law Blog

FEBRUARY 9, 2024

We previously blogged on the draft guidance ( here ) and on FDA’s broader framework for Digital Health Technologies (DHT) ( here and here ). The final guidance provides additional discussion with respect to DHTs that meet the definition of a device.

Clinic

Clinic Manufacturing Provider Electronics

OTAT Town Hall on Cell Therapy CMC – The Recording is Available but Here’s an Appetizer

FDA Law Blog

JANUARY 4, 2023

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and controls (CMC).

Manufacturing

Manufacturing Engineering Clinic Provider

Mastering Responses to FDA 510(k) AI Letters: A Strategic Approach

FDA Law Blog

JULY 10, 2023

In this blog post, we will first briefly outline the procedural steps in the 510(k) review process for medical devices. However, the strategy of addressing the AI request presented in the next section of this blog post applies to all three types of 510(k)s. FDA Day (in calendar days) FDA Actions Day 1 FDA receives 510(k) submission.

Provider

Provider IT Engineering Medical

So Much More than Just Paperwork – The Importance of Design Controls for Device Start-ups

FDA Law Blog

FEBRUARY 7, 2023

There are many resources that provide information and guidance for each of these required elements. Or, to put it another way: We have not yet met an engineer who enjoys remediating the documents for development work that was done in the past.

Manufacturing

Manufacturing Medical Engineering IT

FDA’s New Draft Guidance on 510(k) Implant Devices: What You Need to Know

FDA Law Blog

OCTOBER 10, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. One of these documents focuses on “ Evidentiary Expectations for 510(k) Implant Devices.”

Manufacturing

Manufacturing Engineering Clinic Patients

FDA Issues Two Guidance Documents on Food Allergen Labeling Requirements

FDA Law Blog

DECEMBER 8, 2022

labeling of major food allergens in bulk foods, dietary supplements, protein-free ingredients, and foods produced through genetic engineering); and. 1, 2023; The applicability of food allergen labeling requirements to specific products (e.g., Other technical labeling matters. 1, 2023, sesame. lampreys); Bony fish (e.g., trout); and.

Engineering

Engineering Transportation Manufacturing Education

BE labeling Rule Challenge Largely Fails but Court Takes Issue with Electronic and Text Message Disclosure Options

FDA Law Blog

SEPTEMBER 29, 2022

Plaintiffs challenged the use of the term bioengineered (rather than GMO or genetically engineered), the limitation of the mandatory disclosure being required only if the food contains detectable modified genetic material and the options of using a QR code disclosure or a text message for the disclosure statement.

Electronics

Electronics Engineering Provider

FDA Issues “Cliffs Notes”-style Guidance on Cell and Gene Therapy; What CMC Questions Did They Answer? (Part 2)

FDA Law Blog

DECEMBER 15, 2024

In eight pages we get a string of high-level regulatory questions that provide a nice roadmap for CMC product development, which largely align with opportunities to engage with CBER as you progress through the development of cellular and gene therapies (CGT). What can be gained from this new guidance from a CMC perspective is more nuanced.

Manufacturing

Manufacturing Engineering Patient-Centered Provider

The New FDA Draft Human Factors Guidance: A Bridge Too Far

FDA Law Blog

FEBRUARY 22, 2023

In 2016 , the agency issued its definitive HF guidance, guide manufacturers through human factors engineering processes during the development of new medical devices, focusing specifically on the user interface.

Manufacturing

Manufacturing Engineering Medical IT

Congratulations to HP&M’s first Principal Medical Device Regulation Expert, Adrienne Lenz

FDA Law Blog

JANUARY 5, 2022

She has also held positions in regulatory affairs, quality assurance, and test engineering at GE Healthcare and Smiths Medical. As a Principal Medical Device Regulation Expert, Adrienne will continue to provide consulting to medical device and combination product manufacturers.

Medical

Medical Consulting Engineering Manufacturing

Congratulations to HP&M’s first Principal Medical Device Regulation Expert, Adrienne Lenz

FDA Law Blog

JANUARY 5, 2022

She has also held positions in regulatory affairs, quality assurance, and test engineering at GE Healthcare and Smiths Medical. As a Principal Medical Device Regulation Expert, Adrienne will continue to provide consulting to medical device and combination product manufacturers.

Medical

Medical Consulting Engineering Manufacturing

Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions

FDA Law Blog

JANUARY 2, 2022

However, where the ASME standard assumes the ability to perform traditional validation activities, the Draft Guidance provides a more general framework that additionally incorporates non-traditional validation evidence. Calculation verification determines the solution accuracy of a calculation.

Medical

Medical Provider Physicals Engineering

HP&M Files Comments Opposing FDA’s Proposed LDT Rule

FDA Law Blog

DECEMBER 6, 2023

Part 11, the need to hire new laboratory personnel, and engage outside experts such as Contract Research Organizations, biostatisticians, lawyers, and software engineers. The PRIA also omits entire other categories of costs, such compliance with 21 C.F.R. Nevertheless, whenever the final rule is issued, there is very likely to be litigation.

Engineering

Engineering Medical Complication Screening

Bathrooms “R” Us

Physician's Practice

JUNE 27, 2025

Reynolds Blog Article The small details, like restroom cleanliness, shape patient perceptions and impact healthcare experiences in practices. This may cause you to question the airline’s attention to details like engine maintenance or losing passenger’s luggage.

Management

Management Private Practice Patients Medical

Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions

FDA Law Blog

JANUARY 2, 2022

However, where the ASME standard assumes the ability to perform traditional validation activities, the Draft Guidance provides a more general framework that additionally incorporates non-traditional validation evidence. Calculation verification determines the solution accuracy of a calculation.

Medical

Medical Provider Physicals Engineering

OTAT Becomes the Office of Therapeutic Products (OTP) and Kicks off Town Hall Series – They appear to be tired of writing the same “Complete Response” Letters

FDA Law Blog

OCTOBER 6, 2022

If developers want to use a surrogate test(s) for function they must comply with product specific considerations, such as whether the test(s) is specific to the product, provides meaningful measure of activity, and contributes to the overall potency assessment. OTP recognized that this strategy may not be possible for all products (e.g.,

Manufacturing

Manufacturing Clinic Engineering Individual

New South Family Medicine and MedSpa Offers Next Level Care

New South Family Medicine and MedSpa

NOVEMBER 24, 2022

Direct primary care offers you and your family top-notch health care, and so much more.like a high patient and provider satisfaction with an improved quality of care. Providers at New South Family Medicine and MedSpa can address the patient's deeper needs, rather than trying to rush through a hectic day full of too-brief appointments.

Family Medicine

Family Medicine DO Family Families

Anatomy of a Healthy Plate- Guest Blogger Rebecca Gray

New South Family Medicine and MedSpa

SEPTEMBER 17, 2019

Eating fruit provides excellent health benefits and is part of a healthy plate. Fruits provide nutrients vital for health and maintenance of your body. Fiber containing foods such as fruits help provide a feeling of fullness with fewer calories. Folate (folic acid) helps the body form red blood cells.

Referral

Referral Family Medicine DO Primary Care

Do You Hear What I Hear? One Year of OTC Hearing Aids

FDA Law Blog

NOVEMBER 8, 2023

The rule also aimed to provide “consumers with perceived mild to moderate hearing loss with improved access to devices that meet their needs and are less expensive than current options.” That rule went into effect on October 17, 2022, leading us to this blog post about the one-year anniversary. Access has expanded.

Utilities

Utilities IT Engineering Appointment

Gone in a Puff of Smoke? FDA’s Proposed Rule on Maximum Nicotine Levels

FDA Law Blog

FEBRUARY 5, 2025

FDA provided various ways that the nicotine reduction can be achieved, including tobacco blending, chemical extraction, genetic engineering, and different farming methods. The proposed rule would also impose additional requirements on tobacco manufacturers, such as using a manufacturing code and recordkeeping.

Manufacturing

Manufacturing Engineering Electronics IT

Primary Care Digest

Welcome Dr. Ruffo

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

Trending Sources

OTAT Town Hall on Cell Therapy CMC – The Recording is Available but Here’s an Appetizer

Mastering Responses to FDA 510(k) AI Letters: A Strategic Approach

So Much More than Just Paperwork – The Importance of Design Controls for Device Start-ups

FDA’s New Draft Guidance on 510(k) Implant Devices: What You Need to Know

FDA Issues Two Guidance Documents on Food Allergen Labeling Requirements

BE labeling Rule Challenge Largely Fails but Court Takes Issue with Electronic and Text Message Disclosure Options

FDA Issues “Cliffs Notes”-style Guidance on Cell and Gene Therapy; What CMC Questions Did They Answer? (Part 2)

The New FDA Draft Human Factors Guidance: A Bridge Too Far

Congratulations to HP&M’s first Principal Medical Device Regulation Expert, Adrienne Lenz

Congratulations to HP&M’s first Principal Medical Device Regulation Expert, Adrienne Lenz

Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions

HP&M Files Comments Opposing FDA’s Proposed LDT Rule

Bathrooms “R” Us

Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions

OTAT Becomes the Office of Therapeutic Products (OTP) and Kicks off Town Hall Series – They appear to be tired of writing the same “Complete Response” Letters

New South Family Medicine and MedSpa Offers Next Level Care

Anatomy of a Healthy Plate- Guest Blogger Rebecca Gray

Do You Hear What I Hear? One Year of OTC Hearing Aids

Gone in a Puff of Smoke? FDA’s Proposed Rule on Maximum Nicotine Levels

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