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OCTOBER 23, 2020

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Family Medicine

Family Medicine DO Primary Care Patient-Centered

Gentlemen, Start Your Engines: DEA’s Marijuana Rescheduling Hearing Begins Monday

FDA Law Blog

NOVEMBER 26, 2024

The NPRM was consistent with the Department of Health and Human Services’ finding that marijuana has a currently accepted medical use in the U.S. Schedules of Controlled Substances: Rescheduling of Marijuana, 89 Fed. 44,597 (May 21, 2024). and its views about abuse potential and physical or psychological dependence.

Engineering

Engineering Physicals IT 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

Clinic Manufacturing Provider Electronics

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

FDA Law Blog

FEBRUARY 7, 2023

Lenz, Principal Medical Device Regulation Expert — For medical device start-up companies, understanding and successfully navigating applicable FDA regulations and requirements is an important part of the path to market. Part 830), post-market surveillance studies (Section 522 of the FD&C Act), medical device tracking (21 C.F.R.

Manufacturing

Manufacturing Medical Engineering IT

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

FDA Law Blog

JANUARY 5, 2022

Lenz has become its first Principal Medical Device Regulation Expert. She has also held positions in regulatory affairs, quality assurance, and test engineering at GE Healthcare and Smiths Medical. Hyman, Phelps & McNamara, P.C. (HP&M) HP&M) is pleased to announce Adrienne R. Adrienne joined HPM in September 2017.

Medical

Medical Consulting Engineering Manufacturing

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

FDA Law Blog

JANUARY 5, 2022

Lenz has become its first Principal Medical Device Regulation Expert. She has also held positions in regulatory affairs, quality assurance, and test engineering at GE Healthcare and Smiths Medical. Hyman, Phelps & McNamara, P.C. (HP&M) HP&M) is pleased to announce Adrienne R. Adrienne joined HPM in September 2017.

Medical

Medical Consulting Engineering Manufacturing

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

FDA Law Blog

JANUARY 2, 2022

Lenz, Principal Medical Device Regulation Expert — On December 23, 2021, CDRH released as a draft guidance, Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions (Draft Guidance). Draft Guidance at 5. A model that is credible in one context may not be credible in another.

Medical

Medical Provider Physicals Engineering

HP&M Welcomes Senior FDA Official, Ana Loloei, to the Firm

FDA Law Blog

FEBRUARY 19, 2024

Loloei tackled legal matters related to various aspects of the regulation of medical devices, in vitro diagnostics, and combination products including regulatory and compliance issues, dispute resolutions between the FDA and sponsors, and FDA enforcement actions. During her FDA tenure, Ms. Gibbs , HP&M Director.

Engineering

Engineering Manufacturing Specialization Management

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

FDA Law Blog

JANUARY 2, 2022

Lenz, Principal Medical Device Regulation Expert — On December 23, 2021, CDRH released as a draft guidance, Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions (Draft Guidance). Draft Guidance at 5. A model that is credible in one context may not be credible in another.

Medical

Medical Provider Physicals Engineering

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

FDA Law Blog

JULY 10, 2023

Lenz, Principal Medical Device Regulation Expert — It takes a significant amount of time, cost, and effort to prepare a premarket notification 510(k) submission. In this blog post, we will first briefly outline the procedural steps in the 510(k) review process for medical devices. By Philip Won & Adrienne R.

Provider

Provider IT Engineering Medical

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. Now FDA has issued a draft guidance , Content of Human Factors Information in Medical Device Marketing Submissions (Dec.

Manufacturing

Manufacturing Engineering Medical IT

14th Asia Pacific Symposium on Cochlear Implant and Related Sciences Set to Convene in Seoul — Featuring HP&M’s Dr. Philip Won

FDA Law Blog

NOVEMBER 5, 2023

Dr. Won will share his expertise and insights on the intricacies of the United States Food and Drug Administration (FDA) regulations pertaining to medical devices, with a special focus on class II and class III hearing devices. Philip Won , of Hyman, Phelps & McNamara, P.C.

Engineering

Engineering Specialization Community Medical

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

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

FDA Law Blog

DECEMBER 6, 2023

FDA tries to justify the proposed rule by claiming that LDTs present significant risks, and that the solution is to regulate them all as medical devices. Part 11, the need to hire new laboratory personnel, and engage outside experts such as Contract Research Organizations, biostatisticians, lawyers, and software engineers.

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. A clean bathroom goes unnoticed because it’s expected. But a dirty one?

Management

Management Private Practice Patients Medical

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

For tissue-engineered medical products, examples may include biomechanical testing to assess the ability of a vascular graft to tolerate repeat access without leaking, permeability testing to assess the characteristics of a skin graft, or cellular distribution throughout a cell scaffold construct.

Manufacturing

Manufacturing Engineering Patient-Centered Provider

New South Family Medicine and MedSpa Offers Next Level Care

New South Family Medicine and MedSpa

NOVEMBER 24, 2022

You can continue to use your insurance for medications and for labs as well. However, with DPC you can find discounts on medications, labs, imaging, and supplements that are passed on to you. blog":{"type":"Static","pageId":"tomo1"},"./medspa-policies":{"type":"Static","pageId":"c8gi2"},"./event-list":{"type":"Static","pageId":"lmi71"},"./general-clean":{"type":"Static","pageId":"u6anc"},".

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

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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 established a new category of OTC hearing aids for individuals with mild to moderate hearing loss, allowing them to purchase hearing aids directly from stores or online retailers without the need for a medical examination, prescription, or fitting adjustment by an audiologist. In some measurable ways, the rule has been a success.

Utilities

Utilities IT Engineering Appointment

Primary Care Digest

Welcome Dr. Ruffo

Gentlemen, Start Your Engines: DEA’s Marijuana Rescheduling Hearing Begins Monday

Trending Sources

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

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

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 Welcomes Senior FDA Official, Ana Loloei, to the Firm

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

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

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

14th Asia Pacific Symposium on Cochlear Implant and Related Sciences Set to Convene in Seoul — Featuring HP&M’s Dr. Philip Won

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

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

Bathrooms “R” Us

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

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

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