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Lenz, Principal Medical Device Regulation Expert — On December 23, 2021, CDRH released as a draft guidance, Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions (Draft Guidance). Draft Guidance at 5. Calculation verification determines the solution accuracy of a calculation.

Medical 40

Medical Provider Physicals Engineering 40

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 Now FDA has issued a draft guidance , Content of Human Factors Information in Medical Device Marketing Submissions (Dec.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 64

Manufacturing Engineering Medical IT 64

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By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program.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 45

Manufacturing Engineering Clinic Patients 45

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 52

Manufacturing Engineering Patient-Centered Provider 52

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 59

Engineering Medical Complication Screening 59

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 52

Management Private Practice Patients Medical 52

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 40

Family Medicine DO Family Families 40

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 40

Referral Family Medicine DO Primary Care 40

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 64

Utilities IT Engineering Appointment 64