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.

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FDA Law Blog

FEBRUARY 7, 2023

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. It will generally be easier to generate these documents contemporaneously with device development as part of a structured procedure, rather than doing so afterwards.

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Manufacturing Medical Engineering IT 98

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By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program.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

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FDA Law Blog

NOVEMBER 5, 2023

During this time, he deftly led multi-disciplinary teams, comprised of engineers, scientists, and clinicians, in the review of intricate submissions that left an indelible mark on the industry.

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Engineering Specialization Community Medical 52

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.

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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.

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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. Prior to joining HP&M, Adrienne worked as an independent regulatory consultant and consultant with Emergo.

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Medical Consulting Engineering Manufacturing 40

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. Prior to joining HP&M, Adrienne worked as an independent regulatory consultant and consultant with Emergo.

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Medical Consulting Engineering Manufacturing 40

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.

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Manufacturing Engineering Patient-Centered Provider 52

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.

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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.

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FDA Law Blog

OCTOBER 6, 2022

rare diseases) and recommended developers either leverage data they have from similar products they’ve manufactured from pre-clinical lots, engineering lots, and small-scale development studies, or to design the manufacturing process to allow for more drug product to be used during the clinical study.

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FDA Law Blog

JANUARY 2, 2022

We are interested to hear from engineers as to whether this guidance will also prove helpful in developing and validating CM&S. As FDA indicates, it is especially important to consider these issues within the clinical context (conditions of use). A model that is credible in one context may not be credible in another.

Medical 52

Medical Provider Physicals Engineering 52

FDA Law Blog

JANUARY 2, 2022

We are interested to hear from engineers as to whether this guidance will also prove helpful in developing and validating CM&S. As FDA indicates, it is especially important to consider these issues within the clinical context (conditions of use). A model that is credible in one context may not be credible in another.

Medical 40

Medical Provider Physicals Engineering 40

New South Family Medicine and MedSpa

NOVEMBER 24, 2022

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DO Family Medicine Family Families 40

New South Family Medicine and MedSpa

SEPTEMBER 17, 2019

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FDA Law Blog

SEPTEMBER 16, 2022

The Executive Order also mentions the need to develop genetic engineering technologies and techniques and advance the science of scale-up production so that innovative technologies and products can reach markets faster. We’ve only touched on a few of the objectives identified in this ambitious and all-encompassing order.

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FDA Law Blog

NOVEMBER 8, 2023

For those who are unfamiliar with the rule, let us briefly explore its history across three different administrations (see our previous blogs: here , here , and here ). That rule went into effect on October 17, 2022, leading us to this blog post about the one-year anniversary. In some measurable ways, the rule has been a success.

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Utilities IT Engineering Appointment 64

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.

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Manufacturing Engineering Electronics IT 66