FDA Law Blog

NOVEMBER 29, 2023

Guiding Principle 10 focused on monitoring the performance of the models and managing re-training risks. Five guiding principles were identified for PCCPs and relate to being focused, risk-based, evidence-based, transparent, and taking into consideration total product lifecycle management.

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FDA Law Blog

MAY 29, 2025

Lenz, Principal Medical Device Regulation Expert & Lisa M. Baumhardt, Principal Medical Device Regulatory Expert & Gail H. As we recently blogged about here and here , FDA has issued guidance on lifecycle management for AI-enabled device software functions. By Adrienne R.

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FDA Law Blog

MARCH 6, 2023

By Véronique Li, Senior Medical Device Regulation Expert — A year ago, we blogged about a proposed rule that would replace the Quality System Regulation (QSR) at 21 C.F.R. Part 820 with a newly named Quality Management System Regulation (QMSR) (see here ).

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Minnesota Academy of Family Physicians

MARCH 27, 2025

As we move into the tenth week of the legislative session, Minnesota Academy of Family Physicians (MAFP) lobbyist Megan Verdeja breaks down what’s happening at the Minnesota State Capitol and provides an update on health care bills. 1878 ( Representative Keeler ) would cover traditional health care practices under Medical Assistance.

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My Green Doctor

MAY 3, 2025

In This Issue : Why Renewable Energy Belongs in Every Clinic Medical Waste: One Model for Improvement OnTrack with your Sustainability Goals? Our Consulting Services offer customized strategies for group practices, health systems, and medical societies ready to accelerate their impact and lead the way in climate-smart care.

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FDA Law Blog

MAY 8, 2023

Baumhardt, Senior Medical Device Regulation Expert & Philip Won & Gail H. In February 2020, FDA granted a de novo classification request (DEN190040) for software intended to assist medical professionals in the acquisition of cardiac ultrasound images and that included a PCCP for future software modifications.

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FDA Law Blog

APRIL 25, 2023

Shapiro — Does your firm manufacture a “cyber device”? Congress has given FDA the authority to require device manufacturers to provide cybersecurity information in their premarket submissions for a “cyber device.” Software as a Medical Device, or SaMD) or the software is embedded in a traditional hardware device (i.e.,

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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 807), establishing a quality management system (QMS) (21 C.F.R. By Adrienne R. Design controls (21 C.F.R.

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FDA Law Blog

FEBRUARY 13, 2025

Baumhardt, Principal Medical Device Regulatory Expert FDA recently released its final guidance for Predetermined Change Control Plans (PCCPs) for Artificial Intelligence-Enabled Device Software Functions (AI-DSF). FDA recommends including only a limited number of modifications in the PCCP.

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FDA Law Blog

MAY 3, 2021

Maintaining complete and accurate records with direct, ongoing oversight by management reduces risk of internal employee pilferage and maximizes potential for early detection should diversion occur. Part 1 provides background and explains the scope of DEA cyclic and on-site inspections. 21 U.S.C. §

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FDA Law Blog

SEPTEMBER 22, 2024

Instead, we focus here on the few notable statements that provide new or more detailed guidance than FDA has previously offered. MDR FDA discussed a few preliminary steps that it says laboratories should take prepare for submitting MDRs as medical device manufacturers. By Steven J. Gonzalez & Lisa M.

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FDA Law Blog

MAY 27, 2024

(HPM) proudly announces the return of Jennifer Newberger as a Director, further boosting its already robust medical device practice. Jennifer’s combination of experiences as in-house counsel for both large and start-up companies as well as outside counsel provides clients invaluable expertise and problem-solving skills.

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FDA Law Blog

MARCH 6, 2022

Part 820, with a newly named Quality Management System Regulation (QMSR). The QMSR omits many of the specific QSR requirements that currently appear in the regulations, and instead incorporates by reference an international standard for medical device quality management systems.

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FDA Law Blog

MAY 3, 2021

Maintaining complete and accurate records with direct, ongoing oversight by management reduces risk of internal employee pilferage and maximizes potential for early detection should diversion occur. Part 1 provides background and explains the scope of DEA cyclic and on-site inspections. 21 U.S.C. §

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FDA Law Blog

OCTOBER 31, 2022

Lenz, Principal Medical Device Regulation Expert — FDA began the Software Precertification (Pre-Cert) pilot program in 2017 to evaluate an alternative approach to regulation of software as a medical device (SaMD) over the total product lifecycle (TPLC). By Adrienne R. Key Performance Indicators.

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FDA Law Blog

NOVEMBER 16, 2021

Baumhardt , MS, MJ, MT(ASCP), RAC, FRAPS, has joined the firm as a Senior Medical Device Regulation Expert, and that Sophia Gaulkin has joined the firm as an Associate. Baumhardt provides counsel to medical device, in vitro diagnostic, and combination product manufacturers on a wide range of pre- and post-marketing regulatory topics.

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FDA Law Blog

MAY 31, 2021

One of these amendments was a poorly thought-out rule that, if implemented, will render virtually unusable the current best price exclusion for manufacturer patient savings programs in the form of coupons, patient rebates/refunds, copay assistance, vouchers, and free drug programs. The effective date of this amendment is January 1, 2023.

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FDA Law Blog

JUNE 5, 2023

By Dara Katcher Levy — The Academy of Managed Care Pharmacy (AMCP)’s Format Executive Committee is excited to let you know that after two years of work, version 5.0 Please review the proposed revisions to the Format and provide your comments in this form by June 30. And we need your feedback!

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FDA Law Blog

JUNE 5, 2025

The Office of Management, which was eliminated in the April 1 RIF, was responsible for processing these requests, and generally did so within 60 days of receipt. We note that the webpage for the Office of Management is still functional, but has not been updated since January 2024.)

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

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Physician's Practice

JUNE 9, 2025

a health care attorney with Roetzel & Andress, joins the show to explore the legal risks of prescribing GLP-1 medications. Conclusion and Closing Remarks (00:25:02)** Thanking the guest, closing the episode, and providing subscription information. 68: Hidden risks of prescribing GLP-1 drugs with Ericka L. Adler, J.D.,

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FDA Law Blog

DECEMBER 16, 2024

Lenz, Principal Medical Device Regulation Expert FDA recently released 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review which finalizes the draft guidance of the same title issued in December 2023. By Adrienne R. FDA), and to generate data in a format that would streamline FDAs review.

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FDA Law Blog

APRIL 11, 2022

Shapiro — One of the more complex areas of device regulation is the management of risks associated with malfunctions reported from the field. Medtronic Warning Letter) provides an important reminder from FDA as to the correct estimation of risk associated with malfunctions. By Jeffrey K.

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FDA Law Blog

SEPTEMBER 26, 2022

Lenz, Principal Medical Device Regulation Expert & Holly N. requires generally that manufacturing of a combination product (CP) must comply with the applicable current Good Manufacturing Practice regulations (cGMPs) for all of its components ( i.e., a drug/device CP must follow the cGMPs for drugs as well as those for medical devices).

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FDA Law Blog

FEBRUARY 5, 2024

HP&M has been helping clients navigate the challenges of state licensing regulations for drugs, biologics, medical devices, OTCs, 503B outsourcing facilities, 503A pharmacies, foods, dietary supplements, cannabis, and wholesalers/distributors for many years.

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FDA Law Blog

OCTOBER 9, 2023

The ACA sets an annual cap on the amount that insurers can require insured individuals to pay out of pocket for their medical expenses. Once an individual reaches this annual cap, the insurer is solely responsible for covering the individual’s remaining medical expenses that year. We previously blogged about this lawsuit last year.

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GeriPal

JUNE 20, 2024

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

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CDOCS

MAY 4, 2021

Couple this with the in-office technologies of CEREC&reg; Primescan and CBCT allowed us to gain control of the technical processes necessary to manage and produce the surgical and restorative phases of treatment at one location.</span></p>

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Patient-Centered Patients Manufacturing Clinic 52

FDA Law Blog

OCTOBER 10, 2022

The CDS Guidance interprets the “medical software” carve-out of the 21st Century Cures Act (2016) as it pertains to Clinical Decision Support (CDS) software functions. The CDS Guidance interprets the Cures Act’s definition of “medical software” that is excluded from the statutory “device” definition, as it relates to CDS software.

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FDA Law Blog

JANUARY 5, 2025

In response to the proposed rule, approximately 200 comments were submitted to the docket, and a meeting took place among FDA, the White House Office of Management and Budget (OMB) and the Consumer Healthcare Products Association (CHPA). The third was the postmarketing requirement for reporting an ACNU failure.

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FDA Law Blog

AUGUST 7, 2023

By Véronique Li, Senior Medical Device Regulation Expert — The Center for Devices and Radiological Health (CDRH) offers learning opportunities for new and experienced CDRH staff through the Experiential Learning Program (ELP). One noticeable difference from years past is the option for virtual site visits.

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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. We find that this information is noteworthy for manufacturers to consider.

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FDA Law Blog

DECEMBER 11, 2023

6] It is inconsistent to say that LDTs must be regulated as medical devices because of the newness of the tests and then reduce the cost of the proposed regulation by declaring that half of all LDTs will be exempt from premarket review. That seems very unlikely to be the case, because exemptions apply only to well-established tests.

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FDA Law Blog

SEPTEMBER 20, 2021

FDA will discuss the goals letter and field public comments, on September 28, 2021 (announcement here ), as well as a separate workshop on meetings management practices, which is to be held by July 30, 2024. Pandemic influences aside, the FY 2023-2027 goals letter contained many notable new initiatives, announcements, and commitments.

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FDA Law Blog

MARCH 20, 2022

Baumhardt, Senior Medical Device Regulation Expert & Anne K. To clarify what preparations companies should take to more seamlessly manage a recall, on March 2, 2022, FDA published its Final Guidance Document on Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C. By Philip Won & Lisa M. Product coding (e.g.,

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FDA Law Blog

MAY 19, 2023

Baumhardt, Senior Medical Device Regulation Expert & Richard A. Final Release Criteria Special Controls Sponsors will need to provide the final manufacturing release criterion with evidence that lots released at the extremes of the specification will still meet the claimed device performance (i.e.,

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FDA Law Blog

MARCH 6, 2025

Lenz, Principal Medical Device Regulation Expert & Lisa M. Both guidance documents recommend data management practices for collecting data for use in developing, tuning, and testing an artificial intelligence model and making changes to said model. By Adrienne R.

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