FDA Law Blog

MAY 29, 2025

Based on our experience with FDA review of 510(k) applications, a single document may be updated several times over the course of the review, and a document submitted in response to an FDA information request may completely replace a previously submitted document.

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FDA Law Blog

MAY 8, 2023

The discussion paper described a PCCP as including (1) the types of anticipated modifications (SaMD Pre-Specifications or SPS) based on the retraining and model update strategy and (2) the associated methodology (Algorithm Change Protocol or ACP) being used to implement those changes in a controlled manner to manage patient risks.

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FDA Law Blog

DECEMBER 12, 2022

If you are a manufacturer of implants that go into the human body for the treatment of disease, it’s an easy yes that you are a manufacturer of a medical device. It identifies key questions to consider that originate from a variety of FDA guidance documents and aggregates the information into a one-stop shop.

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Medical Manufacturing Electronics Provider 23

CDOCS

AUGUST 11, 2021

.</span></p> <p><span style="font-size:14px;">This patient presented with a chief complaint of his poorly matching crown on tooth #9. This crown has been in service for 10 years, but now the patient would like to replace it for his daughters upcoming wedding (figure 1). .</span></p>

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CDOCS

FEBRUARY 14, 2025

These files can be stored alongside other patient records, shared with colleagues, or included in lab orders for streamlined collaboration.& </strong> now allows users to upload bridge case designs to DS Core, enabling centralized management of end-to-end manufacturing tasks. .&

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Management Manufacturing Patients Specialization 52

FDA Law Blog

FEBRUARY 28, 2022

Bauer, Senior Regulatory Drug Expert — Our readers probably know that we value and advocate for patient engagement as an essential component in the development of medical products (see our firm’s commitment here ).

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FDA Law Blog

JANUARY 18, 2022

Cato — On December 10, 2021, FDA issued a discussion paper titled 3D Printing Medical Devices at the Point of Care seeking feedback on FDA regulatory oversight of various 3D-printing scenarios, in order to inform future policy development. Specifically, that it allows for fast production of “patient-matched devices” (i.e.,

Medical 75

Medical Manufacturing Healthcare Government 75

CDOCS

JANUARY 12, 2021

It saves dentists time and money while attracting patients and adding valuable services.</p> They currently leverage inLab design software and SprintRay to create as many same-day opportunities for their patients as possible. </p> <p>Drs.

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Manufacturing Utilities Patients IT 52

FDA Law Blog

DECEMBER 12, 2022

Shapiro — Last summer, FDA published a draft guidance, Laser-Assisted In Situ Keratomileusis (LASIK) Lasers – Patient Labeling Recommendations (July 29, 2022) setting forth a proposal for new recommended patient‑directed labeling. The approved devices already have patient‑directed labeling that FDA has approved. By Jeffrey K.

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Manufacturing Provider Patients IT 52

FDA Law Blog

JUNE 2, 2025

Those in the lab industry and the physicians and patients who rely upon LDTs are sure to be breathing a well-deserved sigh of relief over this development. Just before this decisive event, though, FDA released a relatively rare Warning Letter to a manufacturer of research use only (RUO) reagents.

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IT Manufacturing Government Clinic 64

FDA Law Blog

APRIL 2, 2024

And though FDA may not have gotten everything that it wanted last year, reviewing and reflecting on these lists of legislative proposals provides important insight for industry to see where FDA thinks it might need congressional assistance to “better support Agency efforts to protect American consumers and patients.”

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FDA Law Blog

MARCH 8, 2023

Manufacturers who submit reports via the FDA Electronic Submissions Gateway are being advised to update their systems by this time. Since the final rule took effect on August 14, 2015, medical device manufacturers and importers have been required to submit MDRs in an electronic format.

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FDA Law Blog

NOVEMBER 30, 2022

According to the allegations in the complaint, approval of the new Los Angeles manufacturing facility required a Prior Approval Supplement (PAS) and a Pre-Approval Inspection (PAI) of the facility. 3729) quit tam suit, alleging that Grifols USA, Grifols Biologicals, Grifols, S.A.,

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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).

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Manufacturing Engineering Clinic Provider 59

CDOCS

MAY 4, 2021

Without this additional skill set and post graduate training I simply could not deliver the results that my patients deserve. & A healthy 46-year-old patient who has lived for over 30 years with missing bilateral maxillary incisors desired a fixed solution to his problem.

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Patient-Centered Patients Manufacturing Clinic 52

FDA Law Blog

JUNE 16, 2023

Kirschenbaum — On May 24, Minnesota enacted the Commerce and Consumer Protection Omnibus Bill, Senate File 2744 ( SF 2744 ), which significantly expands the state’s existing drug pricing activities with serious implications for all drug manufacturers, and particularly generic drug manufacturers. We address each below. Best price?

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FDA Law Blog

AUGUST 27, 2023

The Guidance specifically states that it is issuing the Guidance – applicable to trading partners including manufacturers, distributors, dispensers, and repackagers – to address industry “readiness” to comply with the DSCSA’s provisions. Drug manufacturers have had electronic systems in place since 2017. Guidance at 4.

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Supply Chain Electronics Manufacturing Provider 52

FDA Law Blog

SEPTEMBER 22, 2024

MDR FDA discussed a few preliminary steps that it says laboratories should take prepare for submitting MDRs as medical device manufacturers. SCG : Modified version of another manufacturer’s FDA-authorized test within scope described in preamble to LDT Final Rule. is it the lab itself, the healthcare provider, or the patient?).

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Manufacturing Electronics Provider Management 64

FDA Law Blog

OCTOBER 10, 2023

Performance data should be customized to the indications for use, including the specific intended patient population (adult vs. pediatric), disease state, conditions of use, and the target anatomical location. In cases where devices are expected to be frequently replaced, testing should be guided by the aggregate patient exposure.

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FDA Law Blog

NOVEMBER 20, 2024

Chemical characterization identifies and quantifies chemicals that may be released from the medical device, while a toxicological risk analysis (TRA) evaluates the risks to the patient associated with the chemicals identified. Chemical characterization can also be useful in evaluating a change to the materials or manufacturing of a device.

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FDA Law Blog

SEPTEMBER 29, 2021

The 340B program, authorized under Section 340B of the Public Health Services Act and administered by HRSA, imposes a ceiling price on pharmaceutical manufacturer sales to “covered entities,” which are certain health clinics that receive federal funding and certain types of safety net hospitals to provide them drugs at lower prices.

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Physician's Practice

JUNE 9, 2025

a health care attorney and practice group manager with Roetzel & Andress, joins the show to break down the hidden legal risks of prescribing GLP-1 medications that physicians need to know about, from ensuring informed consent to navigating long-term safety data. 68: Hidden risks of prescribing GLP-1 drugs with Ericka L. Adler, J.D.,

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Management Telemedicine Patients Insurance 52

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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Manufacturing Engineering Medical IT 64

FDA Law Blog

MARCH 1, 2023

The purpose of these two pilot programs was initially to inform development of a FDA rating system to characterize the QMM of a facility. FDA describes the QMM as “above-the-bar behaviors” that exceed good manufacturing practices (GMPs). FDA staff served as pilot program observers, but also met with the contractors to provide feedback.

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FDA Law Blog

NOVEMBER 7, 2021

We reported that HRSA was proceeding with enforcement actions against drug manufacturers that have declined to sell to 340B covered entities that use multiple contract pharmacies to dispense 340B drugs to their patients, despite the pendency of several lawsuits challenging such enforcement. Last week, the U.S.

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Manufacturing IT Provider Patients 52

FDA Law Blog

SEPTEMBER 6, 2022

Below we outline the Draft Guidance and highlight the new information in the 2022 Draft Guidance. For this last question, FDA explains that it anticipates the sponsor would charge the patient directly or would charge a payor if reimbursement were available, but clearly states that FDA has no authority in this arena.

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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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IT Patient-Centered Patients Clinic 120

FDA Law Blog

OCTOBER 10, 2022

The final guidance therefore may have significant implications for a wide range of stakeholders, including not only software developers but also health care providers, hospitals, patients and payors. Criterion 2 : Non-Device CDS software functions display, analyze or print medical information about a patient or other medical information.

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Clinic Medical Provider Patients 52

FDA Law Blog

SEPTEMBER 15, 2022

FDA indicates that this guidance is intended to help manufacturers ensure consistent content and format of the statement of identity and strength for all nonprescription drug products, which then will allow consumers to compare products. For both draft guidances, it is unclear what induced FDA to publish these draft guidances now.

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CDOCS

SEPTEMBER 29, 2021

<p><span style="font-size:12px;"><em>Mike Skramstad, DDS</em></span><br /> <em>Sponsored by Dentsply Sirona</em></p> <p><span style="font-size:14px;">This patient presented with a RCT tooth that previously had a PFM crown.&

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FDA Law Blog

MARCH 6, 2024

More information about the conference can be found here. His practice supports clients throughout the life sciences from biotech startups and multinational pharmaceutical companies to CROs and academic researchers to patient advocacy organizations. For complete information on the conference, click here.

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Management Manufacturing Government Specialization 59

FDA Law Blog

SEPTEMBER 20, 2021

From new initiatives to facilitate faster reviews for new indications under the Split Real Time Application Review (STAR) pilot program, to bringing new meetings under PDUFA goals, to continued support for rare diseases and incorporation of the patient voice, the goals letter revealed a good number of welcome announcements.

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Patient-Centered Manufacturing Clinic Provider 52

FDA Law Blog

MARCH 31, 2024

The proposed rule extends far beyond the scope of any legislative proposals and would threaten access to reliable tests for children and patients with rare diseases.” He emphasized that FDA regulatory oversight should focus on those tests that pose the highest risk to patients. These are areas where “revenue is modest,” she said.

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FDA Law Blog

MAY 3, 2021

The CSA establishes a closed system of controlled substance distribution that requires every entity in the chain, from importers to manufacturers, distributors, exporters, pharmacies, hospitals, narcotic treatment programs and practitioners, to obtain a DEA registration and account for the controlled substances they handle. 21 U.S.C. §

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FDA Law Blog

SEPTEMBER 21, 2022

The monkeypox test policy describes how FDA will prioritize review of EUA requests for monkeypox tests, stating that FDA intends to focus on requests for high-throughput tests, tests with home specimen collection, or rapid diagnostic tests, all from experienced developers with high manufacturing capacity.

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FDA Law Blog

OCTOBER 14, 2021

Food and Drug Administration (FDA) is reminding patients and health care providers that the safety and effectiveness of robotically-assisted surgical (RAS) devices for use in mastectomy procedures or in the prevention or treatment of breast cancer have not been established. These clearances are based on short-term (30 day) patient follow up.

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Patient-Centered Healthcare Manufacturing Provider 52

FDA Law Blog

APRIL 14, 2021

Ask and ye shall receive, if yer requests are vocal and repeated, and ye are patient, and willing to accept less than ye ask for. For more than a year we have been asking FDA to initiate virtual or remote inspections of drug manufacturing facilities. business days,” the same deadline set for responding to a Form 483.

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