FDA Law Blog

JULY 12, 2022

Mullen — Last month, FDA announced two important steps towards accepting electronic 510(k) submissions. As discussed in an earlier post ( here ), CDRH piloted the eSTAR electronic submission template last year. Being able to submit completely electronically would be a huge benefit in terms of efficiency and timing for applicants.

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FDA Law Blog

JULY 31, 2022

Mullen — On July 19, 2022, CDRH announced to users of its Customer Collaborations Portal (CCP) that it is now accepting premarket submissions electronically. As previously noted, this is very exciting news for the device industry, which up to this point has had to continue to ship electronic media to CDRH each time a submission is filed.

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FDA Law Blog

NOVEMBER 29, 2021

Currently, DEA regulations do not address transfer of controlled substance prescriptions — whether paper or electronic — between pharmacies for the initial filling of the prescription. As with other DEA recordkeeping requirements, the electronic record must be maintained for two years. The proposed rule also just makes sense.

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FDA Law Blog

SEPTEMBER 29, 2022

As readers may recall, the current regulation provides for four options for a disclosure statement, i.e., text disclosure, symbol disclosure, electronic disclosure (QR code with a phone number for further information), and a text message disclosure.

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FDA Law Blog

OCTOBER 5, 2022

The development of an electronic submission template for 510(k) submissions is significant in that: eSTAR submissions are not expected to go through the refuse to accept (RTA) process. Exemptions from the electronic submission requirements apply to interactive review responses and some amendments (e.g., add-to-files).

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FDA Law Blog

AUGUST 9, 2023

However, electronic prescriptions for controlled substances (“EPCS”), which a practitioner transmits directly to a pharmacy, do not allow the patient such an option. Transfer of Electronic Prescriptions for Schedule II-V Controlled Substances Between Pharmacies for Initial Filling, 88 Fed. 48365, 48369 (July 27, 2023).

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Family Medicine Initiative

APRIL 9, 2024

million electronic health records in the USA showed a lower risk for suicidal thoughts in those taking semaglutide than in those taking other weight loss medications. In March 2024, this was supported by a large Scandinavian cohort study which followed 145,410 patients over four years and found no increased risk of thyroid cancer.

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FDA Law Blog

OCTOBER 5, 2022

Now, according to the Center’s announcement, anyone may request access to the CCP and begin filing premarket submissions electronically. On October 3, 2022, CDRH announced the expansion of this program. CDRH’s website provides a link to request access to the CCP ( here ).

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FDA Law Blog

DECEMBER 12, 2022

This blog post describes the medical device determination process and a way of assessing software functions to determine if your software product is subject to FDA regulations. Step 4: Is the software function intended to serve as electronic patient records? Likely FDA intends to exercise enforcement discretion.

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Physician's Practice

JUNE 23, 2025

Reynolds Fact checked by Chris Mazzolini Blog Article Navigating the health tech landscape requires strategic diligence to avoid hidden costs and ensure seamless integration in medical practices. The health technology gold rush is back on, and sales reps know where to find you.

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FDA Law Blog

JULY 31, 2023

Practitioner’s Partial Fill Request A practitioner issuing a schedule II prescription who wants it to be partially filled must specify the quantity to be dispensed in each partial filling on the face of a written prescription, in the written record of an emergency oral prescription, or in the record of an electronic prescription. b)(5)(i)).

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Dr. Zaar

MAY 20, 2025

In this blog, we’ll answer the most common questions and explain why more people are choosing online hormonal therapy services across Canada. You will get hold of prescriptions electronically, and And observe-up visits manifest thru video or smartphone calls. What Is Hormonal Therapy?

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FDA Law Blog

JULY 20, 2021

As readers of our blog know, “Product of USA” and other country of origin labeling issues on meat and poultry products have been an issue of discussion in recent years. or the Egg Products Inspection Act.

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Barton Associates

MAY 8, 2025

In this blog, we’re going to outline four key ways temporary medical staff such as locum tenens providers can help healthcare facilities maintain continuity of high-quality patient care in the face of growing shortages. Adapt quickly to new processes, electronic health record (EHR) systems, and more.

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FDA Law Blog

AUGUST 26, 2024

Interested persons can file electronically as a PDF attachment via email to the Drug Enforcement Administration, Attn: Administrator at nprm@dea.gov or in writing to the Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, VA 22152 within 30 days after publication in the Federal Register.

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FDA Law Blog

AUGUST 8, 2023

This second half of this guidance beginning with the “Flowchart to Predict the Carcinogenic Potency Category of an NDSRI and Identify an Associated Recommended AI Limit” takes one back to basic organic chemistry and breaks down the key structural and electronic considerations into a step-by-step guide.

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FDA Law Blog

MARCH 8, 2023

By Véronique Li, Senior Medical Device Regulation Expert — On March 17, 2023, enhancements to FDA’s electronic Medical Device Reporting (eMDR) system will go live. Manufacturers who submit reports via the FDA Electronic Submissions Gateway are being advised to update their systems by this time.

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FDA Law Blog

SEPTEMBER 11, 2023

The electronic Submission Template and Resource (eSTAR) program, which we blogged about here and here , also makes the highlight reel given its aim to improve consistency and efficiency in how 510(k)s are prepared. Over the years, we’ve blogged on similar initiatives related to the 510(k) pathway.

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FDA Law Blog

FEBRUARY 9, 2024

We previously blogged on the draft guidance ( here ) and on FDA’s broader framework for Digital Health Technologies (DHT) ( here and here ). However, in general, FDA does not intend to request machine or raw data that require electronic processing to be understood in an inspection.

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FDA Law Blog

OCTOBER 24, 2023

Mullen — As of October 1, 2023, all 510(k) submissions, unless exempted, must be submitted to FDA using the electronic Submission Template And Resource ( eSTAR ). On September 29, 2023, FDA released a draft guidance on Electronic Submission Template for Medical Device De Novo Requests.

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FDA Law Blog

NOVEMBER 9, 2021

Lenz, Senior Medical Device Regulation Expert — FDA introduced electronic copies (eCopies) of 510(k)s in 2013 (see our prior blogs here and here ) as a way to reduce the need for submission of paper copies of 510(k)s to the Agency. This pilot program, which utilized FDA’s eSubmitter electronic submission template, ended in May 2021.

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FDA Law Blog

SEPTEMBER 22, 2024

See our prior blog post summarizing the different phaseout stages and categories of enforcement discretion. After a lab submits an MDR, FDA said that laboratories should save the electronic “Acknowledgement 3” (Ack3) generated after submitting an MDR in the MDR event files. It should be noted that 21 CFR 803.18(b)(1)(ii)

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Noreta Family Medicine

JUNE 25, 2024

While some medical offices have changed to electronic forms, many still require that you put pencil to paper. Now, I want to be clear that by writing this blog, I am not saying that health insurance companies are evil! Similar to Kyle’s experience, the more offices you go to, the more forms you need to fill out.

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The Clinical Problem Solvers

SEPTEMBER 28, 2019

Much has changed in the clinical work environment since these master clinicians were in training – work hour restrictions, the internet, electronic medical records, and the increasing medical complexity of our patients, just to name a few.

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FDA Law Blog

JUNE 27, 2023

Walsh — Last fall, we blogged about the process FDA uses to review allegations of regulatory misconduct against device manufacturers, suggesting greater transparency on the FDA process was needed (see here ). As we discussed in our prior blog post, there needs to be a better way to understand the outcome of FDA’s review.

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FDA Law Blog

JUNE 10, 2024

Establishments using electronic information systems to hold, analyze, process or transfer pertinent information should be prepared to provide FDA access to such systems. Ensure all relevant records and data (whether electronic or otherwise) are readily accessible and organized for review.

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FDA Law Blog

OCTOBER 18, 2022

By Véronique Li, Senior Medical Device Regulation Expert & Philip Won — Last week, our blog post advised planning a transition strategy in advance of the news of the termination of the Covid-19 public health emergency. electronic thermometers, single lumen needles, piston syringes).

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FDA Law Blog

MARCH 7, 2024

The new draft guidance is generally reflective of these developments, and we wanted to highlight several of the changes in this blog post. Both documents also note that FDA may request copies of the DMC meeting records when the study is completed, and access to the electronic data sets used for each set of interim analysis.

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FDA Law Blog

APRIL 19, 2022

Houck — Effective May 11, 2022, the Drug Enforcement Administration (“DEA”) will require all applications and renewals for registration to be submitted electronically. By Larry K. DEA will not accept bank checks for the foreseeable future. Renewal Applications are available here.

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FDA Law Blog

AUGUST 13, 2023

FDA is developing an electronic portal for registration and listing submissions that will be available in October 2023. On the same day that FDA issued the draft guidance, the Agency issued a request for (nine) volunteers to participate in a pilot program on the electronic registration and listing program.

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FDA Law Blog

JANUARY 30, 2025

Second, while the exceptional circumstances safety valve appears in the section of the statute regarding FOIA requests, there is no corresponding language in the section stating that an agency shall make available for public inspection in an electronic format certain records.

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The Motivated MD

DECEMBER 18, 2024

I am using our weekly blog posts to create a future book that hopefully will apply to medical trainees and early career physicians looking to build generational wealth, get out of debt, and take control of their financial lives. Infuse your budget, buy a new electronic, place it in cryptocurrency, whatever.

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FDA Law Blog

AUGUST 27, 2023

The compliance policies described in the Guidance focus on the requirement that, beginning November 27, 2023, all trading partners generally will be required to use electronic-based approaches to meet the enhanced drug distribution security requirements set forth in in FDCA section 582(g)(1) (Enhanced Drug Distribution Security).

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FDA Law Blog

APRIL 20, 2021

Remove non-device software functions intended for storing and retrieving, so that a medical image storage device is a hardware device that provides electronic storage and retrieval functions for medical images. By McKenzie E. Certain types of clinical decision-support software. Medical Image Storage Device. 892.2050.

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PEMBlog

AUGUST 30, 2023

This is a blog post and a podcast episode designed to disseminate the important work of Choosing Wisely , an initiative of the the American Board of Internal Medicine Foundation, the goal of which is the spark conversations between clinicians and patients about what tests, treatments, and procedures are needed – and which ones are not.

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FDA Law Blog

APRIL 19, 2023

Reminders of the need to fulfill existing environmental assessment requirements and make all submissions electronically are also included. Now FDA has made it clear that submissions are expected to be in English, electronically searchable, of reasonable size font, generally on 8.5

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FDA Law Blog

JULY 28, 2021

Registrants may also use DEA’s electronic Controlled Substance Ordering System (“CSOS”)). Electronic comments must be submitted, and written comments postmarked, on or before August 19, 2021. Official Order Form for Schedule I and II Controlled Substances (DEA Form 222) , 84 Fed. 51368 (Sept. 21 C.F.R § 1305.12(c).

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