Blog, Electronics and Specialization

A Review of CDRH’s Electronic Submission Process

FDA Law Blog

SEPTEMBER 14, 2022

Mullen — As promised in our posts from earlier this summer ( here and here ), we are back to report on our assessment of CDRH’s electronic submission process through its Customer Collaboration Portal (CCP). Say goodbye to your thumb drives and CDs – the CCP electronic submission process couldn’t be easier.

Electronics

Electronics Specialization IT Medical

Electronic 510(k) Submissions Ahead (FINALLY!)

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.

Electronics

Electronics Individual Specialization Physicals

Sponsors May Now Request Access to the CCP for Filing of Device Premarket Submissions Electronically

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 ).

Electronics

Electronics Utilities Specialization IT

4 Ways Temporary Medical Staff Maintain Patient Care

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.

Medical Staff

Medical Staff Medical Patients Healthcare

How Doctors Should Address Lifestyle Creep

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.

Finance

Finance Insurance IT Individual

You don’t need X-Rays in a child with bronchiolitis, croup, asthma, or first time wheezing

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.

Asthma

Asthma Electronics Utilities Clinical Practice

Be The Market: How Doctors Should Invest Their Money

The Motivated MD

OCTOBER 10, 2024

The Three Fund Portfolio This is where we ultimately return to an investment strategy I have written about previously on this blog. I am not liable for any loss of profit or any other commercial damages, including but not limited to special, incidental, consequential, or other damages.

Finance

Finance Individual Management IT

I Finally Matched and I'm Going to be a Plastic Surgeon!!!!

Aspiring Minority Doctor

MARCH 26, 2021

I'm finally ready to share a bit of my testimony, so read on if you'd like to know how God worked everything out in my favor :) If you've been following my blog, then you already know I was reapplying this year, but didn't want to share any details until after Match Day.

IT

IT Family Families Electronics

Clinical Trials Join the Remote Work Revolution: FDA’s New Draft Guidance on Decentralized Clinical Trials

FDA Law Blog

MAY 4, 2023

This draft guidance builds on recommendations that FDA initially developed early in 2020, in response to the COVID-19 challenges (see our blog post on these recommendations here ). Investigators should also maintain a task log of all local health care providers who perform trial-related activities.

Clinic

Clinic Telehealth Provider Electronics

Mastering Responses to FDA 510(k) AI Letters: A Strategic Approach

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. Understanding the Traditional 510(k) Review Timeline There are three types of Premarket Notification 510(k)s: Traditional , Special , and Abbreviated. an administrative appeal) under 21 CFR 10.75

Provider

Provider IT Engineering Medical

(Slightly More) Options for cGMP for Combination Products: FDA Describes Alternative or Streamlined Mechanisms for Compliance

FDA Law Blog

SEPTEMBER 26, 2022

FDA published a proposed list on June 13, 2018 (83 FR 27609), which we blogged about here. 211.167 – Special Testing Requirements: Manufacturers may be able to define “batch” based on the drug constituent part rather than the finished combination product for purposes of special testing requirements involving pyrogens and endotoxins.

Manufacturing

Manufacturing Specialization Provider Medical

The Good, Bad, and Ugly side of 510(k)s—HP&M’s Early Experience with the eSTAR Template for 510(k)s

FDA Law Blog

FEBRUARY 28, 2023

FDA announced on October 3, 2022 that the voluntary electronic Submission Template And Resource (eSTAR) templates would be required beginning October 1, 2023, as we blogged about here. Several sections of the eSTAR templates have questions that walk through related guidance documents.

Provider

Provider Electronics IT Complication

Lead, follow or get out of the way

Physician's Practice

JUNE 20, 2025

Reynolds Blog Article Innovative medical practices thrive by embracing change, prioritizing patient care and learning from setbacks to enhance success and satisfaction. This blog will discuss what early adopters do to implement innovative and exciting practices. or less) on an appointment card.

Management

Management Patient-Centered Appointment Patients

New Draft Guidance Provides Detailed (and Burdensome) Recommendations for Chemical Assessments to Support Medical Device Biocompatibility

FDA Law Blog

NOVEMBER 20, 2024

It is recommended to submit a Pre-Submission to the Agency when considering your chemical characterization strategy, especially for any devices/materials with special considerations or use of alternative strategies and solvents. FDA is extending the comment period on the notice published September 20, 2024 ( 89 FR 77162 ).

Provider

Provider Medical Manufacturing Consulting

I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 2)

FDA Law Blog

MAY 20, 2021

Houck — Although we blogged on Drug Enforcement Administration (“DEA”) cyclic and on-site inspections in June 2014, we thought it helpful to update registrants on what they can expect as diversion investigators resume activities following the Covid-19 shutdown. By Larry K.

Management

Management Consulting Provider Physicals

I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 2)

FDA Law Blog

MAY 20, 2021

Although we blogged on Drug Enforcement Administration (“DEA”) cyclic and on-site inspections in June 2014, we thought it helpful to update registrants on what they can expect as diversion investigators resume activities following the Covid-19 shutdown. By Larry K.

Management

Management Consulting Provider Physicals

CMS Finalizes Guidance on Medicare Part D Manufacturer Discount Program

FDA Law Blog

DECEMBER 3, 2023

Manufacturers must also ensure that all electronic FDA listings and all NDC listings with the electronic database vendors used to process pharmacy claims, including information about discontinued drugs, are up to date for all applicable drug and selected drug NDCs.

Manufacturing

Manufacturing Provider IT Electronics

GeriPal 300th Episode: Ask Me Anything Hot Ones Style

GeriPal

FEBRUARY 29, 2024

Anne: Well, speaking of your kids, a very special, sometimes listener, chimed in named Ren Smith. I actually wrote a blog post about this when we were a blog. We were a blog? Why are all these companies after me trying to get my money and get me an electronic wheelchair? I’m sure we all have the same issue.

IT

IT Patient-Centered Illness Education

Sweet! A Metabolic Disorders focused podcast episode

PEMBlog

MARCH 27, 2024

My special guest podcaster, Emily Groopman, is an actual Pediatric Geneticist in training and we hope that you will find this episode useful. So my special guest host on this episode is a trainee in pediatrics and medical genetics. I will take a comment on Facebook or the blog. And you’re thinking, hey! No, I’m not.

Consulting

Consulting Individual Family Families

DEA Cranks Out Updated Special Surveillance List and Proposed Regulatory Actions

FDA Law Blog

JUNE 10, 2025

DEA publishes the Special Surveillance List to inform about potential illicit uses of a laboratory supply and reminds that civil penalties may be imposed on businesses that distribute a laboratory supply with reckless disregard for the illegal uses to which it will be put. DEA published the original Special Surveillance in May 1999.

Specialization

Specialization Manufacturing Electronics PCP

Primary Care Digest

A Review of CDRH’s Electronic Submission Process

Electronic 510(k) Submissions Ahead (FINALLY!)

Trending Sources

Sponsors May Now Request Access to the CCP for Filing of Device Premarket Submissions Electronically

4 Ways Temporary Medical Staff Maintain Patient Care

How Doctors Should Address Lifestyle Creep

You don’t need X-Rays in a child with bronchiolitis, croup, asthma, or first time wheezing

Be The Market: How Doctors Should Invest Their Money

I Finally Matched and I'm Going to be a Plastic Surgeon!!!!

Clinical Trials Join the Remote Work Revolution: FDA’s New Draft Guidance on Decentralized Clinical Trials

Mastering Responses to FDA 510(k) AI Letters: A Strategic Approach

(Slightly More) Options for cGMP for Combination Products: FDA Describes Alternative or Streamlined Mechanisms for Compliance

The Good, Bad, and Ugly side of 510(k)s—HP&M’s Early Experience with the eSTAR Template for 510(k)s

Lead, follow or get out of the way

New Draft Guidance Provides Detailed (and Burdensome) Recommendations for Chemical Assessments to Support Medical Device Biocompatibility

I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 2)

I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 2)

CMS Finalizes Guidance on Medicare Part D Manufacturer Discount Program

GeriPal 300th Episode: Ask Me Anything Hot Ones Style

Sweet! A Metabolic Disorders focused podcast episode

DEA Cranks Out Updated Special Surveillance List and Proposed Regulatory Actions

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