submissions Archives

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submissions

Mar

Q-Submission Program

March 24, 2024Ginny GattingerNews

Guidance Update: FDA revises Guidance Document: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program The FDA released a revised draft of the Guidance Document: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program on 15 March, 2024. When finalized, this guidance will supersede both the current version of...

Mar

Some observations from the 2024 AAMI/FDA neXus conference

March 6, 2024Mike RussellBlog

I (Mike Russell) attended the neXus conference on medical device standards this year. Below are some observations and suggested takeaways from the talks I heard and the panel I was on. Remember, these are just selected highlights, not everything said 🙂 Session: Reducing Submission Rejections and Recalls with Software Standards This year’s conference added a third...

Sep

“You can pay me now, or you can pay me later”

September 17, 2023Mike RussellBlog

By Ron Baerg and Mike Russell “You can pay me now, or you can pay me later” was the punch line of a memorable TV commercial by the FRAM® company about their oil filters around 50 years ago. The “me”: a car mechanic. Their point: paying (a little) now to replace your oil filter regularly...

Sep

Software Design Specifications

September 9, 2023Brian PateBlog

What does the US FDA expect in a premarket submission for description of the software design? In the recent June 2023 Guidance for Industry and Food and Drug Administration Staff titled, “Content of Premarket Submissions for Device Software Functions,” the FDA gives the following guidance. For lower risk devices, the manufacturer is not required to...

Jul

Former Employee Forges FDA Clearance Letters

July 26, 2023Brian PateNews

A former employee forges FDA clearance letters at a Philadelphia-area medical device manufacturer. Peter Stoll III pleaded guilty to one felony count of violating the Federal Food, Drug, and Cosmetic Act (FDCA) by causing the introduction of misbranded and adulterated medical devices into interstate commerce, in violation of 21 United States Code, Section 331(a) and 331(a)(2). ...

Mar

Effectively Communicating to FDA

March 23, 2023John MurrayBlog

Effectively Communicating to FDA – being able to appropriately articulate what your software function is intended to do or intended to provide is – the foundation – the corner stone – the linchpin to navigating the correct path, investing your resource wisely, and defending your decisions now and into the future. Solid foundations lead to solid futures....

Oct

FDA Guidance on AI Requests

October 26, 2022Amy SellersNews

FDA releases Guidance on AI requests. To aid manufacturers and reviewers, this guidance emphasizes the “Least Burdensome Provisions” when responding to deficiencies in a regulatory submission. Download the final guidance: 2022-guidance-responding-deficencies-least-burdensome As stated by FDA, this guidance is “intended to help FDA staff develop, and industry respond to, a request for additional information needed to make a...

Apr

Taiwan FDA online Pre-market Application Platform

April 25, 2022Jordan PateNews

Nov

2021 FDA Draft Software Premarket Submission Guidance

November 3, 2021John MurrayBlog, News

Today, the U.S. Food and Drug Administration (FDA) issued the draft guidance: Content of Premarket Submissions for Device Software Functions. The draft guidance is intended to reflect FDA’s most current thinking on the recommended documentation sponsors should include in premarket submissions for FDA’s evaluation of the safety and effectiveness of device software functions, including both...

Apr

Ginny Kwan Gattinger joins SoftwareCPR as a Partner

April 7, 2021Amy SellersNews

(April 6, 2021)— Ginny Kwan Gattinger has joined Crisis Prevention and Recovery LLC (DBA SoftwareCPR®) as a Partner. Ginny is a regulatory affairs professional specializing in software-based products with over 10 years of experience in the regulated industry including medical devices, pharmaceuticals and biotechnology. Ginny has developed regulatory strategies for a variety of SiMD/SaMD and...

Aug

Reviewing What We Know About LOC in Medical Devices

August 13, 2020Amy SellersBlog

Remember the 2005 guidance document, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices? In 2020 that guidance is as relevant as ever, and it can be useful to review what we know about the FDA’s expectations regarding Level of Concern (LOC) in medical devices. LOC is important if for no...

Jan

How do I know if I have a medical device?

January 16, 2020Brian PateNews

How do I know if my device or my software is a medical device? Watch this helpful video and learn about the 513(g) process as well. SoftwareCPR can help you plan your regulatory strategy and handle your regulatory submissions. We would be delighted to help!

May

FDA Final Guidance Q-Submission Program

May 8, 2019Alan KusinitzBlog

Today FDA issued a final guidance, “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program. Guidance for Industry and Food and Drug Administration Staff Document (May 7, 2019). The FDA’s Q-Submission Program provides submitters an opportunity to have early collaboration and discussions about medical device submissions. In our opinion, early feedback and...

Mar

FDA Exempts Flow Cytometry from 510(k) requirements

March 14, 2019Brian PateNews

US FDA has proposed a new rule to exempt Cytometry instruments used for counting or characterizing cells (a well-understood and mature technology), from premarket notification requirements. Cytometry instruments used for sorting or collecting cells, and instruments that are used as an automated hematology analyzer, or that perform automated differential cell counts, will still require premarket...

Dec

FDA Draft Guidance Prescription POC

December 11, 2018Brian PateNews

FDA issued a draft guidance for prescription POC (Point-of-care) entitled “Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use.” This draft guidance document provides recommendations to industry about the types of information to include in their premarket submissions for blood glucose monitoring systems used for diabetes management in the health care prescription POC settings. This guidance...

Dec

FDA Draft Self-Monitoring OTC Glucose Test Systems

December 11, 2018Alan KusinitzNews

FDA issued a draft guidance entitled “Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use“‘. This draft guidance document provides recommendations to industry about the studies and criteria to include in their premarket submissions for self-monitoring blood glucose test systems used for diabetes management in the home setting. This guidance (similar to the Prescription POC guidance)...

Apr

FDA Draft Guidance Expansion of Abbreviated 510(k)

April 12, 2018Jordan PateNews

FDA issued a draft guidance for comment: Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Contains Nonbinding Recommendations Draft – Not for Implementation Equivalence through Performance Criteria. The outline shows a Section 17 for software information. The outline can be viewed here.

Jul

FDA Pre-designation Draft Guidance

July 19, 2017Alan KusinitzNews

FDA issued a new draft guidance entitled”Draft Guidance for Industry; How To Prepare a Pre-Request for Designation”. This guidance is intended to describe informal interaction with FDA that might lead to a formal Designation request to determine wether a product will be regulator as a device or a drug and some combination thereof. The full...

Dec

FDA New eCOPY for Medical Device Submissions

December 5, 2015Alan KusinitzNews

http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm313794.pdf

Aug

FDA Premarket Exemptions August 2015

August 14, 2015Alan KusinitzNews

/docs/FDApremarketclassificationcodexemptionsAug2015.pdf

Oct

FDA Medical Device eCopy webpage updated

October 19, 2014Alan KusinitzNews

http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/ucm370879.htm

Jul

Final FDA 510(k) Substantial Equivalence Guidance

July 28, 2014Alan KusinitzNews

/docs/FDAEvaluatingSubstantialEquivalenceGuidance0714.pdf

May

FDA Device eSubmission Pilot

May 2, 2014Alan KusinitzNews

http://tinyurl.com/n8f2bpe

Mar

FDA Draft Guidance for Electro-Surgical Devices

March 24, 2014Alan KusinitzNews

http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm383206.htm#s5

Jan

FDA 510(k) Submission Process Timeline/Overview

January 6, 2014Alan KusinitzNews

http://tinyurl.com/nl9v9gv

Jan

FDA Final eCopy Guidance

January 3, 2013Alan KusinitzNews

/Docs/FDAeCopyFinalGuidance123112.pdf

Jan

FDA Revised 510(k) Refuse to Accept Policy

January 3, 2013Alan KusinitzNews

/Docs/FDARefuse2AcceptPolicy4510ks123112.pdf

Jan

FDA eCopies eSubmitter Quick Reference Guide

January 3, 2013Alan KusinitzNews

http://www.fda.gov/downloads/ForIndustry/FDAeSubmitter/UCM319824.pdf

Oct

FDA issues draft revised PMA Clock Guidance

October 18, 2012Alan KusinitzNews

http://1.usa.gov/18aG1Uw

Oct

FDA Revises 510(k) Clock Guidance

October 18, 2012Alan KusinitzNews

http://1.usa.gov/I40H6a

Oct

FDA Device Center draft Submission e-copy guidance

October 17, 2012Alan KusinitzNews

http://1.usa.gov/1hLDNAY

Dec

FDA Software Premarket Submissions

December 26, 2008Jordan PateNews

The key guidance document from FDA regarding the software documentation required in a premarket submissions for FDA including 510(k)s, PMAs, and IDEs is the “Guidance for Industry and FDA Staff Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document issued on: May 11, 2005

Aug

FDA Electronic Submission Gateway

August 8, 2006Alan KusinitzNews

FDA announced in the Federal Register (Docket No. 1992S–0251) a central Gateway/single point of entry for electronic submissions for device, drug and biologic applications. It is referred to as the Electronic Submission Gateway (ESG). The announcement describes three secure options for electronic submissions: “The FDA ESG offers two secure communication options for applicants that have...

IEC 62304 and other emerging standards for Medical Device and HealthIT Software

Our flagship course for preparing regulatory, quality, engineering, operations, and others for the activities and documentation expected for IEC 62304 conformance and for FDA expectations. The goal is to educate on the intent and purpose so that the participants are able to make informed decisions in the future. Focus is not simply what the standard says, but what is meant and discuss examples and approaches one might implement to comply. Special deep discount pricing available to FDA attendees and other regulators.

3-days with group exercises, quizzes, examples, Q&A.

Instructor: Brian Pate

Next public offering: June 24-26, 2025 (Virtual, Live)

For private, in-house courses, please contact us.

Email training@softwarecpr.com for more info.

Being Agile & Yet Compliant (Public)

Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for registration!

Agile principles that align well with medical
Backlog management
Agile risk management
Incremental and iterative software development lifecycle management
Frequent release management
And more!

3 days virtual (Zoom) with group exercises, quizzes, examples, Q&A.

Lead Instructor: Mike Russell

Next public offerings:

See our post titled: 1st Quarter 2025 Agile Compliant Courses Scheduled

Medical Device Cybersecurity (Public or Private)

This course takes a deep dive into the US FDA expectations for cybersecurity activities in the product development process with central focus on the cybersecurity risk analysis process. Overall approach will be tied to relevant standards and FDA guidance documentation. The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 81001-5-1, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies.

2-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Dr Peter Rech, 2nd instructor (optional)

Next public offering: TBD

Q-Submission Program

Some observations from the 2024 AAMI/FDA neXus conference

“You can pay me now, or you can pay me later”

Software Design Specifications

Former Employee Forges FDA Clearance Letters

Effectively Communicating to FDA

FDA Guidance on AI Requests

Taiwan FDA online Pre-market Application Platform

2021 FDA Draft Software Premarket Submission Guidance

Ginny Kwan Gattinger joins SoftwareCPR as a Partner

Reviewing What We Know About LOC in Medical Devices

How do I know if I have a medical device?

FDA Final Guidance Q-Submission Program

FDA Exempts Flow Cytometry from 510(k) requirements

FDA Draft Guidance Prescription POC

FDA Draft Self-Monitoring OTC Glucose Test Systems

FDA Draft Guidance Expansion of Abbreviated 510(k)

FDA Pre-designation Draft Guidance

FDA New eCOPY for Medical Device Submissions

FDA Premarket Exemptions August 2015

FDA Medical Device eCopy webpage updated

Final FDA 510(k) Substantial Equivalence Guidance

FDA Device eSubmission Pilot

FDA Draft Guidance for Electro-Surgical Devices

FDA 510(k) Submission Process Timeline/Overview

FDA Final eCopy Guidance

FDA Revised 510(k) Refuse to Accept Policy

FDA eCopies eSubmitter Quick Reference Guide

FDA issues draft revised PMA Clock Guidance

FDA Revises 510(k) Clock Guidance

FDA Device Center draft Submission e-copy guidance

FDA Software Premarket Submissions

FDA Electronic Submission Gateway

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