finalguidance Archives

Tag

finalguidance

Jun

Final Guidance on Content of Premarket Submissions for Device Software Functions

June 13, 2023Brian PateNews

FDA releases Final Guidance on Content of Premarket Submissions for Device Software Functions. This final guidance provides requirements for the recommended documentation manufacturers should include in premarket submissions for the FDA’s evaluation of the safety and effectiveness of device software functions. The guidance replaces the FDA’s Guidance for the Guidance for the Content of Premarket...

Nov

FDA Updated Software Guidance

November 17, 2022Ginny GattingerBlog

In September 2022, FDA Updated the Software Guidance Policy for Device Software Functions and Mobile Medical Applications. Last revised in September 2019, the policy is intended to clarify FDA’s regulatory oversight on software functions, including those used on mobile platforms and general-purpose computing platforms as well as software in the function or control of a...

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

Software Design Verification

April 20, 2022Joel PateBlog

Trying to understand Software Design Verification … A QA’s takeaway on reading the General Principles of Software Validation for the first time. FDA gives guidance in the General Principles of Software Validation guidance document, but in general: Testing at different levels: units, integrated units, software complete Testing types: negative, combinatorial, fault injection, risk controls challenge, boundary, corner cases, stress,...

Jul

General Principles of Software Validation

July 25, 2021Brian PateBlog, News

One of the most important references in creating a software development lifecycle process to assure software quality is the FDA guidance document, “General Principles of Software Validation.” This guidance document has been around for many years. The current version, 2.0, was released in 2002. To many in the industry, this guidance is simply referred to...

Feb

Safer Technologies Program for Medical Devices

February 1, 2021Amy SellersNews

Devices that do not meet the criteria for the Breakthrough Devices Program may have a new option under the Safer Technologies Program for Medical Devices (STeP). Read our previous post on the the Breakthrough Devices Program here: FDA Breakthrough Devices Program Draft Guidance. SteP is a voluntary program for certain medical devices that are “reasonably...

Sep

FDA Releases Digital Health Guidances

September 26, 2019John MurrayNews

The U.S. Food and Drug Administration released a suite of “Digital Health” guidances. The guidances issued today are a continuation of the Agencies efforts announced as part of the Digital Health Innovation Action Plan and address key provisions of the 21st Century Cures Act. The first guidance announced is Clinical Decision Support Software, a revised...

Oct

FDA Final Guidance: Deciding if a new 510(k) is needed

October 25, 2017Amy SellersNews

The FDA issued a new Final guidance, “Deciding When to Submit a 510(k) for a Change to an Existing Device,” on October 25, 2017. The full guidance is at the link provided. This supersedes the 1997 guidance. Note that FDA simultaneously released a Final guidance for when to submit a new 510(k) for software changes...

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

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 offering: Dec 3, 4, & 5, 2024 – 12:00 pm to 5:00 pm CET

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 onsite with group exercises, quizzes, examples, Q&A.

Instructor: Brian Pate

Next public offering: TBD

Call or email now to schedule a private, in-house class. The fall schedule is filling up!

Email training@softwarecpr.com to request a special pre-registration discount. Limited number of pre-registration coupons.

Registration Link:

TBD

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