By

John Murray
23
Mar

Effectively Communicating to FDA

March 23, 2023
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....
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17
Nov

Understanding Risk with Medical Devices

November 17, 2022
On November 15, 2022, I had the pleasure to log in to a “live” FDA CDRH Industry Basics Seminar on Understanding Risk with Medical Devices.  You can view the workshop at this link: https://fda.yorkcast.com/webcast/Play/4aecf454d2d54039a1d5a6a3001d78c31d I did enjoy the materials presented and I do think the presenters Joseph and Tonya did a great job. I would recommend...
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15
Nov

FDA Updates Cybersecurity Playbook

November 15, 2022
FDA Updates Cybersecurity Playbook for Health Care Organizations The healthcare sector knows how to prepare for and respond to natural disasters. It is less prepared, however, to handle cybersecurity incidents, particularly those involving medical devices.  With healthcare-related cyber incidents growing in size and scope, preparedness before a cyber event takes place with a strong, well-exercised,...
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27
Sep

FDA Software Precertification Pilot Ends

September 27, 2022
In September 2022, the FDA Software Precertification Pilot Ends, or has officially “completed” the Software Precertification (Pre-Cert) Pilot Program.  See: https://www.fda.gov/medical-devices/digital-health-center-excellence/digital-health-software-precertification-pre-cert-pilot-program?utm_medium=email&utm_source=govdelivery The pilot explored innovative approaches to regulatory oversight of medical device software developed by organizations that have demonstrated a robust culture of quality and organizational excellence and who are committed to monitoring real-world performance of...
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13
Sep

New FDA Draft Guidance

September 13, 2022
FDA Issues Draft Guidance on Computer Software Assurance for Production and Quality System Software The U.S. Food and Drug Administration (FDA) issued the new draft guidance: Computer Software Assurance for Production and Quality System Software. Download here: 2022-Guidance-Computer-Software-Assurance This new FDA draft guidance provides recommendations on risk-based assurance activities for computers and automated data processing systems that are...
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03
Nov

2021 FDA Draft Software Premarket Submission Guidance

November 3, 2021,
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...
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29
Oct

FY2022 SW Related Guidance

October 29, 2021,
“From my 25 years at the agency, I completely understand that FDA CDRH guidance development, approval and publication is complex, time-consuming work. I often said it may be compared to threading 1000 needles simultaneously. It requires significant time and energy from many hard-working, dedicated professionals to even reach the first goal of published draft guidance....
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23
Sep

FDA Digital Transformation

September 23, 2021
FDA’s Digital Transformation and the regulation of Medical Device Cybersecurity? I read the recent FDA post that discussed the FDA’s Digital Transformation: “Today, the U.S. Food and Drug Administration announced the reorganization of the agency’s information technology (IT), data management and cybersecurity functions into the new Office of Digital Transformation (ODT).” Then I was reading...
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19
Apr

FDA Modifying Medical Device Classifications

April 19, 2021
The FDA is officially modifying medical device classifications for some software functions. On April 19, 2021, the agency published a “final” rule that updates eight classification regulations by amending these regulations to exclude software functions that no longer fall within the device definition under 201(h) of the FD&C Act. With this final rule, FDA is amending the...
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04
Dec

View draft revisions of FDA guidance?

December 4, 2020
Is it possible to view draft revisions of FDA guidance documents when they are a “work in progress,” or are they only become available once published as draft?  This is a frequent question that I have heard. However, the FDA does not typically provide copies or drafts of “works in progress” for those items that...
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17
Nov

Draft guidance on EMC

November 17, 2020
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance on EMC entitled ‘‘Electromagnetic Compatibility (EMC) of Medical Devices.’’ This new “draft” guidance document is intended to recommend information that should be provided in a premarket submissions to demonstrate electromagnetic compatibility (EMC) for electrically powered medical devices and medical...
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09
Nov

CDRH Proposed Guidance Updates

November 9, 2020
FDA released their CDRH Proposed Guidance Updates that includes a significant amount of “software related” guidance in FY 2021. There are four separate guidance documents listed for publication in FY 2021. IMO that is a fairly large commitment from the agency and I will look forward to reading about the agency’s “current thinking” on these...
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14
Sep

Digital Health pre-cert program update

September 14, 2020
On September 14, 2020 the Digital Health Team at FDA provided a 2020 Update on the Software Precertification Pilot Program. The announcement is a short 8-page document. The document provides the details that are driving program development. It contains a considerable amount of information that may take a few reads to fully understand. On my...
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21
Mar

COVID-19 Public Health Emergency – FDA Telemedicine

March 21, 2020
The US FDA released a new guidance document communicating a new policy intended to expand the use a hospital based vital signs equipment to include home use.  This policy changes is in response to the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.  You can download the guidance by clicking this link: Enforcement Policy for Non-Invasive...
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19
Dec

Looking Forward to Teaching Our 62304 Course

December 19, 2019
I am looking forward to teaching the IEC 62304 Course February 2020 with Brian Pate in Sunnyvale CA. https://events.eventzilla.net/e/2020-softwarecpr-62304-and-emerging-software-standards-training-course–sunnyvale-ca-2138757731 For 15 years I taught the AAMI Software Validation Course with Alan Kusinitz.  These days I have shifted gears to teach the SoftwareCPR 62304 course with Brian Pate. There is a major shift in my perspective between...
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14
Nov

FDA’s Digital Health “Ask A Question” Portal

November 14, 2019
Do you have a question about FDA Digital Health Regulatory Policy?  FDA’s Center for Devices and Radiological Health has a resource to help. I know from personal experience that the Digital Health Team (DHT) at FDA focuses a lot of energy and effort on answering these questions in an effective and efficient manner. During my...
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26
Sep

FDA Releases Digital Health Guidances

September 26, 2019
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...
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SoftwareCPR Training Courses:

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

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

Registration Link:

TBD

 

 

Being Agile & Yet Compliant (Public or Private)

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

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

2-days onsite (4 days virtual) with group exercises, quizzes, examples, Q&A.

Instructors: Mike Russell, Ron Baerg

Next public offering: March 7 & 28, 2024

Virtual via Zoom

Registration Link:

Register Now

 

 

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

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