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Dec

FDA Clinical Decision Support SW Draft Guidance

December 11, 2017Alan KusinitzNews

On Dec. 8, 2017 FDA released a Draft guidance “Clinical and Patient Decision Support Software”. This guidance addresses software for decision support in two categories: one used by Healthcare Professionals, the other used personally by patients and non-health professionals. It provides FDA interpretation of which types of Decision Support Software do not meet the definition...

Dec

FDA Changes to Medical SW Policies Draft Guidance

December 11, 2017Alan KusinitzNews

On Dec. 8, 2017 FDA released a Draft guidance “Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act”. This guidance dsicusses software functions in relation to the modified device definition in the 21st Century Cures Act and the criteria for interpreting if and how medical software will or...

Dec

FDA New Digital Health Policy Statement

December 9, 2017Alan KusinitzNews

On December 7, 2017, FDA Commissioner Scott Gottlieb, M.D., released the statement, “Advancing new digital health policies to encourage innovation, bring efficiency and modernization to regulation.” This statement announces the release of several new draft and final guidances as part of the FDA’s Health Innovation Action Plan published previously. The new guidances are posted separately...

Dec

FDA Digital Health Innovation Action Plan

December 8, 2017Alan KusinitzNews

Earlier this year FDA released the DH Action Plan, initiating several new guidances, policy changes, and its pre-certification program. Note: Information on the pre-certification program progress during 2017 and release of new guidance (December 2017) is posted separately.

Dec

Medical Device Section 21st Century Cures Act

December 1, 2017Alan KusinitzNews

An excerpt of the Medical Device Innovations Section of the US Law PLAW-114Publ255 referred to as the “21st Century Cures Act” and published in December of 2016 is at the link provided. There are many important elements of this law, including how accessories are classified and what software functions are not outside the definition of...

Dec

FDA Digital Health Webpage

December 1, 2017Alan KusinitzNews

The FDA maintains a dedicated webpage to provide ongoing information on FDA’s digital health initiative.

Nov

Free Android App with FDA regulations

November 17, 2017Amy SellersNews

Want a free Android app as a quick reference to the regulations? Paul Felten of SoftwareCPR has developed a new app just for that purpose. You can find it by searching for “SoftwareCPR” in the Google Play store! Google Play – SoftwareCPR app

Nov

FDA Approves Digital Pill

November 16, 2017Amy SellersNews

The FDA issued its first approval of a Digital Medicine, ABILIFY MYCITE®, a new innovative treatment option in mental health. Otsuka, with the help of Proteus Inc., developed a sensor as part of the pill that communicates externally to provide confirmation the pill was ingested, along with details about it. This is for serious mental...

Oct

FDA MDDS – Still Confusing After All This Time

October 31, 2017Alan KusinitzBlog

FDA regulation of Medical Device Data Systems has changed significantly over the years. This, together with the blurred line between MDDS and general health information technology, interfaces between MDDS and regulated medical devices, the actual criteria for deciding if something is classified as a Medical Device Data System, and different regulatory requirements outside the US...

Oct

FDA Final De Novo Submission Guidance

October 31, 2017Amy SellersNews

The FDA release a final guidance, “De Novo Classification Process (Evaluation of Automatic Class III Designation),” on October 30, 2017. This supersedes “New Section 513(f)(2) – Evaluation of Automatic Class III Designation, Guidance for Industry and CDRH Staff” dated February 19, 1998. This guidance defines the process for De Novo submissions for devices with no...

Oct

FDA Breakthrough Devices Program Draft Guidance

October 25, 2017Amy SellersNews

The FDA published a draft guidance, “Breakthrough Devices Program Draft Guidance for Industry and Food and Drug Administration Staff,” on October 25, 2017. The full guidance is at the link provided. This supersedes the Expedited Access Pathway (EAP) introduced in 2015 and the Priority Review Program. The Breakthrough Devices Program is a voluntary program for...

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...

Oct

FDA Breakthrough Devices Program Draft Guidance

October 25, 2017Alan KusinitzNews

FDA published a draft guidance “Breakthrough Devices Program Draft Guidance for Industry and Food and Drug Administration Staff” dated 10/25/17. The full guidance is at the link provided. This supersedes the Expedited Access Pathway (EAP) introduced in 2015 and the Priority Review Program. The Breakthrough Devices Program is a voluntary program for certain medical devices...

Oct

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

October 25, 2017Alan KusinitzNews

Supersedes 1997 guidance. FDA issued a new Final guidance entitled “Deciding When to Submit a 510(k) for a Change to an Existing Device” dated Oct. 25, 2017. TThe full guidance is at the link provided. Note that FDA simultaneously released a Final guidance for when to submit a new 510(k) for software changes specifically. Deciding When...

Oct

Retrospective Validation

October 17, 2017Alan KusinitzBlog

I don’t even really like to use the word retrospective

Oct

Warning Letter – Kim Chemicals Private Ltd.

October 16, 2017Amy SellersNews

The firm's quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs manufactured - remediation required

Sep

FDA Pre-submission Meeting Guidance

September 29, 2017Alan KusinitzNews

The U.S. Food and Drug Administration released guidance document, “Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff,” dated September 29, 2017. The guidance lists and explains the process for requesting meetings with the FDA. It explains proper use of these meetings, including examples of appropriate...

Sep

FDA PMA Critical to Quality Pilot Program

September 15, 2017Amy SellersNews

The PMA CtQ pilot program aims to evaluate device design and manufacturing process quality information early on, giving the applicants the option of foregoing the standard PMA pre-approval inspection

Sep

FDA Recognizes AAMI TIR69 Wireless Coexistence

September 15, 2017Alan KusinitzNews

"AAMI TIR69: Risk Management of Radio-frequency Wireless Coexistence for Medical Devices and Systems" available for purchase

Sep

FDA PMA Critical to Quality Pilot Program

September 15, 2017Alan KusinitzNews

Participation in the PMA CtQ pilot program is voluntary and the program aims to evaluate device design and manufacturing process quality information early on to assist FDA in its review of the PMA manufacturing section and post-approval inspections. This voluntary pilot program is part of the FDA’s ongoing Case for Quality effort to apply innovative...

Sep

Warning Letter – Wuxi Medical Instrument Factory

September 7, 2017Amy SellersNews

Significant violations of CGMP regulations due to failure to maintain adequate written records of major equipment maintenance and data integrity issues

Sep

FDA Final Guidance: Interoperable Devices

September 6, 2017Amy SellersNews

The FDA issued the final guidance entitled “Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices.” This guidance addresses medical devices that exchange information; whether wired or wireless, or through the internet. It includes unidirectional exchange, bidirectional, or command and control. The guidance focuses on data exchange not physical connection types. It includes a...

Aug

FDA Abbott Cybersecurity Safety Communication

August 30, 2017Alan KusinitzNews

On August 29, 2017, the FDA issued “Firmware Update to Address Cybersecurity Vulnerabilities Identified in Abbott’s (formerly St. Jude Medical’s) Implantable Cardiac Pacemakers: FDA Safety Communication.” The full document is at the link provided. Firmware Update to Address Cybersecurity Vulnerabilities in Abbott Pacemakers

Aug

A Collaborative Approach to Test Debt

August 30, 2017Paul FeltenBlog

Testing activities should neither end with the release of the product nor once test documentation is complete, but should continue with the reduction of any test debt. Test debt is essentially a form of technical debt. Like technical debt, test debt is incurred during a project when compromises are made in the creation of test...

Aug

IEC 82304 and other FDA newly recognized standards

August 25, 2017Alan KusinitzNews

The FDA published a list of standards added to their recognition list on August 21, 2017. IEC 82304-1 Edition 1.0 2016-10. Health software part 1: General requirements for product safety are included on this list in the Software/Informatics Section, along with a number of other standards related to device communication (including specifics of glucose meters...

Aug

FDA Recognizes UL2900-1 for Cybersecurity

August 21, 2017Alan KusinitzNews

UL 2900-1 Ed.1 2017 Standard for Software Cybersecurity Network-Connectable Products, Part 1: General Requirements was recognized by FDA on August 21, 2017. See at: FDA Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 047.

Aug

FDA Digital Health Precert Pilot FAQ

August 9, 2017Amy SellersNews

The FDA published a FAQ for companies that may be interested in participating in the Digital Health Software Precertification Program.

Aug

FDA Digital Health Precert Transcript and Video

August 3, 2017Amy SellersNews

The FDA held a meeting and webcast regarding initial development of its new approach for Digital Health Regulation. The FDA’s Digital Health Precertification webpage is at the link provided, and the slides from their presentation can be downloaded.

Aug

FDA Digital Health Precert Meeting Summary

August 3, 2017Brian PateNews

"Based upon the company’s precertification level and the level of risk for the device, the product (or modifications to a product) may be able to go directly to market or undergo a streamlined submission review"

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...

Jun

FDA Draft Part 11 for Clinical Investigations

June 26, 2017Alan KusinitzNews

FDA issues a new draft guidance in June 2017 titled “Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers”. This guidance while scoped for clinical investigations has information that is probably useful and defensible for assessing or ensuring compliance with other types of systems subject...

Jun

FDA Tutorial E-submission of 806 reports

June 26, 2017Alan KusinitzNews

FDA CDRHLearn released a new tutorial entitled ‘Electronic Submission of 806 Reports of Corrections and Removals”. The full tutorial is at the link provided. FDA Tutorial E-submission of 806 reports

Jun

FDA Safety Alert – Stereotactic Navigation Systems

June 18, 2017Alan KusinitzNews

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm563249.htm

Jun

FDA New Digital Health Health and SaMD Initiative

June 15, 2017Alan KusinitzNews

http://blogs.fda.gov/fdavoice/index.php/2017/06/fostering-medical-innovation-a-plan-for-digital-health-devices/

May

21 CFR Part 11

May 9, 2017Brian PateNews

We help you meet the intent of the rule -- not the hype

Apr

FDA Interoperability Final & Cybersecurity Revision

April 24, 2017Alan KusinitzNews

At the AAMI/FDA Software Regulatory Class being held this week, it was stated that the following are expected to be released this summer by FDA: – Revision to the premarket cybersecurity guidance – Final of the interoperability guidance

Apr

FDA Use of Symbols in Medical Device Labeling

April 24, 2017Alan KusinitzNews

The FDA page on Medical Device Use of Symbols in Labeling is at the link provided. FDA currently allows use of symbols in place of text for medical devices and certain biologics provided the use is compliant with 21 CFR Parts 660, 801, and 809. FDA Use of Symbols in Medical Device Labeling

Mar

FDA Experiential Learning Program Applications

March 22, 2017Alan KusinitzNews

FDA seeks manufacturers to provide onsite learning opportunities for FDA staff. In the areas of Digital Health/Software FDA is interested in 4 topics: Cybersecurity, Software Development, Total product life-cycle development processes and methodologies, and Software testing. The link provided is the main FDA webpage on this program and has a link to the full list...

Mar

FDA Draft Class II Device 510(k) exemptions

March 21, 2017Alan KusinitzNews

FDA issued a draft list of Class II Medical Devices exemptions from the 510(k) premarket notification requirements to comply with the 21st Century Cures Act. Note that 884.1630 is NOT exempt if it contains software for image analysis or smartphone use. Other software-related sections of note are 86.2570 and 882.1470.

Mar

FDA Presentation on Benefit-Risk IDE Devices

March 4, 2017Alan KusinitzNews

The presention material for the FDA Webinar – Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions Final Guidance – February 23, 2017 is at the link provided. FDA Presentation on Benefit-Risk IDE Devices

Jan

FDA Postmarket Cybersecurity Guidance Webinar

January 24, 2017Alan KusinitzNews

FDA issued a Final guidance entitled: “Postmarket Management of Cybersecurity in Medical Devices”. FDA held a free webinar on this guidance on Jan. 12,2017. Information information and presentation materials are at the link provided. SoftwareCPR can provide expert cybersecurity consulting services for regulatory compliance andrisk analysis, technical threat and vulnerability assessment as well as for...

Jan

FDA Draft medical Device product Communications

January 21, 2017Alan KusinitzNews

The FDA issued a draft guidance “Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers”. The full draft is at the link provided. Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers

Jan

Warning Letter – Morton Grove Pharmaceuticals, Inc.

January 17, 2017Jordan PateNews

Company: Morton Grove Pharmaceuticals, Inc. Date:1/17/2017 Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)). Data Integrity Remediation Your quality system does not adequately ensure the accuracy and integrity of data to...

Jan

21st Century Cures Act

January 15, 2017Alan KusinitzNews

The US Law PLAW-114Publ255 referred to as the 21st Century Cures Act published in Dec 2016 is at the link provided. There are many important elements of this law for Drugs, Devices, and Biologics. 21st Century Cures Act

Jan

Warning Letter – FACTA Farmaceutici S.p.A Ltd.

January 13, 2017Jordan PateNews

FACTA Farmaceutici S.p.A Product: drug manufacturing facility Date:1/13/2017 1. Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards (21 CFR 211.194(a)). For multiple sterile drug product lots, your original data showed failing results, but data you reported showed passing results....

Jan

FDA FINAL Guidance Benefit-Risk IDE Devices

January 13, 2017Alan KusinitzNews

The US FDA issued a FINAL guidance entitled: “Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions”. This guidance references software features in Appendix C the device description section. The full guidance is at the link provided. FDA FINAL Guidance Benefit-Risk IDE Devices

Jan

Implantable Device FDA Cybersecurity Notice

January 10, 2017Alan KusinitzNews

FDA issued a safety notice: Cybersecurity Vulnerabilities Identified in St. Jude Medical’s Implantable Cardiac Devices and Merlin@home Transmitter.

Jan

21st Century Cures Act – SCPR SW Impact Analysis

January 10, 2017Alan KusinitzNews

What the 21st Century Cures Act Means for Software Manufacturers The 21st Century Cures Act (“Cures Act”), was signed into law by the President on December 13, 2016 (Public Law No. 114-255). This article focuses on section 3060 of the new law; namely “Clarifying Medical Software Regulation.” Other sections of the act address medical devices...

Jan

FDA Device Recall Summary Page

January 4, 2017Alan KusinitzNews

The FDA webpage with a summary of how medical device recalls are handled and how FDA may notify the public is at the link provided. This includes examples of types of recall actions. We post software-related recalls on this website and SoftwareCPR can provide expert assistance in compliance with 21 CFR Part 806 Corrections and...

Jan

21st Century Cures Act – Medical Device Summary

January 4, 2017Alan KusinitzNews

Hyman, Phelps & McNamara posted a great summary of the impact of the 21st Century Cures Act in regards to general provisions affecting medical device regulation. They also provide links to summaries of other provisions of the act for standalone software (also posted on softwarecpr.com), and drugs and biologics impact.

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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:

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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