Jordan Pate, Author at SoftwareCPR

FDA issued a draft guidance dated April 27, 2018 titled: “Multiple Function Device Products: Policy and Considerations.” This guidance expands on when and how FDA intends to assess the impact of other functions that are not the subject of a premarket review on the safety and effectiveness of a device function subject to FDA review. It...

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FDA Draft Guidance Expansion of Abbreviated 510(k)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FDA issued a draft guidance for comment: Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Contains Nonbinding Recommendations Draft – Not for Implementation Equivalence through Performance Criteria.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.

Apr

FDA Unique Device Identifier Webpage Status Update

April 6, 2018Jordan PateNews

The Global Unique Device Identification Database is a database administered by the FDA that will serve as a reference catalog for every device with an identifier. May 2018 will start implementation of the releasability logic and the review period. Public release of premarket submission and supplement numbers on AccessGUDID and OpenFDA will begin in June 2018.

Mar

SoftwareCPR March 2018 Newsletter

March 29, 2018Jordan PateNews

This newsletter in pdf form lists items added to the web site from mid-November 2017 through late-November 2018. It serves as an easy reference to find new or updated items that may be of interest to you. Please search the library to see all items posted as the newsletter only lists new or updated ones....

Mar

SoftwareCPR® Mobile App with Regs and Guidance

March 3, 2018Jordan PateNews

You can search the app stores for SoftwareCPR® to download on an iPhone or Android. The app provides key FDA regulations and Software Guidances for quick reference and is organized by section. Impress your friends by accessing the exact text of FDA documents wherever you go. We plan to add additional documents over time.

Feb

FDA Premarket Clinical Data FAQ Guidance

February 22, 2018Jordan PateNews

The FDA published the guidance document “Acceptance of Clinical Data to Support Medical Device Applications and Submissions Frequently Asked Questions.” The guidance document is in Q&A format, and provides clarifications and recommendations to help stakeholders ensure that studies conducted in the U.S. or foreign countries comply with the new rule and revised regulations. FDA Website

Jan

FDA Final Revised Refuse to Accept Policy

January 30, 2018Jordan PateNews

The FDA published the guidance document “Refuse to Accept Policy for 510(k)s.” This supersedes the original, issued on August 4, 2015. This revision provides for additional requirements to better ensure substantive content, not just administrative elements that are checked in the initial 15 day refuse to accept initial review. Refuse to Accept Policy for 510(k)s

Jan

FDA UDI Class I and Unclassified Policy Guidance

January 16, 2018Jordan PateNews

The U.S. Food and Drug Administration released the immediately-in-effect (IIE) guidance document, “Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices.” The guidance lists and explains several key elements of FDA’s enforcement discretion policy, including the Agency’s intention to not enforce standard date formatting, labeling, and GUDID data submission requirements for...

Dec

FDA Voluntary Device Malfunction Summary Reporting

December 26, 2017Jordan PateNews

The U.S. Food and Drug Administration issued a Federal Register notice with a proposed program for Voluntary Malfunction Summary Reporting. When finalized, this program would allow manufacturers to report certain malfunction medical device reports (MDRs) in a summary format on a quarterly basis instead of individually within 30 days. The proposed Voluntary Malfunction Summary Reporting...

Dec

FDA Device Accessories Classification Guidance

December 20, 2017Jordan PateNews

Today the FDA is announcing the availability of the updated final guidance, “Medical Device Accessories – Describing Accessories and Classification Pathways”. This guidance was updated and replaces the Jan 2017 version to include new mechanisms to request (1) a different classification for an existing accessory type (i.e., accessories already on the market), and (2) for...

Dec

Warning Letter – Violation of cGMP

December 18, 2017Jordan PateNews

Product: drug manufacturing facility

Dec

FDA CDRH 2018 Proposed Guidance Development

December 14, 2017Jordan PateNews

FDA issued its list of planned Medical Device Guidance development for 2018. This list has 2 parts: priority development referred to as the A-List and other development referred to as B-list.. Note that FDA does not commit to accomplishing all items on either list; it is just stating its current intention. The A-List includes a...

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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.

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

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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

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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

Recall – Fully automated critical care analyzer software bug

Recall – Fully automated critical care analyzer software bug

Recall – Fully automated critical care analyzer software bug

Recall – POC data management system software bug

FDA Draft MultiFunction Device Guidance

FDA Draft Guidance Expansion of Abbreviated 510(k)

FDA Unique Device Identifier Webpage Status Update

SoftwareCPR March 2018 Newsletter

SoftwareCPR® Mobile App with Regs and Guidance

FDA Premarket Clinical Data FAQ Guidance

FDA Final Revised Refuse to Accept Policy

FDA UDI Class I and Unclassified Policy Guidance

FDA Voluntary Device Malfunction Summary Reporting

FDA Device Accessories Classification Guidance

Warning Letter – Violation of cGMP

FDA CDRH 2018 Proposed Guidance Development

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