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Dec

Another Warning Letter … and we still miss software validation

December 6, 2018Brian PateBlog

Glanced through the latest FDA warning letters today. From the FDA Medical Device & Radiological Health Operations West/Division 3 I see the inspector pointing out “This design validation also fails to include software validation [emphasis mine] to assure software will perform as intended and will not prevent safe operation by the user.” Of course this is...

Nov

Prescription Drug-Use-Related Software

November 28, 2018Brian PateNews

The Food and Drug Administration (FDA or the Agency) is announcing the establishment of a docket to solicit public comment on a proposed framework for regulating software applications disseminated by or on behalf of drug sponsors for use with one or more of their prescription drug products. Recognizing the opportunities for increased use of digital...

Nov

FDA CDRH Patient Advisory Committee Public Meeting

November 15, 2018Alan KusinitzNews

The Food and Drug Administration (FDA) is announcing a forthcoming public advisory committee meeting of the Patient Engagement Advisory Committee (the Committee). The general function of the Committee is to provide advice to the Commissioner, or designee, on complex issues relating to medical devices, the regulation of devices, and their use by patients. The meeting...

Oct

FDA Webinar Consensus Use of Standards

October 26, 2018Alan KusinitzNews

Oct

FDA Draft Cybersecurity Premarket Guidance

October 17, 2018Alan KusinitzNews

FDA issued a draft guidance “Content of Premarket Submissions forManagement of Cybersecurity in Medical Devices”, dated 10/17/18. This document contains some terms (e.g. Cybersecurity Bill of Material) and concepts (e.g., Tier 1 and Tier 2 risks) that is important for manufacturers to understand and address in premarket submissions. It also includes labeling recommendations for cybersecurity...

Oct

FDA CDRH Special 510(k) Pilot Program

October 15, 2018Jordan PateNews

FDA announces a new pilot program to simplify certain 510(k)s. For more information on eligibility click the link and scroll to near the bottom of the page.

Oct

FDA Final Guidance – Use of Standards Guidance

October 15, 2018Alan KusinitzNews

This final guidance, “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices,” replaces the 2013 draft guidance. This guidance focuses on clarifying and formalizing existing FDA practice including the requirement to submit FDA’s standards form for each standard used as well as discusses the use of obsolete standards. Originally standards were a...

Oct

FDA Final Risk Guidance – Different Technologies

October 11, 2018Brian PateNews

FDA released a final guidance "Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications 510(k) with Different Technological Characteristics" dated Sept. 25, 2018. This guidance applies only to devices with similar intended use and if the different technological characteristics do not raise different questions of Safety and Effectiveness. Read the full guidance at...

Oct

FDA CDRH 2019 New Guidance Plan

October 6, 2018Brian PateNews

FDA has posted their FY 2019 Proposed Guidance Development list with priorities. A link is provided below but here is the “A” list items: Final Guidance Topics Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions Unique Device Identification: Policy Regarding Compliance Dates for Class...

Oct

Manufacturers Assistance and Technical Training Branch (MATTB)

October 2, 2018Alan KusinitzNews

Email: Industry.Biologics@fda.hhs.gov Phone: 240-402-8020 or 1-800-835-4709 After hours (after 4:30 pm EST weekdays, all day on weekends, and federal holidays) FDA Emergency Call Center, Phone: 866-300-4374 or 301-796-8240 What The MATTB Does CBER’s Manufacturers Assistance and Technical Training Branch (MATTB) responds to public inquiries for information (by phone and email) from the biologics industry. MATTB strives to provide...

Oct

FDA CDRH Special 510(k) Pilot Program

October 2, 2018Alan KusinitzNews

Quality in 510(k) “Quik” Review Program Pilot The Quality in 510(k) (“Quik”) Review Program provides an alternate method to submit a premarket notification (510(k)) to the FDA using the eSubmitter software to format the submission. The FDA has identified a list of product codes that are eligible for this pilot. These device types are moderate risk and are considered...

Oct

FDA Reflects on National Cybersecurity Month

October 1, 2018Alan KusinitzNews

October is National Cybersecurity Month; for more information from FDA click the link.

Oct

FDA Biologics Assistance Branch (MATTB)

October 1, 2018Alan KusinitzNews

FDA Center for Biologics provides manufacturers with technical assistance. For email and phone contact information, and other information about this service, click the link.

Oct

FDA Device Center Patient Advisory Committee

October 1, 2018Alan KusinitzNews

Information on the FDA CDRH Patient Engagement Advisory Committee, including how to nominate candidates.

Sep

Recall – Power failure confuses software

September 19, 2018Jordan PateNews

Company: Fresenius Medical Care Renal Therapies Group, LLC Date of Enforcement Report: 9/26/2018 Class II: PRODUCT 2008T HEMODIALYSIS SYS, WITH CDX, Part Number 190713, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138 Product Usage: Indicated for acute and chronic dialysis therapy Recall Number: Z-3194-2018 REASON In the hemodialysis machine during the cleaning/disinfection...

Sep

US Code of Federal Regulations

September 12, 2018Jordan PateNews

For a quick and easy way to find US regulations, including those related to FDA, click the link provided.

Sep

FDA Medical Device Report Database

September 12, 2018Jordan PateNews

To search FDA MDRs, click the link provided.

Aug

Recall – Vertebral Motion Analyzer

August 31, 2018Jordan PateNews

Company:Canon Medical System, USA, INC. Date of Enforcement Report 9/12/2018 Class II: PRODUCT Vertebral Motion Analyzer (VMA) Version 2.3.252. VMA software is a quantitative imaging software application intended to be used to process digital image files. Recall Number: Z-2964-2018 REASON It was found when an operator performs a radiography using the wireless flat panel detector...

Aug

Recall – Hydra Vision Urology X-Ray System

August 29, 2018Jordan PateNews

Company: LIEBEL-FLARSHEIM COMPANY LLC Date of Enforcement Report: 8/29/2018 Class II: PRODUCT Liebel-Flarsheim Hydra Vision Urology X-Ray System (DR) Liebel-Flarsheim urology systems facilitate radiologic and/or fluoroscopic procedures requiring a beam of diagnostic quality radiation, primarily for urological applications such as functional x-ray diagnostics, endourology and minimal invasive urology/ surgery. Recall Number: Z-2833-2018 REASON Software issue....

Aug

Recall – Direct Digital Imaging System

August 29, 2018Jordan PateNews

Company: LIEBEL-FLARSHEIM COMPANY LLC Date of Enforcement Report 8/29/2018 Class II: PRODUCT Liebel-Flarsheim Direct Digital Imaging System (DDIS) Liebel-Flarsheim urology systems facilitate radiologic and/or fluoroscopic procedures requiring a beam of diagnostic quality radiation, primarily for urological applications such as functional x-ray diagnostics, endourology and minimal invasive urology/ surgery.uch as functional x-ray diagnostics, endourology and minimal...

Aug

Warning Letter – Lack of Data Integrity

August 29, 2018Brian PateNews

Pharmaceutical Laboratories and Consultants, Inc. Date:8/29/18 This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 21 CFR, parts 210 and 211. Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of...

Aug

Warning Letter – Pharmaceutical Laboratories and Consultants Inc

August 29, 2018Alan KusinitzNews

Pharmaceutical Laboratories and Consultants, Inc. Product: testing laboratory Date:8/29/18 This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 21 CFR, parts 210 and 211. Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within...

Aug

Recall – Cardiology Hemo

August 21, 2018Jordan PateNews

Company: McKesson Israel Ltd.. Date of Enforcement Report 9/12/2018 Class II: PRODUCT McKesson Cardiology Hemo, Release SW version 13.0. Used for physiological monitoring, image and data processing. McKesson Cardiology Hemo is intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment. McKesson Cardiology Hemo is also intended for patient/procedural...

Aug

Warning Letter – Cybersecurity of Electronic Records

August 10, 2018Jordan PateNews

Yuki Gosei Kogyo Co., Ltd. Date:8/10/18 Failure to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data, and failure to have adequate controls to prevent omission of data. Your firm’s controls over your HPLC systems are inadequate. Some HPLC systems did not have audit trail capability or audit trails enabled....

Aug

FDA Regulation of Mobile Medical Apps

August 1, 2018Amy SellersBlog

The latest communication from FDA regarding regulation of medical apps notes that mobile medical apps can greatly help patients be proactive and vigilant about their own healthcare. There has been increased demand for medical apps, and many of the apps depend on high levels of feedback between patients and clinicians. The FDA wants to regulate...

Aug

FDA Raises User fees Oct 1, 2018

August 1, 2018Alan KusinitzNews

Also states the new annual registration fees. Keep in mind, businesses with gross revenue under USD $100 million qualify for the reduced small business fees listed.

Jul

FDA Benefit-Risk Analysis Summary

July 29, 2018Amy SellersBlog

What concerns FDA when conducting a benefit-risk assessment of medical devices? The answer is a long list of variables that can vary by type of device, target population, and indications for use, but the clear focus is on patient safety and benefit. The FDA considers both the device benefit-risk assessment, as well as evidence and...

Jul

FDA Examples of Cleared Apps

July 27, 2018Jordan PateNews

FDA provides examples of cleared Mobile Medical Apps.

Jul

FDA Software Precertification News

July 27, 2018Amy SellersBlog

Software-based medical devices tend to develop more quickly than typical hardware-based medical devices; so, in response, the FDA has turned to an agile regulatory model for software as a medical device (“SaMD”). The FDA describes the Software Precertification Program as a voluntary pathway, with tailored assessments of the safety and effectiveness of software technologies. Rather...

Jul

FDA Clears Home Urinalysis Using Smartphones

July 27, 2018Jordan PateNews

Dip.io was cleared for clinical urinalysis. The device includes test strips and a color coded card that is readable by smartphone to provide a result for several conditions including infection.

Jul

JAMA Article by FDA Staff – Summary

July 17, 2018Amy SellersBlog

Jul

Warning Letter – Data integrity

July 17, 2018Jordan PateNews

Yuki Gosei Kogyo Co., Ltd. Date:7/17/18 Data Integrity Remediation: Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. We strongly recommend that you retain a qualified consultant to assist in your remediation. In response to this letter, provide the...

Jul

Warning Letter – Data integrity

July 5, 2018Jordan PateNews

Company: Baxter (Claris Injectables Ltd.) Date: 7/5/18 Data Integrity Remediation: Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. In response to this letter provide the following. A. A comprehensive investigation into the extent of the inaccuracies in data,...

Jun

FDA eSubmitter Download Webpage

June 29, 2018Alan KusinitzNews

For information on FDA eSubmitter downloading and installation see the link. Let’s save the trees folks…

Jun

Warning Letter – Incomplete data

June 12, 2018Jordan PateNews

Product: drug manufacturing facility

Jun

FDA Q-Submission Program Draft Guidance

June 7, 2018Jordan PateNews

FDA issued the draft guidance “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program” June 7, 2018. Note that there are a variety of types of Q-submissions and they do not need to be tied to a specific planned 510(k) or other premarket submission. Also note that they are not meant to...

Jun

FDA Proposed Reclassification of MIMS

June 1, 2018Jordan PateNews

FDA Issued a Proposed Order to Down-Classify Certain Radiological Medical Image Analyzers, which include computer-assisted detection devices for mammography breast cancer, ultrasound breast lesions, radiograph lung nodules, and radiograph dental caries detection devices, from class III to class II devices. If finalized, this proposed order will reclassify computer-assisted detection devices for certain radiological applications from...

May

Warning Letter – Data integrity

May 23, 2018Jordan PateNews

Product: drug manufacturing facility

May

FDA Draft MultiFunction Device Guidance

May 1, 2018Jordan PateNews

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

Software Standards and FDA Guidance Visual Aid

March 23, 2018Brian PateBlog

Prepared a visual aide (one of many we use in our training courses) of key Medical Devices Standards and FDA guidance related to software. Enjoy! SoftwareCPR Sw Stds Guidances

Mar

Production and Process Validation

March 14, 2018Alan KusinitzBlog

This content is only available to Premium level and Standards Navigator subscribers. See our Subscribe page for information on subscriptions. SoftwareCPR has prepared a collection of production and process validation material suitable for training in Production and Quality Systems 820.70(i) Validation including Part 11. Portions could be made into handouts or provided electronically. Download the manual...

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 Voluntary Device Malfunction Summary Reporting

December 26, 2017Alan KusinitzNews

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...

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Being Agile & Yet Compliant (Public)

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

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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

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