November 18, 2020

Medical Device Manufacturers Transitioning to ISO 14971:2019 Need to Perform a Gap Analysis and Create a Cross-Functional Risk Management Team

Author: Nupur Srivastava, PhD 

There has been a lot of discussion on the updated International Organization for Standardization (ISO) 14971:2019,  and experts agree that medical device manufacturers need to perform a gap analysis and create a cross-functional team to meet these risk management requirements.  

Risk management plays a critical role in getting medical devices into the market, and ISO 14971:2019 “was designed to better align with medical device regulations around the world.” The global regulatory landscape has been very dynamic around the areas of risk management, as well as safety and performance. 

Tips on Putting Risk Management into Quality Systems During the Transition to ISO 14971:2019 

Two experts shared insights during an interview with Medtech Insight. Jos Van Vroonhoven, convener of ISO Technical Committee 210, Joint Working Group 1 (TC210/JWG1) and a senior manager for standardization for device giant Philips Healthcare, and Don Powers, a member of ISO TC210/JWG1 and long-time industry expert, said that the third edition of ISO 14971 provides more precise guidance and greater detail in the application of risk management concepts.  

These experts provided specific tips on how to transition ISO 14971:2019 into your device’s quality systems.  

Since ISO 14971:2019 instructs manufacturers how to best put together risk management programs, this is a good time to review risk management procedures and perform Gap Assessments. 

  • Develop a Gap Assessment Team 
    • Led by quality assurance or a designated risk manager 
    • Consisting of members with expertise in:
      • Clinical knowledge of the device 
      • Regulatory knowledge, global if needed 
      • Manufacturing of the device 
      • Design and development 
      • Marketing 
      • Reliability engineer and service organization, if available 
  • Divide the Gap Assessment Team and Conquer Each Area 
    • Compare required ISO 14971:2019 to current company processes 
    • Determine how this will impact each department 
  • Document Risk Management to Evaluate Residual Risk 
    • The panelist placed particular emphasis on residual risk, or the risk that remains after risk control measures have been implemented, which is new in ISO 14971:2019. Evaluating and Setting criteria for risk management can be found in Clause 4.4e Risk Management. 

How Do You Know If You are On the Right Track? 

Create another team to evaluate residual risks. This group needs to form a cross-functional team of experts with application and clinical knowledge that can provide good judgment for the residual risk of the medical device.  

The example provided explored the residual risk of x-ray equipment. In this case, the residual risk team might be comprised of individuals with expertise in the following areas. 

  • Radiation  
  • Technical director 
  • Chief medical officer  
  • Clinical scientist that understands how the equipment is used in hospitals. 

The standards outlined in ISO 14971:2019, like benefit-risk analysis, are now in demand by global regulators.  

Global Regulations 

The ISO 14971 standards were updated in 2019 in the United States and the European Union to conform to the higher expectation of identifying and mitigating risks associated with a medical device throughout its lifecycle.  

In the US, FDA requires device manufacturers to align with ISO 14971:2019 by the end of the transition period December 25, 2022, after which time FDA will no longer accept the previous ISO 14971:2007 version.  

In Europe, ISO 14971:2019 (EN version) aligns with the Medical Device Regulations (MDR) and In Vitro Diagnostic Regulation (IVDR) safety and performance requirements. Although it is not yet harmonized with these standards, ISO 14971:2019 is expected to become a Harmonized standard, which will make it state-of-the-art. The date of application for MDR (26 May 2021) and IVDR (26 May 2022) is quickly approaching.   

Globally, ISO 14971:2019 is considered the international standard for risk management and is referenced, if not endorsed, by all other major markets that require the application of risk management including, Australia TGA, Brazil, Health Canada, and Japan MHLW.  

Therefore, device manufacturers must begin to transition into compliance with the revised version of ISO 14971:2019 to align with global regulations. 

History of ISO 14971

The first edition of ISO 14971 was released in 2000 to assist manufacturers, regulatory bodies, and healthcare providers in managing the medical devices’ potential risks. This picture depicts the evolution of ISO 14971 from 2000 to 2019.  

Progression of ISO 14971  

As global regulations for medical devices are becoming more stringent, clear documentation of the process and presentation of the data are essential components of getting medical devices to market. Criterion Edge has a team of expert medical writers that can help your organization get the required documents completed in a timely manner.   
Please reach out to us for a free consult. 

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November 12, 2020

[FREE WEBINAR] Hidden Traps That Derail PER Preparedness: Lessons Learned from the MDR-Compliant CER Writing Experience

Get a copy of the slides from this webinar or click to watch the recording.

With the implementation of IVDR requirements, IVD manufacturers have been challenged to align their internal processes and systems to comply with these rigorous regulations. In this practical presentation, Criterion Edge uncovers what we have learned from our experience in writing MDR-compliant CERs, and how urgently applicable some of these key learnings are in preparing a robust Performance Evaluation Report (PER). 

Who should watch this webinar? 

Those Regulatory, Quality and Clinical leaders and regulatory writers who are tasked with the development, writing, review or approval of Performance Evaluation Reports for EU IVDR submission, or anyone interested in learning more about IVDR requirements for PERs. 

Sign up for future webinars here.

Criterion Edge has the expertise and resources to do literature reviews for many types of documents. Ready for a free consult?

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November 9, 2020

FDA’s Updated Electronic Medical Device Reporting (eMDR) System Aims to Harmonize Adverse Event Reporting

Author: Suzanne Broussard, PhD 

Two doctors discussing about medical report in clinic

FDA’s recently finalized modifications to the electronic Medical Device Reporting (eMDR) system include the addition of new fields to harmonize with terminologies set by the International Medical Device Regulators Forum (IMDRF). These changes are designed to “improve transparency and analysis of the MDR data contained in the public Manufacturer and User Facility Device Experience (MAUDE) database” and are part of the FDA’s push for regulatory harmonization. 

Device manufacturers now have until February 28, 2021 to use IMDRF codes instead of the retired Patient Problem Codes and Device Component Codes. The original production deployment date of September 7, 2020 was extended to give manufacturers a little more time to adapt to the changes.  

Here is a summary of the updates to the eMDR system

  • Includes new elements for Summary Report and NOE (Number of Events) based on FDA Form 3500A so that submitters will not need to report this information in B5 (Event Narrative) with precise text formatting  
  • Addition of adverse event codes to harmonize with IMDRF Annex E, F, G Codes  
  • FDA Adverse Event codes update that affect the Device Problem Codes and Manufacturer Evaluation Code 
  • New options in the patient gender field 
  • New elements or changes to Exemption Number reporting, indications to submission environments, and B5 and H1 (now mandatory) to reject options not reported properly 
  • Enable a reporter to identify whether the report relates to a combination product 
  • Combination product fields added to allow submitters to include information of up to 20 drugs within a device-led combination product adverse event report 

The current eMDR reflect FDA’s updates to Form 3500A, which is used by medical device manufacturers, importers, distributors, and user facilities to report diverse events and other system enhancements. 

FDA further aligned this reporting system by adding two fields from FDA Form 3500A to the public MAUDE database to provide additional information on related devices and the nature of adverse events. 
  • Patient problem codes 
  • Marketing submission number (for submissions such as 510(k) and PMA) 

To help manufacturers with a smooth transition to the newest eMDR format, the Center for Devices and Radiological health (CDRH) has created a downloadable file package to assist in implementing software for generating the HL-7ICSR XML for eDMR submissions. And updates on new and retired codes MDR Adverse Codes are easy to find. 

The updated eMDR is one of many changes being implemented by FDA. Indeed, 2020 has been an active year for FDA as they work to harmonize across systems.  

Here is a short list of posts with additional information on specific programs recently updated by FDA

It takes a team of experts to implement all the regulatory documentations required to get and keep your medical device in compliance, especially ever changing and demanding US and European regulatory requirements.  

If your organization needs support establishing or updating technical documents for medical devices, Criterion Edge has a team of document experts ready to partner with you. Please reach out to us for a free consult. 

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November 2, 2020

Nuances of Using the Safety and Performance Pathway for Submitting a 510(k) for Certain Device Types

Author: Suzanne Broussard, PhD 

The FDA is moving forward with its commitment to strengthen and modernize the 510(k) program. The Safety and Performance Based Pathway is designed to provide a direct and transparent approach to demonstrating safety and effectiveness of low to moderate risk devices that can meet FDA-identified performance criteria to demonstrate substantial equivalence.  

The first device specific guidance documents for Conventional Foley Catheters and Cutaneous Electrodes for Recording Purposes were released in August 2020. More recently, FDA hosted a webinar providing some key points to consider when submitting a 510(k) to the Safety and Performance Based Pathway.   

Background information on the Safety and Performance Based Pathway and guidance documents can be found here

Below is a summary of the nuances that FDA wants your organization to consider if you are in the process of submitting a 510(k) or are considering submitting a 510(k) for well-understood Class II devices through the new Safety and Performance Pathway for Certain Device Types.  

First, manufacturers must determine if the device is appropriate for the pathway. The scope of each device-specific performance criteria guidance identifies device types that are appropriate. The guidance indicates which performance device-specific criteria need to be meet, and all criteria outlined must be met.  

Secondly, it is still necessary to identify an appropriate predicate for your submission, even though it is not necessary to conduct side by side performance testing of the subject test to the predicate device.  

Third, new submissions through the Safety and Performance pathway are evaluated through the same 510(k) substantial equivalence decision flowchart as before. What is unique about this pathway is that to demonstrate performance the subject device must meet all of the FDA identified criteria listed in the device specific guidance. FDA believes this is important as criteria to appropriately determine substantial equivalence “when the indications for use and technological characteristics do not raise different questions of safety and effectiveness from that of the predicate device. And, that the criteria align with one or more predicates of the same device type.” 

Key Points to Consider When Submitting a 510(k) to the Safety and Performance Pathway:

  • The Safety and Performance pathway will have a Medical Device User Fee Amendment (MDUFA) review clock of 90 days, similar to the traditional and abbreviated pathways. 
  • The MDUFA user fee is the same as other 510(k) submissions. 
  • Manufacturers should identify that their submission is intended for the Safety and Performance pathway to allow FDA to adequately process the submission in the system. 
  • The Refuse to Accept process (RTA) is consistent with the RTA policy guidance and is similar to the abbreviated 510(k) RTA checklist.  
  • The timeframes for RTA and substantive interaction is the same as other 510(k)s. 
  • There is an opportunity for 510(k)s submitted to the Safety and Performance pathway to be converted if there are issues that preclude review through this pathway. 

What if the device does not meet the Safety and Performance pathway criteria after submission? 

The determination for whether a device is appropriate of the Safety and Performance 510(k) pathway is typically made during the RTA review stage. During the RTA review stage, if the submission does not have sufficient information or does not meet the criteria there is an opportunity for conversion to another viable 510(k) pathway. However, the conversion may necessitate additional testing that includes a predicate device.   

Take Advantage of the Pre-submission or Q-Submission (Q-Sub) process to get further clarification as to whether your device is appropriate for any of the 510(k) pathways.  

The FDA offers Q-Sub as an opportunity for manufacturers to obtain FDA feedback prior to an intended submission. These meetings are voluntary but can provide valuable insights for manufacturers on both potential and planned medical devices, as well as biologics and drug submissions. The Q-sub meetings are a great avenue to ask FDA questions, gain valuable feedback, and get a documented formal response that can be of future use.  

The Q-Sub process can also be used which test methods outside those recommended by FDA are appropriate to meet the identified performance criteria.  

Additionally, Q-Sub can be used if additional testing that your organization identified outside of the guidance is necessary to demonstrate the devices safety and performance on a case-by-case basis. The example FDA provided regards adding language to labeling in cases where performance testing is not included in the device-specific guidance. Under this circumstance, additional testing is required.  

FDA Encourages Manufacturers to Be Involved 

  • All stakeholders are encouraged to submit comments during the public commenting period on the device-specific performance criteria draft guidance.  
  • The docket for safety and performance guidance will remain open for suggestions, and it is regularly monitored.  

FDA also included a list of the following resources:  

Need Expert Medical Writers for Submission Support? 

Getting these technical documents together for any 510(k) submission takes expertise and time. Criterion Edge has experience medical writers that can provide support developing and producing your devices 510(k) submissions or pre-submissions. Please reach out to us for a free consult.  

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October 26, 2020

FDA Finalized Two Guidance Documents for the Abbreviated 510(k) Safety and Performance Based Pathway: Use of Performance Measurements Instead of Direct Comparison Testing for Medical Devices

Author: Suzanne Broussard, PhD 

man on books

The Premarket Notification 510(k) Program is the pathway used by manufactures of low- to moderate-risk devices that are substantially equivalent to a device already on the market. Device manufacturers can submit 510(k)s as Traditional, Special, or Abbreviated. See our previous post for an overview of the 4 guidance documents released by FDA in September of 2019.  

The Safety and Performance Based Pathway Guidance for Conventional Foley Catheters and Cutaneous Electrodes for Recording Purposes are the first device type guidance documents release by FDA for the expanded Abbreviated Premarket Notification 510(k) Program.  This pathway sets the stage for device manufacturers to use performance measures in place of direct comparisons against predicate devices. The direct use of performance measures for devices that qualify for the abbreviated 510(k) Safety and Performance Based Pathway is expected provide manufacturers with substantial savings of both time and resources.  


The Safety and Performance Based Pathway, as an expansion of the Abbreviated 510(k) pathway announced by FDA in February of 2019, is designed to be used for well understood device types. Follow the link below for specific information on the program. 

Safety and Performance Based Pathway 

Certain class II moderate risk devices are able to use the Safety and Performance Based Pathway to gain clearance for marketing if they can demonstrate that they meet FDA’s modern performance criteria. Under these criteria, the device must be demonstrated to be as safe and effective as other devices of the same type that are already on the market that conform to the FDA-identified performance criteria. The Safety and Performance Pathway is appropriate when FDA has determined: 

  • The new device has the same indications for use as, and technological characteristics that do not raise different questions of safety and effectiveness than, the identified predicate; and 
  • The new device meets all the FDA-identified performance criteria. 

A guidance document was released in September 2019 that describes the optional pathway and provides “FDA’s current thinking on expanding the concept of the Abbreviated 510(k) program for demonstrating substantial equivalence for premarket notification (510(k)) submissions.”  

Safety and Safety and Performance Based Pathway 

Guidance for Industry and Food and Drug Administration Staff 

This newest expansion of the Abbreviated 510(k) Program provides device manufacturers the option to use the performance criteria proposed in the guidance to support substantial equivalence in place of direct comparison of performance of the device to that of a predicated device.  

First Device Type Guidance Documents 

On August 13, 2020, the FDA issued the first final guidance documents for Conventional Foley Catheters and Cutaneous Electrodes for Recording Purposes as part of the FDAs commitment to “strengthen and modernize the 510(k) program.”  

Safety and Performance Based Pathway guidance documents are expected to be released by FDA for each device type that qualifies. The first 2 guidance documents for conventional Foley catheters and cutaneous electrodes have similar overall outlines: 

  1. Introduction 
  1. Scope/Device Description 
  • Intended Use / Indications for Use 
  • Device Design Characteristics 
  1. Testing Performance Criteria 
  • Device Testing / Device Characterization 
  • Sterilization and Reprocessing Validations (if applicable) 

The Testing Performance Criteria section clarifies that FDA is asking for a summary of all tests evaluated in addition to the Declaration of Conformity (DoC) for the test specified to “ensure the performance criteria outline in this guidance document remains contemporary and takes into account relevant data from recent clearances.” Furthermore, test information such as results summary, test protocols, or complete test reports need to be submitted as part of the 510(k) as described in the Safety and Performance Based Pathway. 

Future Guidance Documents 

FDA lists 4 additional Safety and Performance Based Pathway guidance document for device types that are currently in draft guidance form and the final guidance’s are expected to roll out in the near future. 

The FDA is encouraging industry to become involved in the process. Industry can and should suggest additional device types in which there are comprehensive FDA-recognized consensus standards that correspond with the FDA-identified performance criteria in order to reap the benefits of this Abbreviated 510(k) pathway. In addition, FDA is encouraging industry and other stakeholders to submit evidence-based suggestions on what performance criteria should be for eligible device types. FDA plans to continue to issue draft and subsequent final guidance’s for the Safety and Performance Based Pathway. 

Need Expert Medical Writers for Submission Support? 

Criterion Edge has an experienced team that can provide support for your organization’s risk to benefit analysis and risk management reports. Feel free to reach out to us for a free consult.  

FDA’s tips on how to improve Premarket submissions applications and the pending release of the electronic submission program, eSTAR, can be found in our previous post.   

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