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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October 22, 2020

[FREE WEBINAR] Hidden Traps That Will Derail Your CER: Answer these critical questions before you start writing

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

You have planned a time to complete your Clinical Evaluation Reports to meet the upcoming MDR deadline, but when your team sits down to write, will they have everything they need to complete the job?

As we all know, the MDR has significantly increased both the quality and quantity of inputs needed to complete a CER. This takes more up-front planning than the reports have in the past, and the last thing you want to do is torpedo your writing project timeline by not having everything your team needs when that project begins.

Based on our experiences with clients both large and small, our President, Laurie Mitchell, will share with you some of the biggest issues we have discovered when starting an MDR CER project. And Laurie will also reveal some of the most successful strategies in addressing these issues, up-front and early.

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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October 12, 2020

FDA Experts Provide Tips to Eliminate eCopy Holds for Premarket Submission Applications: FDA Touts eSTAR Development

Author: Suzanne Broussard, PhD 

Up to 7% of premarket submissions are placed on eCopy Hold. At a recent public workshop, FDA experts provided multiple tips to device manufacturers to avoid this trap and get their submission accepted the first time. Although the workshop focused on spinal device premarket reviews, most of the tips are relevant for all device manufacturers submitting premarket submission applications.  

Sometime in the near future, FDA will roll out this new electronic Submission Template and Resource (eSTAR) portal making eCopy obsolete. However, FDA urges manufacturers to take advantage of its current guidelines and resources to make their documents as clean as possible and ready for review right now.  

The currently used eCopy is a digital version of the traditional paper submission that reviewers interact with, like a paper copy. Failure to meet all the technical requirements of eCopy results in the eCopy Hold, which resets the review clock upon resubmission and can be costly to manufacturers.  

According to Zane Wyatt, Premarket Tools and Template Developer for FDAs Office of Regulatory Programs, the 7% of FDAs premarket submissions placed on eCopy Hold could have been avoided by taking the following steps.

1. Use the newest eCopy guidance document published April 27, 2020: 

eCopy Program for Medical Device Submissions – Guidance for Industry and Food and Drug Administration Staff 

Note that the eCopy electronic version of your medical device submission created and submitted on a CD, DVD or flash drive does not increase or decrease the type or amount of data included in a submission to support clearance or approval.  

The FDA processes the eCopy onto a secure internal database that has upload restrictions, thus the strict technical requirements. If the submission fails the technical requirement for intake and archival, the submission is placed on eCopy Hold until all the technical requirements are met that allow the reviewers access to the document. 

The eCopy guidance document provides details on: 

  • Submission types that require an eCopy 
    • Premarket notification submissions (510(k)), including third party 510(k)s
    • Evaluation of automatic class III designation petitions (de novos)
    • Premarket approval applications (PMAs), including Transitional PMAs
    • Modular PMAs 
    • Product development protocols (PDPs)
    • Investigational device exemptions (IDE) submissions 
    • Humanitarian device exemptions (HDEs) submissions 
    • Emergency Use Authorizations (EUAs) 
    • Certain investigational new drug applications (INDs)
    • Certain biologics license applications (BLAs)
    • Q-submissions
  • Other submission types not subject to the eCopy legislation for which eCopies may be submitted 
  • Processing steps for eCopy 
  • Devices regulated by CBER 
  • Technical Standards of the eCopies 
    • Document content (original, supplement, amendment, or report) 
    • Create company letter head per specific requirements 
    • Determine volume-based or non-volume-based structure 
    • Specifics on PDF requirements (naming convention, root level, Adobe Acrobat version, no embedded attachments, no security settings, size limit of 50MB) 
    • Use of non-PDFs 
    • Package preparation and mailing to the Document Control Center (CCC) 

2. Consider using the FDAs eSubmitter-eCopies Tool (voluntary) to format your eCopy content. 

The eCopy Validation tool is a downloadable software that can help compile all documents into the correct format, however, the electronic documents still need to be physically sent to the FDA document center. 

3. Use eCopy Validation on the FDA website using the most recent version (July 20, 2018). 

FDA Tip to Applicants: 
“It is recommended that you use the eCopy Validation Module to check the final eCopy on the CD, DVD, or flash drive before submitting it to the FDA in order to identify any errors or hidden files that may cause an eCopy to fail the eCopy Loader used by FDA. 

(eSTAR) – 510(k) submissions through eSTAR are currently in a pilot program. The dynamic PDF submission template will provide many advantages including: 

  • Content mirrors the reviewer’s Smart Template 
  • Integration and elimination of guidance documents 
  • Automation and Integrated Databases 
  • Guides 
  • No special software install or training 
  • Works on mobile and Macs, and is free to use 

Employing these three tips to your premarket submission could save your organization valuable time in the review process with regulatory authorities. FDA is moving towards a fully electronic submission that is dynamic, responsive, and flexible in its development of eSTAR. Until eSTAR is fully available for all premarket submissions, these tips from FDA experts may come in handy.  

Preparing all the technical documents required for premarket submission will require much more effort. 

Criterion Edge’s team of medical writers are experts at preparing the technical, safety, and regulatory documents required to get to the premarket submission phase. Feel free to reach out to us for a free consult.  

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September 28, 2020

Notified Bodies Received New Guidance from MDCG on the Use of MDSAP Audit Reports for MDR and IVDR

Author: Dr. Suzanne Broussard

Medical device manufacturers received clarification on how the European Commission’s Medical Device Coordination Group (MDCG) will allow Notified Bodies (NBs) to use Medical Device Single Audit Program (MDSAP) audit reports. The punch line of the MDCG 20-14 guidance document published in August 2020 is that NBs can possibly “take into account the scope and outputs of manufacturers’ recent MDSAP audit reports as an input for developing surveillance audit programs.”    

MDCG stresses that the Medical Device Regulations (MDR) and In Vitro Device Regulations (IVDR) remain applicable in their entirety. Surveillance audits are mandated by law, as is their frequency, and the EU auditor’s competencies. Therefore, the “use of MDSAP audit reports is possible only where MDSAP audits covers similar of equivalent MDR/IVDR requirements.”  

Canada mandates the use of MDSAP audits, and 4 other countries allow their use.

MDSAP offers a harmonized auditing program to medical device manufacturers in Australia, Brazil, Canada, Japan, and US. See our previous posts for more information on MDSAP, what it is, what to expect, and tips to ace the MDSAP audit.

Are You a Global Medical Device Manufacturer That Is Tired Of Multiple Regulatory Audits? Consider Transitioning To The MDSAP Single Audit

What To Expect During An MDSAP Audit

9 Tips To Ace The MDSAP The First Time

The MDCG 20-14 guidance now allows NBs in the European Union to take into account the manufacturers’ recent MDSAP audit reports’ scope and outputs as input for developing the surveillance audit program that defines more precisely the manner of the surveillance audit. Several examples are provided in which conformity of a positive quality management system through MDSAP might lead to a reduction of aspects already covered by MDSAP audit reports.  

Non-exhaustive list of examples (in alphabetical order): 

  • Clinical evaluation/performance evaluation process (including post-market clinical/performance follow-up), 
  • EU authorized representative contractual provisions, 
  • EU UDI assignment with the quality management system, 
  • Manufacturer financial coverage in respect of potential liability, 
  • Person responsible for regulatory compliance qualification and role,  
  • Records control, 
  • System for risk management, 
  • Vigilance and post market surveillance activities, including the associated corrective actions and preventative actions. 

The focused surveillance may allow NBs to specify MDR/IVDR requirements either not covered or only partially covered by the MDSAP audit report. Comparablyany non-conformities identified in a recent MDSAP audit report will likely trigger NB attention to those aspects in the MDR/IVDR surveillance audits. 

The MDCG 20-14 guidance clearly states that the NBs are fully responsible for their decisions as to the use and to what extent they use the MDSAP audit reports. Note that MDSAP audit reports can only be presented to the NB for consideration during a regular surveillance audit. Manufacturers cannot use MDSAP for the MDR/IVDR initial quality management audits or unannounced audits.   

The MDCG 20-14 also includes 2 Annexes.  

Part I – Explanation of relevant information in MDSAP audit reports 

Part II – Examples on how to correlations between MDR requirements to sections of MDSAP audit reports may be established.  

The MDSAP was developed by the International Medical Device Regulators Forum (IMDRF) to provide improved medical device safety and oversight using a global approach to auditing and monitoring, and now the MDCG 20-14 guidance document provides NBs and medical device manufacturers with guidelines as to how MDSAP fits into the medical device regulations MDR and IVDR that will be in full application in the near future.  

If your organization needs guidance, or just some extra support, on preparing technical documents for MDR, IVDR or, an MDSAP audit, Criterion Edge has experienced medical writers in a wide variety of documents including medical affairs, clinical sciences, technical, safety, and regulatory.  

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