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 

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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 20, 2020

[FEATURED] Firms With Rocky MDR Compliance Histories Shut Out Of FDA Adverse Event Program

The US agency has updated its Medical Device Reporting website with information on which products qualify for its Voluntary Malfunction Summary Reporting program for adverse events, and which don’t.

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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 22, 2020

[FEATURED] FDA Updated Its eMDR System. Here’s What You Need To Know When Submitting Adverse Events

Executive Summary

The US agency has completed planned modifications to its electronic Medical Device Reporting system – and added an extra field for MDR exemption numbers.

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July 20, 2020

[FEATURED] FDA To Makers Of EUA Devices: Don’t Forget To Report Adverse Events

Manufacturers of devices granted emergency use authorization (EUA) status during the COVID-19 crisis are fully responsible for filing any adverse events about the products to the FDA, the US agency says on a new FAQ page.

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