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.  

Background 

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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November 20, 2019

[FEATURED] It’s Raining Guidance Docs: FDA Expands Abbreviated 510(k) Program

In a new final guidance, the US agency has expanded its abbreviated 510(k) program for certain devices to look beyond conformity assessments and instead look at performance criteria. Alongside the guidance, the agency also released four draft guidances for devices it is considering clearing under the new pathway.

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