January 5, 2021

FDA Provides Guidance on the Regulation of Multiple Function Products with Some Functions that Fall Outside the Medical Device Umbrella

Author: Suzanne Broussard, PhD 

The increasing number and complexity of medical devices with several functions prompted FDA to provide medical device manufacturers with premarket and postmarket regulatory guidance. In a nutshell, FDA states that it shall not regulate non-device functions of a product with multiple functions – but can consider the impact of non-device functions on the device functions. The guidance identifies the principles and premarket review practices, postmarket requirements, and multiple examples of the application of the policy. 

The term “multiple function” device was first officially addressed by FDA in the 21st Century Cures Act Section 3060 that amended the Federal Food, Drug, and Cosmetic Act (FD&C Act). The guidance amended the definition of “device” removing certain software functions (medical and decision software support) and clarifies which software functions (analyze or interpret medical data) remain under FDA’s oversight.    

The Multiple Function Device Products: Policy and Considerations Guidance for Industry and Food and Drug Administration extends that policy to the assessment of all multiple function device products, whether those functions are hardware-based, software-based, or both.  

Guidance Scope 

The guidance document is intended to clarify FDA’s policy approach to all multiple function devices, considerations for the design and risks of multiple function device products, and impact assessment of non-device software functions or “other functions” on safety and effectiveness. Furthermore, the guidance provides recommendations on the premarket submission content FDA expects for a device function that is part of a multiple device product. Modifications and postmarket requirements are also addressed. 

The policy is risk based with a functionally focused approach to software that is platform independent. The regulation is narrowly tailored to the device’s risk based on the function with the ultimate intent to protect patient safety. 

In the guidance, FDA clearly delineates “other functions” and device function-under review.  

Definitions 

To begin, FDA defines function as a “distinct purpose of the product” and further clarifies that function could be the intended use or a subset of the intended use of the product. For example, a device with the intended use of storing, transferring, and analyzing data has three functions while a device with the intended use of analyzing data has only one.  

“Other function” is considered a function that: 

  • Does not meet the definition of device; 
  • Meets the definition of device, but is not subject to premarket review (e.g., 510(k)-exempt); or 
  • Meets the definition of device, but for which FDA has expressed its intent not to enforce compliance with applicable regulatory controls.  

Multiple function devices are comprised of functions that are subject to FDA’s regulatory oversight and “other functions” that are not.  

Device function-under review is defined as a function for which FDA is conducting premarket review. 

Policy: Premarket Review Considerations for Multiple Function Device Products 

The guidance clarifies that while “other functions” that are part of a multiple-function device are not the subject of FDA review, FDA may assess the impact of “other functions” when conducting the premarket review to determine the devices safety and effectiveness.  

Other Functions Should be Separated in Design and Implementation 

FDA considers the separation of functions of the device-under-review from “other functions” important for risk control. Ideally, the separation occurs early in the design with a higher degree of separation allowing for easier review of the independent safety and effectiveness of the devices function.  

Making architecture decisions early in the design cycle that facilitate risk control especially allow for the evaluation of optimal separation and support segregation of: 

  • Logic  
  • Architecture 
  • Code 
  • Data partitioning 

This separation is considered “especially important when considering cyber security risk and mitigations.” 

Risk Analysis Needs to Consider the Impact of Other Functions 

The guidance outlines the following as critical for manufacturers to consider regarding the impact of other functions. 

  • Role of the “other function” in the devices function-under-reviewperformance
  • Limitations of the device function-under-review when using the “other function:” 
  • Developing appropriate hardware and software resources specifications(s) for the product with multiple functions to ensure minimal impact of the “other function” on the performance of the device functions-under-review; 
  • How to ensure appropriate actions are taken by the end user when using the device function-under-review with the “other functions;” and 
  • Identification, evaluation, and mitigation of any additional risks, including cybersecurity risks, in the device-functions-under-review when used in combination with the “other function.” 

When separation cannot be achieved, the interconnectedness and interdependencies of the devices function and “other function” needs to be included in the hazard analysis. Furthermore, an appropriate control must be created.  

Assessing the Impact of “Other Functions” on the Device Function-Under-Review 

FDA is clear on how it intends to assess the impact of “other functions” and provides a flow chart to guide manufacturers through the assessment.  

Manufacturers need to conduct a risk assessment to determine if the “other functions” impact the safety and effectiveness of the device under review. The other functions could act to have a positive effect or an adverse effect.  

A two-step process summarizes the premarket assessment.  

First, is there an impact on the Safety and Effectiveness of the device function-under review as a result of the “other function?” If yes, could this be a negative impact, meaning an increased risk or an adverse effect on performance of the device function under review?  

Positive impact assessments must include the beneficial impact of “other functions” on the device-under-review when the device is operating as intended. In addition, the manufacturer must confirm that the “other functions” do not impart an adverse impact if the device-under-review fails to operate as intended. 

Negative impact assessments must identify the potential for an increased risk and/or adverse effect on performance “due to the combination of the other function with the device-under-review. 

“Other functions” that impact the device under review must be evaluated and included in the hazard analysis.  

Manufacturers need only added other functions to the submission if the positive effects are represented on the device label – a labeled positive impact – or if it may negatively impact the device that is under review.  

Examples of Multiple Function Devices  

The FDA provides 7 examples of multiple function device products in Appendix 1. The examples provide a description of the product, product functions (see list below), description of the impact of the “other function” on the device function-under-review and an explanation of the impact assessment.  

Below is a list of the hypothetical example device products. See the guidance for details on impact assessment.  

  • Skin cancer detection software application 
    • Device function under review: 
      • Software app that detects skin cancer 
    • “Other function:” 
      • Smart phone computing platform 
      • Camera on the computing platform 
  • Hand-held coagulation device 
    • Device function under review: 
      • Hand help coagulation instrument 
      • Coagulation (prothrombin time) test 
    • “Other function:” 
      • Docking station 
      • Interface to transmit the data to the HIS 
  • Traumatic brain injury determination 
    • Device function under review: 
      • Collection and recording of EEG signals 
      • Analyzing EEG signals and diagnosing TBI 
      • Presentation of results 
    • “Other function:” 
      • General use computing platform 
      • Electronic administration of questionnaire 
  • Pain treatment app 
    • Device function under review: 
      • Electronic Nerve Stimulation as a treatment for pain 
      • App used to control the level of stimulation 
    • “Other function:” 
      • Mobil platform Bluetooth transceiver and connectivity 
  • Transmission of vital sign measures to an Electronic Health Record (HER) 
    • Device function under review: 
      • Vital signs acquisition 
    • “Other function:” 
      • Transmission software for sending data to the HER system 
      • Wi-Fi card  
  • Energy-delivering device with optional app (MDDS) 
    • Device function under review: 
      • Energy-delivering aesthetic device 
    • “Other function:” 
      • Mobil app that integrates with device and transfers treatment parameter data (e.g., number of treatments, treatment parameters) to a cloud-based storage – no real-time transmission is allowed 
      • Smart phone computing platform 
  • Pulsed ultrasound and biopsy needle guide kit 
    • Device function under review: 
      • General purpose diagnostic ultrasound system 
      • Biopsy needle tracking functionality 
    • “Other function:” 
      • 510(k)-exempt needle guide kit 

Postmarket Guidance 

The guidance applies to post-market regulations and implicitly states that device functions must comply with design control requirements and expectations surrounding adverse event reporting.  

FDA reinforced its position that it does not intend to “enforce general control requirements for device functions for which FDA has expressed its intention to not enforce applicable regulatory controls at this time.” 

Multiple function device products that have undergone modifications of the “other function” must be assessed to determine if the change has the potential to significantly impact the safety or effectiveness of the device function that was the subject of FDA review.  

This guidance document was written to clarify current regulations as well as to promote innovation and patient engagement with digital health products.  

To catch up on FDA’s newest premarket guidance documents see our previous post on Nuances of Using the Safety and Performance Pathway for Submitting a 510(k) for Certain Device Types and FDA Experts Provide Tips to Eliminate eCopy Holds for Premarket Submission Applications: FDA Touts eSTAR Development. 


Document Experts 

The generation of technical documents that are required for medical device premarket approval requires time and expertise. Consider increases in your company’s efficiencies by working with a team of medical writers that are document experts. At Criterion Edge, we take pride in teaming up with industry experts to provide high quality support. Please reach out to us 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.  

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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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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