• Login
    • Advanced search
    • Title
    • Channel
    • Module
  • Home
  • Industry
    •  

      • Aerospace, Defense, and Government Services
      • Automotive
      • Consumer
      • Manufacturing and Industrials
      • Education
      • Energy and Natural Resources
      • Financial Institutions
    •  

      • Insurance
      • Life Sciences and Health Care
      • Private Capital
      • Real Estate
      • Sports, Media and Entertainment
      • Technology and Telecoms
      • Transport and Logistics
  • Practice
    • Corporate & Finance

      • Banking and Loan Finance
      • Business Restructuring and Insolvency
      • Capital Markets
      • Corporate Governance and Public Company Representation
      • Digital Assets and Blockchain
      • Infrastructure, Energy, Resources, and Projects
      • Leveraged and Acquisition Finance
      • Mergers and Acquisitions
      • Pensions
      • Private Equity, Venture Capital and Investment Funds
      • Real Estate
      • Real Estate Investment Trusts (REITs)
      • Tax
      • Transfer Pricing
    • Global Regulatory

      • Administrative and Public Law
      • Antitrust and Competition
      • Communications, Internet, and Media
      • Education
      • Energy Regulatory
      • Environment and Natural Resources
      • Financial Services
      • Food Law
      • Gaming Law
      • Government Contracts and Public Procurement
      • Government Relations and Public Affairs
      • Health
      • Immigration
      • International Trade and Investment
      • Medical Device and Technology Regulatory
      • New Nuclear
      • Pharmaceuticals and Biotechnology Regulatory
      • Privacy and Cybersecurity
      • Space and Satellite
      • Strategic Operations, Agreements and Regulation
      • Transportation Regulatory
    • Intellectual Property

      • Copyright
      • Designs
      • Domain Names
      • IP and Technology Transactions
      • IP Enforcement
      • Patents
      • Trade Secrets and Confidential Know-how
      • Trademarks and Brands
      • Unfair Competition
    • Litigation, Arbitration, and Employment

      • Business and Human Rights
      • Construction and Engineering
      • Corporate and Securities Litigation
      • Employment
      • International Arbitration
      • Investigations, White Collar, and Fraud
      • Products Law
      • Risks, Disputes, and Litigation
  • Comparative guides
  • Engage Premium
  • Login
  • Register
Hogan Lovells Engage 5.7.13
      • Title
      • Channel
      • Module
    • Hit ENTER to search in content
    • Advanced search
    • Login
  • Home
  • Industry
    •  

      • Aerospace, Defense, and Government Services
      • Automotive
      • Consumer
      • Manufacturing and Industrials
      • Education
      • Energy and Natural Resources
      • Financial Institutions
    •  

      • Insurance
      • Life Sciences and Health Care
      • Private Capital
      • Real Estate
      • Sports, Media and Entertainment
      • Technology and Telecoms
      • Transport and Logistics
  • Practice
    • Corporate & Finance

      • Banking and Loan Finance
      • Business Restructuring and Insolvency
      • Capital Markets
      • Corporate Governance and Public Company Representation
      • Digital Assets and Blockchain
      • Infrastructure, Energy, Resources, and Projects
      • Leveraged and Acquisition Finance
      • Mergers and Acquisitions
      • Pensions
      • Private Equity, Venture Capital and Investment Funds
      • Real Estate
      • Real Estate Investment Trusts (REITs)
      • Tax
      • Transfer Pricing
    • Global Regulatory

      • Administrative and Public Law
      • Antitrust and Competition
      • Communications, Internet, and Media
      • Education
      • Energy Regulatory
      • Environment and Natural Resources
      • Financial Services
      • Food Law
      • Gaming Law
      • Government Contracts and Public Procurement
      • Government Relations and Public Affairs
      • Health
      • Immigration
      • International Trade and Investment
      • Medical Device and Technology Regulatory
      • New Nuclear
      • Pharmaceuticals and Biotechnology Regulatory
      • Privacy and Cybersecurity
      • Space and Satellite
      • Strategic Operations, Agreements and Regulation
      • Transportation Regulatory
    • Intellectual Property

      • Copyright
      • Designs
      • Domain Names
      • IP and Technology Transactions
      • IP Enforcement
      • Patents
      • Trade Secrets and Confidential Know-how
      • Trademarks and Brands
      • Unfair Competition
    • Litigation, Arbitration, and Employment

      • Business and Human Rights
      • Construction and Engineering
      • Corporate and Securities Litigation
      • Employment
      • International Arbitration
      • Investigations, White Collar, and Fraud
      • Products Law
      • Risks, Disputes, and Litigation
  • Comparative guides
  • Engage Premium
  • Login
  • Register
  1. News
  2. “Remanufacturing” or “Servicing”? New FDA guidance clarifies distinction for medical devices

“Remanufacturing” or “Servicing”? New FDA guidance clarifies distinction for medical devices

22 June 2021
    • Share by email
    • Share on
    • Twitter
    • LinkedIn
    • Get link
    • Get QR Code
    • Download
    • Print

On June 18, 2021, the U.S. Food and Drug Administration (FDA) issued the draft guidance “Remanufacturing of Medical Devices,” which aims to help clarify the point when manipulation or repair of a medical device becomes “remanufacturing” as opposed to “servicing,” with this designation carrying significant regulatory impact. Simultaneously, FDA issued a discussion paper on cybersecurity and servicing of medical devices. FDA will accept comments on both publications until August 17, and we have addressed these new documents below. Together these documents provide some additional clarity around an area that has been murky for years – the roles and obligations of third parties who handle, service, reprocess, refurbish, remanufacturer, and perform other functions on medical devices.

Index
  1. Six guiding principles
    1. Significant change
    2. Documenting a change to a medical device
    3. Changes to software
    4. Labeling for reuse
    5. Implications
    6. Cybersecurity discussion paper

Six guiding principles

Remanufacturing is “the processing, conditioning, renovating, repackaging, restoring, or any other act done to a finished device that significantly changes the finished device’s performance or safety specifications, or intended use.” 21 CFR 820.3(w). In contrast, the draft guidance defines servicing as “ the repair and/or preventive or routine maintenance of one or more parts in a finished device, after distribution, for purposes of returning it to the safety and performance specifications established by the OEM [original equipment manufacturer] and to meet its original intended use.” The draft guidance points out that this distinction does not turn on an entity’s self-identified designation as a “servicer” or “remanufacturer,” but instead focuses on the specific activities an entity performs on a particular device and the impact of that activity on the device.

In the draft guidance, FDA recommends following six guiding principles when determining whether activities are “remanufacturing”:

  1. Assess whether there is a change to the intended use;

  2. Determine whether the activities, individually and cumulatively, “significantly change” the safety or performance specifications of a finished device;

  3. Evaluate whether any changes to a device require a new marketing submission;

  4. Assess component/part/material dimensional and performance specifications;

  5. Employ a risk-based approach; and

  6. Adequately document decision-making.

“Significant change”

FDA says it will deem a product to be remanufactured when there is a “significant change,” and the draft guidance emphasizes that FDA considers a “significant change” to device performance or safety specifications to be one that, based on verification and validation testing and/or a risk-based assessment, results in a finished device that is outside the OEM’s performance or safety specifications or introduces new risks or significantly modifies existing risks, such as changes to the device’s sterilization methods, reprocessing instructions, control mechanism, operating principle, or energy type.

The draft guidance offers the following flowchart to help determine whether activities performed are likely to be considered remanufacturing:

As noted in Figure 1, the flow chart is only intended to be used after a determination is made that there is no significant change to the device’s intended use or to its sterilization methods, reprocessing instructions, controls mechanism, operating principle, or energy type; any of which would indicate the occurrence of a remanufacturing activity. If that determination is made, the flowchart may then be helpful in determining if the activity is still likely to be considered “remanufacturing.”.

FDA does not recommend evaluation with Figure 1 when an activity is performed on behalf of or otherwise explicitly authorized by the OEM and the activity returns the legally marketed device to its original performance and safety specifications and intended use. FDA believes such activities would likely not be remanufacturing, and such determination should be adequately documented.

Documenting a change to a medical device

The draft guidance also focuses on the importance of medical device companies preparing documentation in a way that an FDA investigator or other third party can understand what changes were made to a product, as well as the rationale underlying the company’s conclusion on whether those changes should be deemed “remanufacturing.” FDA recommends that the documentation include, at a minimum, the following:

  • Product name (including model number and serial number, if applicable);
  • Date of activities performed, assessment, and determination;
  • Description of device;
  • Description of activities to be performed, including documentation of components/parts/materials involved;
  • Determination of whether the activity is remanufacturing (we recommend using the applicable sections of this guidance);
  • Reference to related documents supporting the decision-making process; and,
  • Signature(s).

The guidance also contains an appendix that provides examples of proper documentation.

Changes to software

The guidance indicates that Figure 1 and its accompanying text should not be applied to changes involving software and goes on to state that many software changes are likely remanufacturing because of their impact on a product’s software architecture, software requirements specifications, unresolved anomalies, and other key characteristics. Because the probability of a software failure cannot be determined using traditional statistical methods, the guidance recommends applying an alternative software specific analysis when evaluating whether an activity constitutes remanufacturing. FDA has identified certain activities performed on software that are likely not remanufacturing because “they generally do not significantly change the performance or safety specifications of the device”:

  • Activities performed on behalf of or otherwise explicitly authorized by the OEM that return the legally marketed device to its performance and safety specifications, and intended use;
  • Implementing OEM provided updates and upgrades;
  • Running software-based hardware diagnostics;
  • Assessing for viruses, malware, and other cybersecurity related issues;
  • Reinstalling OEM software to restore original performance and safety specifications;
  • Reverting software to a previous configuration;
  • Installing cybersecurity updates that are authorized by the OEM;
  • Turning on or off connectivity features (e.g., Wi-Fi and Bluetooth connections) consistent with OEM intended use;
  • Performing data backup and recovery operations;
  • Assessing software inventory;
  • Collecting system logs;
  • Managing user accounts; and
  • Accessing diagnostic and repair information.

Yet, the draft guidance notes that “[m]any software changes are likely remanufacturing because of their impact on a product’s software architecture, software requirements specifications, unresolved anomalies and other key characteristics” (emphasis added). The guidance also states that software changes that significantly modify a device’s intended use would be considered “remanufacturing.”

Labeling for reuse

FDA warns in the draft guidance that unintentional remanufacturing can occur when entities do not have the instructions necessary to return a device to its original performance and safety specifications. In addition, the “lack of adequate servicing instructions can also create challenges in the availability of quality, safe, and effective devices,” the agency writes.

Accordingly, the draft guidance encourages OEMs to provide servicing instructions that facilitate routine maintenance and repair of their reusable devices, recommending that the labeling of reusable devices include the following information, as applicable:

  • A description of the key performance and safety specifications;
  • Critical technical or functional specifications, including:
    • Physical dimensions;
    • Electrical characteristics, including batteries (e.g., chemistry, amperage, voltage, rechargeability), internal fuses, and power supply (e.g., voltage, amperage, frequency); and
    • Device-specific performance specifications (e.g., flow rate accuracy or range, humidity, temperature, wavelength).
  • The recommended maintenance activities and schedule;
  • Recommended routine testing and acceptance criteria to confirm that the device remains within its performance and safety specifications;
  • A description of error codes, alerts, and alarm features on the device;
  • Precautions and warnings relevant to servicing the device; and
  • Version number and release date of software.

Implications

Where an entity is deemed to be “remanufacturing,” that activity triggers consideration of all of the obligations of a medical device manufacturer, including, for example:

  • Whether a new marketing submission is required;

  • MDR reporting (for both the remanufacturer, and the OEM if they become aware of a reportable event);

  • Registration and listing;

  • QSR compliance;

  • Removals or corrections obligations and reporting; and

  • General adulteration and misbranding prohibitions

Cybersecurity discussion paper

Simultaneously with the draft guidance, FDA published a related discussion paper that covers four cybersecurity issues unique to servicing of medical devices by entities who are not the OEMs: (1) privileged access; (2) identification of cybersecurity vulnerabilities and incidents; (3) prevention and mitigation of cybersecurity vulnerabilities; and (4) product lifecycle challenges and opportunities. FDA is seeking input on each of these topics, and on the following questions:

  • What are the cybersecurity challenges and opportunities associated with the servicing of medical devices?

  • Are the four areas identified in this white paper the correct cybersecurity priority issues to address in the servicing of medical devices? If not, which areas should be the focus?

  • How can entities that service medical devices contribute to strengthening the cybersecurity of medical devices?

 

On July 27, the FDA will also host a webinar for stakeholders interested in learning more about the guidance and discussion paper. FDA will accept comments on both until August 17, 2021.

If you may wish to submit a comment, or have any questions on remanufacturing of medical devices, please contact any of the authors of this alert or the Hogan Lovells attorney with whom you regularly work.

 

Authored by Ted Wilson, Jodi K. Scott, Wil Henderson, and Mike Heyl

Contacts
Ted Wilson
Partner
Washington, D.C.
Jodi Scott
Partner
Denver
Michael Heyl
Partner
Washington, D.C.
Wil Henderson
Senior Associate
Denver
Index
  1. Six guiding principles
    1. Significant change
    2. Documenting a change to a medical device
    3. Changes to software
    4. Labeling for reuse
    5. Implications
    6. Cybersecurity discussion paper
Related Materials
RobotAndHand

Five highlights from FDA’s new AI device regulation Action Plan

GO-Digital Health_Fitness tracker

FDA Pre-Cert update: “more work needed” to refine Streamlined Review Framework

PLEASE DO NOT USE: DUP_Medical Devices_ Doctor Viewing Computer Image

FDA explains how EUA medical devices can electronically comply with AE reporting requirements

LAE, PublicLaw_March_2017_lawyer_gavel_1135769117

Federal court limits FDA discretion in “drug” vs. “device” classification

GO-Digital Health_Fitness tracker

FDA finalizes policy on multi-function medical devices’ premarket submissions

GO-Pharma and Biotech reg law-microscope

First company receives FDA violation notice for ClinicalTrials.gov submission omission

COVID

COVID-19 Report for Life Sciences and Health Care Companies (June 2021)

GO_Medical Devices_Manufacturing_health

HHS withdraws proposal to exempt 84 medical device types from FDA 510(k) process

GO-Environment-sea-shutterstock_305363720

New FDA draft guidance on voluntary recalls highlights importance of recall initiation plans

PLEASE DO NOT USE: DUP_Medical Devices_ Doctor Viewing Computer Image

Reforms to software-based medical devices take effect this week

Artificial Intelligence

Looking ahead to 2021: AI – A brave new world?

Keywords remanufacturing, servicing, food and drug administration, fda, cybersecurity, discussion paper, processing, conditioning, renovating, repackaging, restoring, documentation, software
Languages English
Topics Medical Device Software and Cybersecurity, Advertising and Promotion of Medical Devices, In Vitro Diagnostics, State Licensing of Medical Device, Regulatory Inspections and QSR/ISO 13485, Premarket Strategy, Submissions, and Review, Postmarket Performance, Combination Products, Life Science Government Enforcement and Compliance, Digital Health
Countries United States
Delete Comment ?

Are you sure want to delete comment ?

Get link
Embed
Share by email
Get QR Code

Scan this QR Code to share this content

  • Contact us
  • Disclaimer
  • Privacy
  • Cookies
  • Legal Notices
  • Terms of Use

 

This website is operated by Hogan Lovells International LLP, whose registered office is at Atlantic House, Holborn Viaduct, London, EC1A 2FG. For further details of Hogan Lovells International LLP and the international legal practice that comprises Hogan Lovells International LLP, Hogan Lovells US LLP and their affiliated businesses ("Hogan Lovells"), please see our Legal Notices page. © 2022 Hogan Lovells.

Attorney advertising. Prior results do not guarantee a similar outcome.

Thomson Reuters HighQ Logo
© 2023 Hogan Lovells | Privacy Policy | Terms of Service