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US FDA Guidance on IFUs for Medical Devices

In the USA, requirements for IFU are put forward by the Code of Federal Regulations (CFR). 21 CFR Part 800-1299  deal with medical devices while requirements of 21 CFR Part 809.1 apply to “Labeling of in-vitro diagnostic products.”

Labeling – Part 801

General Labeling Provisions – Subpart A

Medical Devices; Adequate Directions for Use Section 801.5

FDA has published a document “Guidance on Medical Device Patient Labelling.” to support the instructions given in section 801.5. The document serves as a supporting document by providing further guidance about the instructions given in section 801.5 of General Labeling Provisions. Regarding the IFU, lets quote the section 801.5:

“Adequate directions for use mean directions under which the layman can use a device safely and for the purposes for which it is intended. Section 801.4 defines intended use. Directions for use may be inadequate because of, among other reasons, omission, in whole or in part, or incorrect specification of:

(a) Statements of all conditions, purposes, or uses for which such device is intended, including conditions, purposes, or uses for which it is prescribed, recommended, or suggested in its oral, written, printed, or graphic advertising, and conditions, purposes, or uses for which the device is commonly used; except that such statements shall not refer to conditions, uses, or purposes for which the device can be safely used only under the supervision of a practitioner licensed by law and for which it is advertised solely to such practitioner.

(b) Quantity of dose, including usual quantities for each of the uses for which it is intended and usual quantities for persons of different ages and different physical conditions.

(c) Frequency of administration or application.

(d) Duration of administration or application.

(e) Time of administration or application, in relation to time of meals, time of onset of symptoms, or other time factors.

(f) Route or method of administration or application.

(g) Preparation for use, i.e., adjustment of temperature, or other manipulation or process.”

Instructions Given in “Guidance on Medical Device Patient Labeling” Regarding Instructions for Use

Risk-Benefit Information & IFU

The medical device manufacturer is allowed to include benefit/risk analysis along with IFU.

Instructions to Develop IFUs for Patients & Laypersons

In case patients and/or their lay caregivers need to

  • Work on maintaining the medical device
  • Perform monitoring and reporting regarding operation or output of the device
  • Explain to others regarding device’s working
  • Explain patient’s medical condition to others
  • Get information regarding changing their lifestyles or care regimens so that they can make the proper use of the device for their health
  • Know about the correct disposal method of the medical device, then the manufacturer should consider developing IFUs for such patients and their lay caregivers.
Instructions to Develop Benefit/Risk Analysis & IFUs for Patients and Laypersons

Benefit/Risk analysis must be given in IFUs in case patients and/or their lay caregivers need to

  • Work on operating, interpreting, and manipulating the device
  • Know about the measures they have to take while using the device e.g. getting to know about the basic warnings, precautions, and contraindications associated with the device’s use
  • Cooperate in preventing, treating, or diagnosing the illness
Instructions Regarding Post-Procedural Care

If considered appropriate, IFU will contain instructions on post-operative or post-procedural care.

Importance of Following Care Regimen

IFU must mention the importance of following care regimen. This care regimen is explained in medical device labeling and motivates the users to follow the instructions.

Operating Instructions

Operating instructions for the medical device must be clear for the patients to follow. While providing information in IFU, the manufacturer should focus on:

  • Providing information such that the user or patient gets a correct insight of operating the device. The manufacturer doesn’t need to provide excessive information regarding the working mechanism of the medical device as this can lead to information overload.
  • Assuming that the user does not know about operating the device at all, therefore he should present it in and understandable manner.
  • Presenting the information in an orderly manner.
  • Stating the purpose and expected outcomes of all the tasks performed by device.
  • Indicating which steps are important to perform and which steps are optional for the user to perform.
  • Reaching most of the population by providing instructions in IFU written at the eighth-grade reading level or below.
  • Clarity of the sentence structure of IFU. It should be understandable to the patient at his first read.

Read about Harmonized standards on IFUs.

IFU Regarding Setup of Medical Device

The setup instructions for medical devices given in IFU must be clear and easy to understand. For a layperson, they can include the following:

  • A complete list of parts of the device
  • A complete list of all tools and materials required for device’s setup
  • Instructions regarding unpacking the medical device
  • Instructions regarding proper disposal of the device’s packing materials
  • Instructions on how to return packaging to the manufacturer for reuse
  • Instructions regarding correct placement of the medical device. These instructions should also indicate whether the device must remain in the same place after its setup or not
  • IFU must instruct any warnings and safety precautions to be considered regarding the setup of the medical device
  • IFU must warn about the outcomes of setting up the device incorrectly
  • These setup instructions must be given in chronological order
  • IFU must indicate any special preparations to be made before primary use of the medical device (e.g., cleaning or disinfecting);
  • The label must have a space to write user-specific instructions
  • The manufacturer can refer the patients in the Medical Device Patient Labeling section of the IFU to consult the relevant person in case of a problem
Checkout Procedure for Safety & Effectiveness

The manufacturer must explain the checkout process clearly for a medical device that requires any type of checkout procedure to determine its safety and effectiveness. This can include:

  • Setup time before each use of the device
  • Process for checking-out in step-by-step fashion
  • Action which the patient should take after finding out that the device is not working properly
  • Instructions on whom to consult upon finding a problem with the device

The manufacturer can also provide a clock or graphic calendar device so that users can determine the correct time of performing checkout on their device.

Clear & Easy-to-Follow Instructions

The manufacturer should include clear and comprehensible instructions in the device’s IFU so that patients can follow them easily. These instructions should include:

  • Any special operations such as hand washing or device warm-up before users use the device
  • Warnings and safety instructions related specifically to the operation of the device. These warnings and safety instructions should be brought into consideration immediately before executing the task;
  • Outcomes of operating device incorrectly;
  • Performing operating steps in logical orders while attaining expected results;
  • A separate space for user-specific instructions, and
  • Consultation from an expert in case of a problem.
Importance of Monitoring Activity of Medical Device

The manufacturer should state examples for the user through which user can ensure whether the device is working correctly or not. He can do so by telling the user to:

  • Check all the connections of leads
  • Check any damage to the wires
  • Check if power connection is established with the device etc.
Instructions for Cleaning the Device

The manufacturer should list down following instructions regarding proper cleaning of the device:

  • Supplies user needs for cleaning
  • Step-by-step procedures user requires to clean the device
  • Frequency of cleaning the device
  • Outcomes of proper cleaning to the user
  • Outcomes of improper cleaning to the user
  • Outcomes of applying improper cleaning solutions and methods
  • Appropriate warning for device cleaning agents used in cleaning the device
  • Appropriate disposal methods of device cleaning agents
Maintenance Instructions

The manufacturer should include the following instructions regarding the device’s maintenance:

  • A clear description regarding maintenance actions the user should take;
  • Outlines for device maintenance if device’s user is a layperson, and
  • For a device that is to be maintained by more than one person (such as by the user and by a biomedical engineer), the manufacturer can divide this in two separate parts. Writing in this way will inform users regarding their scope of responsibilities in cleaning and maintaining the device.

Read about EU MDR Requirements on IFUs.

Instructions Regarding Device’s Storage

The manufacturer should include the following instructions regarding the device’s storage:

  • A clear description on how to prepare storage conditions for proper storage of device
  • Outcomes of storing device improperly
  • Providing information to the user in the case extended storage can affect the device and
  • Including necessary information that addresses extended storage in setup, checkout, operation, and maintenance.
Information Regarding Failure Time

The manufacturer should list the following instructions regarding failure time:

  • Duration till which the device will last
  • Expected results upon failure of the device
  • Letting the user know about the safety of the device and its effects on the patient when the device fails to perform
  • If appropriate, the manufacturer can include this information under the Risks and Benefits section of the label.
Safe Disposal of the Device
  • The manufacturer must provide detailed information regarding the proper and safe disposal of the device.
  • He can also provide information about accessories that come with medical devices. These can include:
    o All appropriate information regarding each accessory for the device that comes with accessories
    o Information about the accessories in a separate accessories section
    o A general warning at the beginning of the medical device print labeling will tell the users about outcomes they can face if they used the accessories other than their recommended use.
Information Regarding Additional Devices

For patients who will receive an additional device after completion of the procedure, the manufacturer will include information about that device in medical device patient labeling. The manufacturer will provide information about

  • Description regarding use of the additional device
  • Symptoms the patient can experience after the treatment
  • Any other information regarding the additional device that can impact the safety and effectiveness of the primary device.
  • How to find a troubleshooting section easily
Additional Information
  • The manufacturer can also include the following additional information:
    o An index
    o Printing date
    o User assistance information

Need FDA Compliant IFUs for your Medical Device?

Alysidia is one of the leading companies in Europe providing electronic solutions to medical device manufacturers all across the Europe and around the globe. If you are a medical device manufacturer who is looking for FDA-compliant electronic IFUs, you can contact us to seek our professional consultancy.

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