Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring: Guidance for Industry and Food and Drug Administration Staff

Description

FDA is issuing this guidance to provide clarification on its enforcement policies and premarket review expectations for certain non-invasive remote monitoring used for patient monitoring at the conclusion of the COVID-19 public health emergency. FDA believes the policy set forth in this guidance may help FDA and other stakeholders transition from COVID-19 operations and processes to normal operations and processes.

Key Topics

Terms and concepts identified from this document

Scope & Applicability

Product Classes

4

Medical Devices

Medical devices intended for human use; Approved or cleared medical devices

Class II

The devices that are the subject of this guidance are Class II non-spinal metallic bone screws and washers

Non-invasive remote monitoring device

Devices measuring physiological parameters to support patient monitoring

Non-Invasive Remote Monitoring Devices

Devices used to acquire patient physiological data without in-clinic visits

Stakeholders

2

Manufacturer

Entity responsible for submitting NDINs

Healthcare providers

HCPs who make evidence-based decisions on medicinal product use.; HCPs to be educated about study participation for their patients.

Regulatory Context

Regulatory Activities

3

Q-Submission Program

mechanism to seek input from the Agency

510(k)

Premarket notification submission type

Premarket Submissions

Submissions containing cybersecurity documentation for FDA review; FDA recommends the requirements and acceptance criteria for each of the above categories be provided in premarket submissions; submissions where documentation for section 524B must be provided

Document Types

2

FDA Fact Sheet: The FDA's Role in Medical Device Cybersecurity - Dispelling Myths and Understanding Facts

Informational document regarding the FDA's role in device cybersecurity.

Labeling

Cybersecurity information should be included in device labeling

Attributes

2

Home setting

Expansion of environment of use from hospital to home

Patient physiological data

Data acquired by non-invasive remote monitoring devices

Technical Details

Clinical Concepts

1

Coronavirus Disease 2019

The COVID-19 pandemic and public health emergency.

Identified Hazards

Hazards

2

Undue risk

Policy applies only when modifications do not create undue risk

Cybersecurity risks

Inclusion of cybersecurity risks as part of informed consent form

Standards & References

External Standards

4

ANSI/UL 2900-2-1

Standard for Software Cybersecurity for Network-Connectable Products

IEC 62304

Standard for software life cycle processes

ANSI/AAMI ES60601-1

General requirements for basic safety and essential performance; Medical electrical equipment - Part 1: General requirements for basic safety and essential performance; Standard where clause 4.2 indicates hazards not specifically addressed should be in risk management.

FDA-recognized consensus standards

Standards used to improve consistency and quality of software development

Related CFR Sections (5)

21CFR807.81§ 807.81 When a premarket notification submission is required.
(a) Except as provided in paragraph (b) of this section, each person who is required to register his establishment pursuant to § 807.20 must submit a premarket notification submission to the Food and Drug Administration at least 90 days before he proposes to begin the introduction or delivery for inRead full regulation →
21CFR870.1130§ 870.1130 Noninvasive blood pressure measurement system.
(a) Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.Read full regulation →
21CFR868.1840§ 868.1840 Diagnostic spirometer.
(a) Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.Read full regulation →
21CFR868.1400§ 868.1400 Carbon dioxide gas analyzer.
(a) Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared Read full regulation →
21CFR10.115§ 10.115 Good guidance practices.
(a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →

Enforcement Impact

Deficiencies cited in Warning Letters referencing the same regulations

Adulterated under section 501(f)(1)(B)

20

Misbranded under section 502(o)

20

Marketing without marketing clearance or approval

5

Failure to adequately establish and maintain procedures for design changes

5

Unapproved Device Violations

4

Failure to establish and maintain procedures for design changes

3

Failure to adequately maintain device history records

2

Failure to adequately validate a process whose results cannot be fully verified

2

Failure to establish and maintain procedures for validating the device design

2

Failure to adequately establish and maintain procedures for receiving, reviewing, and evaluating complaints

2