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USA/Europe Med Device Regulatory 2023 News/Updates recap

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BELGIUM


CANADA


CZECH REPUBLIC


EUROPE

Summary IVDR codes coverage:


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USA

The purpose of this guidance is to provide further clarification and updated information on the use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” to support applications to FDA. This guidance document also incorporates several considerations, including the use of risk-based approaches to determine if biocompatibility testing is needed, chemical assessment recommendations, and recommendations

The scope of this document and accompanying attachments is limited to the biological evaluation of sterile and non-sterile medical devices that come into direct or indirect contact with the human body. This document specifically covers the use of ISO 10993-1 but also is relevant to other biocompatibility standards (e.g., other parts of the ISO 10993 series of standards, ASTM, ICH, OECD, USP).

Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors

The guidance is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors in complying with FDA’s informed consent regulations for clinical investigations. This document is structured to first present general guidance on FDA’s regulatory requirements for informed consent and a discussion of the roles of IRBs, clinical investigators, sponsors, and FDA related to informed consent, followed by a series of frequently asked questions.

The term informed consent is mistakenly viewed as synonymous with obtaining a subject’s signature on the consent form; however, obtaining documentation of a subject’s informed consent is only part of the consent process. Informed consent involves providing a prospective subject, or their legally authorized representative (LAR), with adequate information to allow for an informed decision about participation in the clinical investigation prior to enrollment. Informed consent also involves facilitating the prospective subject’s understanding of the information, providing adequate opportunity for the prospective subject to ask questions and to consider whether to participate, obtaining the prospective subject’s voluntary agreement to participate prior to enrollment, and continuing to provide information as the clinical investigation progresses or as the enrolled subject or situation requires

Off-The-Shelf Software Use in Medical Devices

The guidance document is intended to provide information regarding the recommended documentation sponsors should include in a premarket submission for FDA’s evaluation of off the-shelf (OTS) software used in a medical device. The recommendations in this guidance are also intended to facilitate FDA’s premarket review. This guidance describes information that would be typically generated and documented during software development, verification, and validation. The least burdensome approach was applied to identify the minimum amount of information that, based on our experience, would generally be needed to support a premarket submission for a device that uses OTS software.

For the purposes of this guidance, unless otherwise stated, the term premarket submission includes, but is not limited to, premarket notification (510(k)) submission, De Novo classification request, Premarket Approval (PMA) application, Investigational Device Exemption (IDE), or Humanitarian Device Exemption (HDE).

Medical Device User Fee Rates for Fiscal Year 2024

The FD&C Act, as amended by MDUFA V, authorizes FDA to collect user fees for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration.

The US FDA has released its fee schedule for fiscal 2024. Standard PMAs will cost $483,560 next year, while 510(k) fees are set at $21,760.

Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations – Premarket Notification (510(k)) Submissions

This guidance to provide labeling recommendations for hydrogen peroxide-based contact lens care products (HPCPs) submitted in premarket notification (510(k)) submissions. This guidance document applies to all HPCPs. These devices are classified under 21 CFR 886.5918 and 21 CFR 886.5928 with the product codes listed in the document.

These labeling recommendations are important because misuse associated with these devices has resulted in serious eye injuries. FDA believes that the labeling recommendations in this guidance may help manufacturers develop labeling with information about specific risks and directions for use of the HPCPs in conjunction with a user’s prescribed contact lenses. These labeling recommendations are intended to promote the safe and effective use of HPCPs and ensure that consumers receive and understand information regarding the benefits and risks associated with the use of the device.

Qualification of Medical Device Development Tools

The purpose of this guidance is to describe the framework for voluntary proposal and qualification of an MDDT, including definitions of applicable terms, criteria for evaluating an MDDT for a specific context of use, considerations for qualification, and the contents of a qualification package. For purposes of this guidance, a submitter is a person, group, consortium, or organization (including the federal government) that takes responsibility for and initiates the MDDT qualification process using the procedures described in this guidance.

This guidance does not discuss the review of MDDTs (also referred to as “tools” in this guidance) that are submitted in individual premarket regulatory submissions for use with a particular medical device, nor does it address the specific evidentiary or performance expectations for the qualification of an individual MDDT submission.

Content of Premarket Submissions for Device Software Functions

The purposes of this document, FDA refers to a software function that meets the definition of a device as a device software function.

This guidance recommends the information to provide in a premarket submission that includes a device software function(s). For the purposes of this guidance, the term premarket submission includes, but is not limited to, premarket notification (510(k)) submission, De Novo classification request, Premarket Approval (PMA) application, Investigational Device Exemption (IDE), Humanitarian Device Exemption (HDE), or Biologics License Application (BLA). Certain devices are subject to premarket review through a BLA under section 351 of the Public Health Service Act.

This guidance does not apply to automated manufacturing and Quality System software or software that is not a device. For further information or to clarify the documentation expectations, please contact the responsible FDA review division.

Generally, the recommendations in this guidance apply to the device constituent part of a combination product18 (such as drug-device and biologic-device combination products) when the device constituent part19 includes a device software function, including combination products assigned to CDER and CBER regulated under drug or biological product market submission types. For more information, contact the FDA review Division that will have the lead review for the combination product.

General Considerations for Animal Studies Intended to Evaluate Medical Devices

This guidance is applicable to animal studies intended to provide evidence of device safety, which may include performance and handling, in premarket submissions to FDA. These types of submissions include investigational device exemption (IDE) applications, premarket approval applications (PMA), premarket notification (510(k)), humanitarian device exemption (HDE) applications, or De Novo classification requests. This guidance is not intended to alter or supersede any device specific final guidance but is intended to augment the recommendations in device-specific guidance.

This guidance also does not apply to basic exploratory studies conducted to determine whether a device has any potential utility or preliminary assessments of physical or chemical characteristics of a device. In addition, this guidance does not apply to, nor changes any regulatory requirements relevant to, animal studies conducted under the Animal Rule.21 Finally, this guidance is not intended to address the regulations and policies of other agencies.

Laser Products – Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56)-Guidance for Industry and Food and Drug Administration Staff

The guidance describes the Food and Drug Administration’s (FDA) approach regarding manufacturers’ compliance with FDA’s performance standards for laser products. FDA regulates radiation-emitting electronic products, including all types of lasers products. Laser product means any manufactured product or assemblage of components which constitutes, incorporates, or is intended to incorporate a laser or laser system. A laser or laser system that is intended for use as a component of an electronic product shall itself be considered a laser product (see 21 CFR 1040.10(b) (21)).

The Agency sets radiation safety product performance standards that must be met by manufacturers in order for laser products to be legally sold in the U.S. market. Laser products may fall under both the definition of a medical device and that of an electronic product, under sections 201(h) and 531(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), respectively. Such products are subject to the provisions of the FD&C Act and its implementing regulations that apply to medical devices1 and electronic products.

Medical X-Ray Imaging Devices Conformance with IEC Standards-Guidance for Industry and Food and Drug Administration Staff

This guidance addresses diagnostic x-ray imaging systems and their major components (see 21 CFR 1002.1 and 21 CFR 1020.30(a)(1)). Most diagnostic x-ray imaging systems and their major components are classified as Class I or II devices. And also includes the regulations and product codes for these devices. The guidance does not address radiation therapy products because there are no EPRC performance standards promulgated for these products. These devices are cleared for market through the 510(k) process.

Marketing Clearance of Diagnostic Ultrasound Systems and Transducers- Guidance for Industry and Food and Drug Administration Staff

This guidance document provides detailed recommendations for 510(k) submissions for diagnostic ultrasound systems and transducers. In addition to outlining regulatory approaches for certain diagnostic ultrasound devices, this guidance document describes the types of modifications to a diagnostic ultrasound device for which FDA does not intend to enforce the requirement for a new premarket notification (510(k)).

Safety of diagnostic ultrasound technology

Exposure of tissues to intense levels of ultrasound that are well above the levels found in typical diagnostic ultrasound devices can have significant biological effects. Therefore, determinations of substantial equivalence have been made in part by comparing the appropriate acoustic output levels of new devices to those of predicate devices of this type that were on the market prior to May 28, 1976, the date of the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act), which are known as “preamendments devices.

Marketing Clearance of Diagnostic Ultrasound Systems and Transducers- Guidance for Industry and Food and Drug Administration Staff

This guidance document provides detailed recommendations for 510(k) submissions for diagnostic ultrasound systems and transducers. In addition to outlining regulatory approaches for certain diagnostic ultrasound devices, this guidance document describes the types of modifications to a diagnostic ultrasound device for which FDA does not intend to enforce the requirement for a new premarket notification (510(k)).

Safety of diagnostic ultrasound technology

Exposure of tissues to intense levels of ultrasound that are well above the levels found in typical diagnostic ultrasound devices can have significant biological effects. Therefore, determinations of substantial equivalence have been made in part by comparing the appropriate acoustic output levels of new devices to those of predicate devices of this type that were on the market prior to May 28, 1976, the date of the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act), which are known as “preamendments devices.

Medical Devices; Neurological Devices; Classification of the Digital Therapy Device to Reduce Sleep Disturbance for Psychiatric Conditions

The Food and Drug Administration (FDA) is classifying the digital therapy device to reduce sleep disturbance for psychiatric conditions into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the digital therapy device to reduce sleep disturbance for psychiatric conditions’ classification.

US FDA is taking this action because they have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device and believe this action will also enhance patients’ access to beneficial innovative devices.

Medical Devices; Cardiovascular Devices; Classification of the Hardware and Software for Optical Camera-Based Measurement of Pulse Rate, Heart Rate, Breathing Rate, and/or Respiratory Rate

The Food and Drug Administration (FDA) is classifying the hardware and software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the hardware and software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate’s classification.

US FDA is taking this action because they have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device and believe this action will also enhance patients’ access to beneficial innovative devices.

Medical Devices; Orthopedic Devices; Classification of the Resorbable Shoulder Spacer

The Food and Drug Administration (FDA) is classifying the resorbable shoulder spacer into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the resorbable shoulder spacer’s classification.

Medical Devices; Physical Medicine Devices; Classification of the Electroencephalography-Driven Upper Extremity Powered Exerciser

The Food and Drug Administration (FDA) is classifying the electroencephalography (EEG)-driven upper extremity powered exerciser into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the electroencephalography (EEG)-driven upper extremity powered exerciser’s classification.

Medical Devices; Physical Medicine Devices; Classification of the Virtual Reality Behavioral Therapy Device for Pain Relief

The Food and Drug Administration (FDA) is classifying the virtual reality behavioral therapy device for pain relief into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the virtual reality behavioral therapy device for pain relief’s classification.

Medical Devices; Neurological Devices; Classification of the Brain Stimulation Programming Planning Software

The Food and Drug Administration (FDA) is classifying brain stimulation programming planning software into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the brain stimulation programming planning software’s classification.