Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters – Premarket Notification (510(k)) Submissions)-Guidance for Industry and Food and Drug Administration Staff

This guidance document provides recommendations, including bench testing and coating characterizations for 510(k) submissions for peripheral percutaneous transluminal angioplasty (PTA) balloon and specialty catheters. and also provides anatomy-specific testing recommendations and expands on FDA’s current thinking for testing of these devices. FDA is issuing this guidance to clarify FDA’s premarket submission recommendations for PTA catheters and specialty catheters and to promote consistency across submissions.

The class II PTA balloon catheters regulated under 21 CFR 870.1250 and class II specialty catheters regulated under 21 CFR 870.1210 and 21 CFR 870.1250 with product codes listed in the document.

PTA balloon catheters refer to standard peripheral angioplasty ballooncatheters. Specialty catheters can include but are not limited to the following 510(k) devices:infusion catheters, balloon catheters with unique design characteristics (e.g., cutting/scoring),and balloon catheters intended for specific indications (e.g., ISR, post-dilatation of stents).

Medical Device Application Fee Form

Refer below link for the Medical Device Application fee form.

https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/medical-devices/application-information/forms/medical-device-application-fee-form-eng.pdf

Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of Medical Device Regulation (EU) 2017/745)

This best practice guidance document has been developed by members of Team NB who have reviewed the best practice guidance documents submitted by individual Team NB notified body members, with the purpose to develop a unified approach on the expectations of technical documentation submissions from manufacturers.

This technical documentation submission guidance is aligned to the requirements of Medical Devices Regulation [MDR] (EU) 2017/745, described in detail in Annexes II and III of Regulation (EU) 2017/745.

Transition to MDR underway for 63% of outgoing Directives certificates

Team-NB (The European Association Medical Devices – Notified Bodies), surveyed its 33 members to understand the state of the sector and gauge the progress of the transitions to MDR and the In Vitro Diagnostic Regulation (IVDR). One takeaway is that 2022 was the biggest year yet for submissions for certification under MDR. Team-NB called the trend “good news,” while cautioning about getting too encouraged by the evidence of an acceleration in the transition to the new regulations.

Be aware that this positivity needs to be considered, as many applications are for smaller scopes than those on the Directives certificates. We are told that it is mainly because MDR Technical Documentations for all devices are not ready. Moreover, it is to be noticed that the new legislation will require more certificates issued to the MDR Regulation than were issued to the Directives. For example, a certificate will be issued for each class IIb implantable device,” according to a press release from Team-NB.

Principles and Practices for Software Bill of Materials for Medical Device Cybersecurity

This document considers cybersecurity in the context of medical devices that either contain software, including firmware and programmable logic controllers (e.g., pacemakers, infusion pumps) or exist as software only (e.g., Software as a Medical device (SaMD)). The document emphasizes the roles and responsibilities of MDMs and HCPs and provides recommendations on the implementation of an SBOM and increased transparency in the use of software in medical devices, including in vitro diagnostic (IVD) medical devices. While primarily focused on MDMs and HCPs, we believe that other stakeholders, including but not limited to medical device users, regulators, and software component vendors, may also find the concepts discussed in this document useful.

Protection of the cyber healthcare environment is a shared responsibility of HCPs and MDMs. TheSBOM is a common tool to support safety as it can help to mitigate against the potential for patient harm. This document is intended to:

• Provide recommendations for medical device manufacturers in SBOM generation, management, and distribution.
• Provide recommendations to healthcare providers on ingestion and management of an SBOM.
• Demonstrate SBOM use cases for risk management, vulnerability management, and incident response from the perspective of medical device manufacturers and healthcare providers.

Principles and Practices for the Cybersecurity of Legacy Medical Devices

This document is designed to provide concrete recommendations on how to apply the TPLC to legacy devices to aid in the implementation of the framework put forward in the preceding IMDRF N60 guidance. This document is complementary to the IMDRF N60 guidance, and the scope of relevant medical devices (including in vitro diagnostic (IVD) medical devices), as well as the focus on potential for patient harm remain unchanged.

It considers cybersecurity in the context of legacy medical devices that either contain software, including firmware and programmable logic controllers (e.g., pacemakers, infusion pumps) or exist as software only (e.g., Software as a Medical device (SaMD)). It is important to note that due to most regulators’ authority over medical device safety and performance, the scope of this guidance is limited to consideration of the potential for patient harm. For example, threats that could impact performance, negatively affect clinical operations, or result in diagnostic or therapeutic errors are considered in scope of this document. While other types of harm, such as those associated with breaches of data privacy, are important, they are not considered within the scope of this document.

Legacy devices were previously defined in IMDRF N60 guidance as medical devices that cannot be reasonably protected against current cybersecurity threats. This document therefore only addresses legacy devices within the context of cybersecurity, and not all other situations in which a device may be considered “legacy” (e.g., an older model of a medical device).

NEWS: -MedTech Europe welcomes the recent publication of the European Commission’s Q&A on practical aspects of the implementation of Regulation (EU) 2023/607 and calls for continued work to address remaining challenges

After the political approval of both the European Parliament and the Council of the European Union, the European Commission’s proposal for an amendment of the Medical Devices Regulation and IVD Regulation has officially become law on 20 March 2023, with its publication in the Official Journal of the European Union.

Following this major milestone, the European Commission has published a Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices.

Medical Devices: Post Market Surveillance National Competent Authority Report Exchange Criteria and Report Form

This document provides guidance on:

• the criteria to be used for deciding when to exchange information,
• the procedures to follow when exchanging information,
• the forms to use for exchanging information,

Announcements on clinical trials with medical devices and performance studies with vitro diagnostic medical devices

Medical devices, accessories for medical devices, and devices without a medical purpose listed in Annex I of the MedDOare referred to as ‘medical devices’ in this information sheet. This information sheet is valid under the new regulation that came into force on 26 Mai 2021 and it is intended for sponsors of clinical investigations of devices, contract research organisations (CROs), and investigators. It provides guidance on the authorisation process, reporting requirements of sponsors, and the surveillance of clinical investigations by the Swiss Agency for Therapeutic Products, Swissmedic.

In vitro diagnostic medical devices and accessories for such devices are referred to as ‘IVD’ in this information sheet. This information sheet is valid under the new regulation that comes/came into force on 26 Mai 2022 and it is intended for sponsors of performance studies with IVD, contract research organisations (CROs), and investigators. It provides guidance on the authorisation process, reporting requirements of sponsors, and the surveillance by the Swiss Agency for Therapeutic Products, Swissmedic.

MDR/IVDR amendment: Equivalence with EU Regulation on Medical Devices ensured

In the EU, amendments of the EU-MDR 2017/745 regarding transitional periods for certificates, and of the EU-MDR and EU-IVDR 2017/746 regarding the elimination of deadlines for putting devices into service and placing on the market, were published on 20th March 2023. In view of bottlenecks at the notified bodies, these amendments implemented a number of measures in the EU, including extension – under certain circumstances – of the validity of certificates issued under the old legislation until 2027/2028 (depending on classification) and lifting of the deadlines for putting into service and placing on the market (EU-MDR and EU-IVDR).

Until then, as part of its enforcement of therapeutic products legislation, Swissmedic will tolerate the placement of devices on the market in Switzerland which are covered by a valid certificate according to the MDR and IVDR amendments. Anticipating the amendments to the ordinances in enforcement prevents discrepancies in market supply conditions between Switzerland and the EU and ensures legal compliance during the transitional phase. These measures ensure that the devices marketed in the EU continue to be available for Swiss patients.

Medical devices – extended acceptance of CE marked medical devices on the Great Britain market

A statutory instrument has been laid in Parliament, which will enable an extended timeframe for acceptance of CE marked medical devices on the Great Britain market.
Subject to Parliamentary approval this will mean that CE marked medical devices will be accepted on the Great Britain market beyond the current deadline of 30 June 2023.

This will support the ongoing, safe supply of medical devices to Great Britain and is designed to ease the transition to a future strengthened regulatory framework for medical devices.
The government will ensure that there is a proportionate, phased approach to the implementation of the future regulatory framework, which supports system readiness and minimises the risk of supply disruption for UK patients.

Regulating medical devices in the UK

This guidance was updated primarily to reflect an intended extension to acceptance of CE marked medical devices on the Great Britain market beyond 30 June 2023. This guidance has been updated with changes to ‘Summary of key requirements for placing a device on the Great Britain market’, ‘Registrations in Great Britain’, ‘UKCA marking’, ‘CE marking and Notified Bodies’, ‘Labelling requirements’ and ‘Regulation of medical devices in Northern Ireland’ Reference Guides.

Register medical devices to place on the market

How to register your medical devices with the Medicines and Healthcare Products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland.

UPDATE

Added Guidance on registration of medical devices with an expired or expiring CE certificate that is valid under EU Medical Devices Regulations.

Medical devices: guidance for manufacturers on vigilance

Information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA.

Once a medical device has been placed on the UK market, the manufacturer must submit vigilance reports to the MHRA when certain types of incidents that involve their device occur in the UK.
The manufacturer must also take appropriate safety action when required. The manufacturer will need to ensure their device meets appropriate standards of safety and performance for as long as it is in use.

UPDATE

Information and links to the MORE Submissions guidance and MORE production API guidance have been added.

Software and Artificial Intelligence (AI) as a Medical Device

Information for manufacturers, healthcare organisations and professionals, researchers, and patients & public on Software as a Medical Device (SaMD), including Artificial Intelligence as a Medical Device (AIaMD).

Software (including AI) plays an essential part in health and social care. In the UK, many of these products are regulated as medical devices (or as in vitro diagnostic medical devices (IVDs).

This guidance provides access to important Software Group outputs that might be of assistance.

New statutory fees for MHRA services introduced from 1 April 2023

From Saturday 1 April 2023, new fees are being introduced for a range of MHRA services, to ensure the agency covers its costs and achieves financial stability in the years ahead.

The new fees will enable the MHRA to deliver a responsive and efficient regulatory service that protects and improves patient and public health by facilitating access to high-quality, safe, effective and innovative medical products.

MDR/IVDR amendment: Equivalence with EU Regulation on Medical Devices ensured

During the transitional phase, until the Medical Devices Ordinance (MedDO) and the Ordinance on In Vitro Diagnostic Medical Devices (IvDO) are amended, Swissmedic is already going ahead with enforcement according to the EU amendment to avoid jeopardising the supply of medical devices in Switzerland.In the EU, amendments of the EU-MDR 2017/745 regarding transitional periods for certificates, and of the EU-MDR and EU-IVDR 2017/746 regarding the elimination of deadlines for putting devices into service and placing on the market, were published on 20th March 2023.

Swissmedic inspects Class I manufacturers in Switzerland

The new regulation stipulates that devices must be subject to market surveillance (e.g. incidents involving the devices as well as trends that might indicate an increase in the number of complaints or the severity of incidents).

Manufacturers of Class I medical devices (for example surgical shavers, positioning aids, surgical masks or non-sterile wound dressings) have been obliged to ensure that their devices comply with the new regulation. Manufacturers confirm compliance with the new requirements in their declaration of conformity. Swissmedic must be notified of these devices.

Circular for Licensing of Class C & D medical devices

According to the Circular It is pertinent to mention that as per Medical Devices rules (MDR) 2017 manufacturing license of class c and D medical devices the inspection needs to be carried out within 60 days from the date of application by the Medical Device Officers (MDO) of central Licensing Authority (CLA), to ensure the compliance with Fifth schedule of MDR 2017.

In order to have smooth transition from mandatory registration to licensing regime, it is suggestedthat, the manufacturers/importers may apply for grant of manufacturing/import license with all requisite documents and fees as per MDR 2017, through www.cdscomdonline.gov.in portal. Theapplication received will be processed proactively, so that, licensure can be issued within thestipulated time line in order to avoid any disruption of the supply chain of such medical devices andaccess to the patients.

MEDICAL DEVICES NOT REGISTERED ON THE MARKET

In order to ensure the safety and security of medical device users in Malaysia, the Medical Device Authority (MDA) continuously carries out market surveillance. Apart from that, MDA also ensures that medical devices available in the Malaysian market are only registered and from licensed sources.

The use of unregistered medical devices is extremely risky because the safety and performance of the medical device cannot be verified. In relation to that, the public and parties involved are encouraged to check the registration status of a medical device first before purchasing. The check can be made by entering the name, brand, or registration number of the device on the label at the link https://mdar.mda.gov.my.

System for reporting malfunctions during clinical trials of medical devices (machinery, equipment, etc)

Reports of defects and adverse events during clinical trials of medical devices (hereinafter referred to as “clinical trial defect reports”) are subject to Notification No. 0709004 of the Director-General of the Pharmaceutical and Food Safety Bureau, Ministry of Health, Labor and Welfare dated July 9, 2004. 23 “Regarding Clinical Trials of Medical Devices” of the “Enforcement of the Law for Partial Revision of the Blood Collection.

Blood Donation Agency Control Law” (hereinafter referred to as the “enforcement notice”). Notification No. 0330001 of the PFSB dated March 30, 2010, issued by the Director-General of the Pharmaceutical and Food Safety Bureau, Ministry of Health, Labor and Welfare, “Regarding reports of clinical trial defects, etc. related to machinery and equipment to the Pharmaceuticals and Medical Devices Agency,” indicates how to handle this. On February 8, 2013, a ministerial

SaMD Centralized Consultation Desk (Comprehensive Consultation on Medical Device Programs)

In order to promote the early practical application of cutting-edge programmable medical devices (SaMD: Software as a Medical Device), the Ministry of Health, Labor and Welfare and PMDA are conducting SaMD consultations, respectively, as “Medical Device Program Comprehensive Consultation.” We have set up a window to centrally accept.

Applicability of medical device Under the Pharmaceuticals and Medical Devices Act, regulated program medical devices have a purpose as medical devices and may affect the life and health of patients (or users) if they do not function as intended. Programs (software functions) that may cause

Announcement of 112 Annual Medical Device Standards Acceptance List” and “Repealed Previously Accepted Medical Device Standards List

In order to promote the international harmonization of medical device laws and regulations, and assist the industry to follow and refer to them when developing and manufacturing medical devices, the Department continues to promote the approval of medical devices. From 1993 to 110, 11 announcements have been made. Currently A total of 1,081 domestic and foreign medical device standards have been adopted to provide the industry as a reference for R&D and manufacturing of medical devices.

This announcement ” 112 Annual Medical Device Standards Acceptance List” (Appendix 1), a total of 1,156 medical device standards were adopted, including 76 new items, 1 abolished item and 1,079 original approved standards (of which 61 items The standard has been updated).

For the medical device standards adopted in previous announcements, if the original standard version has been abolished, a total of 255 items in the “List of Originally Accepted Medical Device Standards Repealed Over the Years” (Appendix 2) are sorted out. Please adopt the new version or relevant replacement standards as soon as possible.

This case is also published in the announcement area and the special area of medical device regulations of the FDA’s global information website (www.fda.gov.tw).

Announcement of the State Food and Drug Administration on Approving the Registration of 290 Medical Device Products(No. 41 of 2023)

The State Food and Drug Administration approved a total of 290 registered medical device products. Among them, there are 227 domestic Class III medical device products, 33 imported Class III medical device products, 26 imported Class II medical device products, and 4 Hong Kong, Macao and Taiwan medical device products.

Notice of the Center for Device Evaluation of the State Food and Drug Administration on the release of the guidelines for the registration review of six medical device products including drug-coated balloon dilatation catheters (No. 9, 2023)

This guideline is applicable to intravascular recovery devices with classification code 03-13-22 in the “Catalogue for Classification of Medical Devices”. For other intravascular retrieval devices, such as vena cava filter retrieval devices, refer to the applicable sections of this guideline.

The drug-coated balloon dilatation catheter involved in this guideline refers to the drug-coated balloon dilation catheter under the classification code 03-13-06 in the “Medical Device Classification Catalog”, and the management category of this product is Class III. For other products under 03-13-06 that do not fall within the scope of this guideline, or have special designs, or the classification code is not classified under 03-13-06, the registration applicant can refer to the guideline applicable content.

The hernia repair patch involved in this guideline refers to the patch products that are implanted in the body to repair hernia or abdominal wall defect and strengthen the weak abdominal wall. The materials include polypropylene/polyester/polytetrafluoroethylene/polyvinylidene fluoride, etc. Non-absorbable synthetic materials, absorbable synthetic materials such as polylactic acid/polycaprolactone, animal-derived materials, allogeneic materials, composite materials, etc.

This guideline is applicable to care products for soft and/or hard contact lenses that have one or more functions such as cleaning, disinfection, rinsing, soaking, preservation, lubrication, etc. At present, it mainly includes contact lens saline solution, detergent, contact lens chemical disinfection products, multi-functional care solution, contact lens lubricant.

Notice of the Center for Device Evaluation of the State Food and Drug Administration on the release of the guidelines for the registration and review of radio frequency cosmetic devices (No. 8, 2023)

The radio frequency beauty equipment mentioned in this guideline refers to the use of specific frequency radio frequency current (usually above 200kHz) or electric field (usually 13.56 or 40.68MHz) and other electrical energy to act on human tissues to generate thermal effects, so as to achieve skin relaxation, relieve Products that wrinkle the skin, shrink pores, tighten/lift skin tissue, or treat acne, blemishes, or fat reduction (fat softening or breakdown). RF aesthetic devices as covered in this guideline include both stand /table-top (large) devices (typically operating on mains power) and hand-held (small) devices (typically operating on internal power).

For products containing both radio frequency energy and other energy (sound, light, etc.), the radio frequency energy part shall be implemented in accordance with the requirements of this guideline. If RF energy and other energies can be output at the same time, the safety and effectiveness of the product should also be considered in combination with the related effects of other energies, and relevant research should be verified under the state of simultaneous energy output.

The guideline does not apply to high-frequency surgical equipment used in the field of plastic surgery. Although this type of product also uses high-frequency current to act on the human body, what it achieves is the effect of cutting and coagulation, which is different from the mechanism of action of radio frequency beauty equipment mentioned in this guideline.

Notice of the Center for Device Evaluation of the State Food and Drug Administration on the release of the guidelines for the registration and review of quantitative shear wave ultrasonic hepatometers (No. 7, 2023)

This guideline is applicable to quantitative shear wave ultrasonic liver measuring instrument, which belongs to 07 ultrasonic physiological parameter measurement and analysis equipment under 07 medical diagnosis and monitoring equipment classification according to the “Medical Device Classification Catalog”. The code is 07-07-02, and the management category of the product is three categories.

This guideline does not include the content of the ultrasonic image part used to confirm the measurement position, which can be declared with reference to the “Guidelines for Technical Review of Image-based Ultrasound Diagnostic Equipment (Class III)”. The “probe” mentioned below refers to the probe used for hardness measurement. If there are corresponding guiding principles for other functions of the product, they shall also comply with the corresponding guiding principles of the product.

Announcement on the release of the 2023 medical device registration review guidelines compilation plan (No. 6, 2023)

The guiding principles of medical device registration review in the registration application and technical review work, our center has organized the drafting of the compilation plan of the guiding principles of medical device registration review (see the attachment for details), which is now released. It is hoped that relevant manufacturers, industry associations, scientific research institutes and other units in the medical device industry will pay attention to the specific notices or solicitation of opinions on the compilation of various guiding principles of our center, and actively participate in the formulation and revision of the guiding principles for medical device registration review.

Announcement of the Center for Device Evaluation of the State Food and Drug Administration on Issuing the Guidelines for the Registration and Review of Optical Measuring Equipment for Ophthalmology (No. 13,2023)

In order to further standardize the management of ophthalmic optical measuring equipment, the Center for Device Evaluation of the State Food and Drug Administration organized the revision of the “Guiding Principles for the Registration and Review of Ophthalmic Optical Measuring Equipment”.

This guideline applies to diagnostic/ measuring equipment that utilizes optical imaging/measurement principles to obtain ophthalmic biological parameters. The guideline is general requirement for ophthalmic optical measuring equipment. Registration applicants should determine whether the content is applicable based on the specific characteristics of the product.

Notice of the Center for Device Evaluation of the State Food and Drug Administration on the Release of the Guiding Principles for the Registration and Review of Intense Pulsed Light Therapy Devices (2023 Revision) (No. 12, 2023)

In order to further standardize the management of intense pulsed light therapy equipment, the Center for Device Evaluation of the State Food and Drug Administration organized the revision of the “Guidelines for the Registration and Review of Intense Pulse Light Therapy Devices” (2023 revision), which is now released.

This guideline applies to incoherent high-intensity pulsed light devices that use xenon lamps as the light source and whose output wavelength ranges generally from 400 nm to 1200 nm. This type of equipment obtains the required spectral output by coating the light-guiding crystal or inserting a filter. According to the classification rules stipulated in YY 9706.257, the category should be higher than the exemption category. Other broad-spectrum incoherent pulsed light devices with similar light source spectral ranges can also refer to this guideline.

This guiding principle is a guiding document for applicants and technical review personnel. It does not involve administrative matters involved in review and approval, nor is it enforced as regulations. This guiding principle should be used under the premise of complying with relevant regulations. If there are other methods that can meet the regulatory requirements, they can also be used, but detailed research data and verification data should be provided.

Announcement of the Center for Device Evaluation of the State Food and Drug Administration on the release of the guidelines for the registration and review of hemodialysis concentrates (revised in 2023) and other six guidelines for the registration and review of medical device products (No. 15, 2023)

In order to further standardize the management of 6 medical devices including hemodialysis concentrates, the Center for Device Evaluation of the State Food and Drug Administration organized the formulation and revision of 6 registration review guidelines including the “Guidelines for Registration Review of Hemodialysis Concentrates (2023 Revision)”
The hemodialysis concentrate is clinically suitable for patients with acute and chronic renal failure. It is not used for continuous hemodialysis and hemodiafiltration treatment in medical institutions. Continuous renal replacement therapy, etc.This guideline applies to products that comply with the industry standard YY 0598 “Concentrates for Hemodialysis and Related Therapy”. This guiding principle is formulated based on the current regulations and standards system and the current level of understanding. With the continuous improvement of regulations and standards, as well as the continuous development of science and technology.

This guideline applies to the registration of single-use blood separation devices. The single-use blood separation appliance products to which this guideline applies mainly refer to those used in conjunction with active equipment such as blood component separation for the separation of human blood components. The purpose of this guideline is to help and guide the registration applicants to prepare the application materials for the registration of single-use blood separation devices, and also to provide reference for the technical review department.

DRAP issued Consolidated Notification for Regulatory Fees

Drug Regulatory Authority of Pakistan (DRAP) issued a consolidated notification of Regulatory fess for various functions and services. This notification is issued under the section (1) of section 20 of the Drug Regulatory Authority of Pakistan Act, 2012 (XX.I of 2012) read with sub-rule (3) of rule 4 of the Drug Regulatory Authority of Pakistan (Fee and Levy) Rules, 2022, and in supersession of all such previous Notifications. The Drug Regulatory Authority of Pakistan with the approval of the Policy Board has specified these regulatory fees.