Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices and Related Systems Under Section 524B of the FD&C Act-Guidance for Industry and Food and Drug Administration Staff

On December 29, 2022, the Consolidated Appropriations Act, 2023 (“Omnibus”) was signed into law. Section 3305 of the Omnibus — “Ensuring Cybersecurity of Medical Devices” — amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding section 524B, Ensuring Cybersecurity of Devices. The Omnibus states that the amendments to the FD&C Act shall take effect 90 days after the enactment of this Act on March 29, 2023. As provided by the Omnibus, the cybersecurity requirements do not apply to an application or submission submitted to the Food and Drug Administration (FDA) before March 29, 2023

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.

Soft (Hydrophilic) Daily Wear Contact Lenses – Performance Criteria for Safety and Performance Based Pathway

This guidance provides performance criteria for soft (hydrophilic) daily wear contact lenses in support of the Safety and Performance Based Pathway. Under this framework, submitters (you) planning to submit a 510(k) using the Safety and Performance Based Pathway for soft (hydrophilic) contact lenses will have the option to use the performance criteria proposed in this guidance to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device

Intended Use/Indications for Use:

The soft (hydrophilic) daily wear contact lenses that fall within the scope of this guidance are prescription devices intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye for the optical correction of ametropia (myopia or hyperopia with or without astigmatism). The lenses are designed to be frequent replacement or daily disposablelenses.

Soft (hydrophilic) contact lenses with the following indications for use and/or characteristics are outside the scope of this guidance:

• To correct presbyopia
• To enhance or alter the apparent color of the eye
• To act as a bandage or therapeutic lens
• For the management of keratoconusor irregular corneal conditions
• Lenses with special optical performance beyond that of correcting ametropia (e.g., blue light filtering)
• Lenses with special physical performance (e.g., retains moisture, lubricates, reduces deposits)
• Lenses with special health performance characteristics (e.g., relieves dry eye)

SCIENTIFIC COMMITTEE ON HEALTH, ENVIRONMENTAL AND EMERGING RISKS (SCHEER)

Regulation (EU) 2017/745 on medical devices (MDR) establish a legal obligation on the Commission to provide the relevant scientific committee with a mandate to prepare guidelines on the benefit-risk assessment of the presence of phthalates, which belong to either of the groups of substances that are carcinogenic, mutagenic or toxic to reproduction of category 1A or 1B, in accordance with Part 3 of Annex VI to Regulation (EC) No 1272/2008, or that have endocrinedisrupting properties.

The obligation to have the guidance available was set on 26 May 2020 and the document was adopted by SCHEER at plenary meeting on 18 June 2019.
The MDR sets also a legal obligation for the update of the guidance, on the basis of the latest scientific evidence. Such update can be made when appropriate and, at least, every five years.

Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 – Extension of the MDR transitional period and removal of the “sell off” periods

The amendment of the MDR and of the IVDR through Regulation (EU) 2023/607 aims to ensure a high level of public health protection, including patient safety and an avoidance of shortages of medical devices needed for the smooth functioning of healthcare services, without lowering current quality or safety requirements. For that purpose, manufacturers and notified bodies are given sufficiently more time to carry out, in accordance with the MDR, the conformity assessment of devices covered by a certificate or a declaration of conformity issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC. Moreover, the deletion of the ‘sell off’ date in the MDR and the IVDR aims to prevent unnecessary disposal of safe devices.

The answers to the questions set out below have been developed taking into account the objectives pursued by the amendment with a view to making best use of the additional time provided by the extension of the MDR transitional period.

Regulation (EU) 2023/607 of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions

Regulation (EU) 2023/607EN of the European Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices. The Regulation introduces a staggered extension of the transition period provided for in Regulation (EU) 2017/745 on medical devices (MDR), subject to certain conditions. It also deletes in both MDR and IVDR the “sell-off” deadline after which devices placed on the market before or during the transition periods that are still in the supply chain would have had to be withdrawn.

Commission delays notified body reassessments to free up capacity for MDR, IVDR

The European Commission has published delegated regulations to change the frequency that notified bodies are reassessed under the new device and diagnostic regulations.

Under the original Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR), notified bodies designated to certify devices under the rules needed to be reassessed three years after first being notified and every four years thereafter. The need to free up time at existing MDR/IVDR notified bodies and focus authorities’ resources on new assessments led the Commission to rethink the requirements.

The publication of the delegated regulations resets the period between assessments to five years. The new timeline has now taken effect, although some notified bodies may still undergo assessment more frequently than every five years.

Guideline on computerised systems and electronic data in clinical trials

The European Medicines Agency (EMA) has finalized a guideline on computerized systems and electronic data in clinical trials. EMA’s document, which replaces a reflection paper on the same topic, is intended to help stakeholders adapt to increases in the complexity of computerized systems that have happened in recent years.

In setting out the need for guidance, EMA pointed to the rapid changes that have occurred as electronic case report forms, electronic patient reported outcomes, wearable devices and artificial intelligence have become part of the clinical trial landscape. EMA has designed the guidance to help stakeholders use the new technologies while ensuring the quality and reliability of trial data, and the rights, dignity, safety and wellbeing of trial participants.

Expert decision and opinion in the context of the Clinical Evaluation Consultation Procedure (CECP)

In accordance with MDR Annex IX, 5.1.g., the notify body shall provide a full justification where it has not followed the advice of the expert panel in its conformity assessment report.
The notified body is obliged to give due consideration to views expressed in the scientific opinion of the expert panel and in particular in case experts find the level of clinical evidence not sufficient or have serious concerns about the benefit-risk determination, the consistency of the clinical evidence with the intended purpose including the medical indications or with the post-market clinical follow-up (PMCF) plan.

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.

The amending decree extending the transition periods of the medical device regulations entered into force

The amending regulation approved by the EU Council on March 7, 2023, which conditionally extends the validity periods of certificates in accordance with medical device directives, has been published in the EU’s official journal and entered into force on March 20, 2023.The decree also removes the restrictions on the last date for the sale of medical devices and in vitro diagnostic devices in accordance with the directives. These measures will reduce the possible risk of a shortage of medical equipment.

In order to take advantage of the new transition periods, devices and manufacturers must meet certain conditions. These conditions aim to ensure that the additional time is only applied to devices that are safe and for which the manufacturers have already started the certification process.

Decree extending the validity of medical device certificates approved

On March 7, 2023, the EU Council approved a regulation extending the validity periods of certificates in accordance with the medical device directives. The decree also removes the restrictions on the last date for the sale of medical devices and in vitro diagnostic devices in accordance with the directives. These measures will reduce the possible risk of a shortage of medical equipment. The regulation will enter into force immediately after it has been published in the official journal within the next few weeks.

The expiry date of the certificates according to the directives defined in the MD regulation for medical devices is 26 May 2024. With the now approved regulation, the validity dates of the certificates are extended to the end of 2027 and 2028, depending on the risk categories of the devices.

EMA launches pilot of medical device clinical trial advice

The European Medicines Agency (EMA), which has been coordinating the work of expert panels for medical devices since March 2022, will start piloting the scientific advice for clinical research mentioned in the MD regulation. The pilot lasts about a year. The goal of the service is stronger support for innovations in the EU area and faster access to the market for safe and efficient devices.

The pilot is looking for devices on the widest possible scale from different fields of medicine. EMA prioritizes devices that: -benefit a relatively small group of patients, e.g. devices aimed at pediatric use is aimed at life-threatening situations or otherwise serious situations for which there is currently no adequate treatment or the current treatments are particularly risky are new devices that achieve a significant clinical or health benefit.

Extension of CE certificates

The EU has taken steps to give manufacturers more time to get certain medical devices certified under the EU Medical Devices Regulation (EU MDR). The new arrangements recognise the challenges in capacity across notified bodies.

Key changes include:

Extension of the transitional period for higher-risk devices (class III and certain class IIbimplantables), such as pacemakers, to comply with EU MDR requirements until 31 December 2027, subject to certain conditions (including requirements for post-market surveillance, quality management systems, and engagement with notified bodies).

Extension of the transitional period for medium and lower-risk devices (other class IIb devices, class IIa, class Im, Is and Ir devices), such as syringes, to comply with EU MDR requirements until 31 December 2028, subject to certain conditions (including requirements for post-market surveillance, quality management systems, and engagement with notified bodies).

Register medical devices to place on the market

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

Updates to the Review Registration, Making Changes to your registration and Public Register of Manufacturers sections.Updated Account Management and Device Registration Reference Guides.

Export medical devices

It explains about the Order a certificate of free sale to export medical devices outside the UK.

A CFS should not be taken as a Government endorsement of any product that is referred to on the certificate. In issuing a CFS, the MHRA does not assess or verify that the product complies with relevant export requirements and restrictions. It is the applicant’s responsibility to ensure compliance with these requirements and restrictions.

Crafting an intended purpose in the context of Software as a Medical Device (SaMD)

Guidance on defining intended purpose for Software as a Medical Device (SaMD), to help SaMD manufacturers in meeting their statutory obligations. MHRA consider an inadequately defined intended purpose as a potential serious failure to meet key medical device requirements. For instance, where this amounts to a failure to provide adequate information needed to use the SaMD safely and properly.

This document is aimed at manufacturers of SaMD, including standalone software and apps. The purpose of the document is to explain the benefits of having a clear and accurate intended purpose. It has not been specifically drafted for products with hardware components with a medical purpose but also contain software e.g., Software in a Medical Device (SiMD). Nevertheless, the core principles of this document may be of assistance to all medical device manufacturers.

Extending and expanding the intended purpose and alterations in relation to change management activities are outside the scope of this guidance document.

Extension to MDR transitional provisions

This extension gives more time to notified bodies and manufacturers to certify devices under the MDR. It aims to avoid disruption to the supply and availability of devices and health care in the EU.

Industry stakeholders should read and review the Regulation to understand how the extension may impact their organisation.

The extension will apply to a medical device if:

1. It meets the specific criteria outlined in Regulation (EU) 2023/607.
2. Its certificate expires after 20 March 2023.

Where a device meets the specific criteria but its certificate expired before 20 March 2023, Irish-based manufacturers should email us at [email protected].

Application for a Clinical Investigation of Non-CE Marked Medical Devices (Article 62 MDR)

Sponsors who wish to submit an application to the HPRA for a clinical investigation falling under Article 62 of EU Regulation 2017/745 (MDR) are required to complete this application form and submit it with the relevant supporting documentation as described below.
Validation of this application will be completed and review will commence only once all relevant application documentation is submitted. If completed documentation is not received within the timeframe specified in a notification of an incomplete application from the HPRA, the application will be deemed lapsed.

Medical safety measures related to pharmaceuticals and medical devices

The Ministry of Health, Labor and Welfare is promoting various efforts to prevent medical accidents, but it is also possible to change the names, containers, and specifications of pharmaceuticals, medical devices, and other products used in medical settings to those that are less likely to cause medical accidents. The MOHLW believe that it will be one of the preventive measures, and we are proceeding with the construction of a system that will materialize.

Based on the discussions at this committee, MOHLW have decided to implement the following measures as measures to prevent medical accidents related to drugs and medical devices.

“Regarding the revision of the medical device defect glossary based on the IMDRF defect glossary”

Reporting of malfunctions, etc. of medical devices (hereinafter referred to as “defect “Reports of Malfunctions, etc. of Medical Devices” (Notification No. 0131 of the Safety of PSEHB dated January31, 2020 by the Director of the Pharmaceutical Safety Division, Pharmaceutical Safety and Environmental Health Bureau, Ministry of Health, Labor and Welfare).

Regarding the glossary of medical device malfunctions, please refer to “Publication of Medical Device Malfunction Glossary based on IMDRF Malfunction Glossary” (Pharmaceuticals and Medical Devices Agency Medical Device Quality Administration and Safety Department Office Communication), a translated version of “IMDRF terminologies for categorized Adverse Event Reporting (AER): terms, terminology structure and codes” compiled by the International Medical Device Regulators Forum (IMDRF) (hereinafter referred to as “IMDRF We are pleased to inform you that a glossary of medical device malfunction terms has been compiled based on the “Glossary of Malfunction Terms”. Recently, “Revision of the translation version of the IMDRF glossary of medical devices” (Administrative Notice of the Pharmaceutical Safety Division

Regarding the revision of the medical device defect glossary based on the IMDRF defect glossary (Incorporated Administrative Agency Pharmaceuticals and Medical Devices Agency Medical Device Quality Control and Safety Department Office Communication dated March 17, 2023)

Announcement is established for the benefit of medical device manufacturers and research institutions, in the process of R&D, marketing and management of medical device products, it is appropriate to include gender differences in the recruitment of subjects, research design, statistical analysis, data interpretation and disclosure of research results in clinical trials. The content, etc. shall be considered, and supplemented as the basis or supporting information for the efficacy or safety of medical devices, and the announcement shall formulate the guidelines.
This case is also published in the announcement area and the medical device clinical trial area of the FDA’s global information.

List of Notified Bodies registered with CDSCO under MDR, 2017

The notified bodies registered with CDSCO under provisions Medical device rules 2017 carry out audit of manufacturing site under the provisions of said rules. In this connection,following Notified bodies have been registered with CDSCO.

List of medical devices testing laboratory (MDTL) for carry out test or evaluation of medical device on behalf of manufacturer registered with CDSCO under MDR 2017

The updated list of medical devices testing laboratory (MDTL) for carry out test or evaluation of medical device on behalf of manufacturer registered with CDSCO under MDR 2017 (Form MD -40).

MFDS supports export of medical devices beyond regulatory barriers with global leadership

The Ministry of Food and Drug Safety (MFDS) of the Republic of Korea (Minister Oh Yu-Kyoung) attended the annual meeting of the Global Harmonization Working Party (GHWP*, Riyadh, Saudi Arabia) from February 13 to 16, where it strengthened global network for cooperation in the field of medical devices to take a main role for digital health and sought ways to support the export of domestic products.

In addition, with the experience and expertise of having the MFDS’ AI medical device guidelines adopted as international common guidelines during its chairmanship of IMDRF*, the MFDS began discussions at the GHWP on adoption of its ‘Guidelines on review and approval of AI-based histopathologic in-vitro diagnostic medical devices (software)’ as international common guidelines.

CLASSIFICATION OF REHABILITATION, PHYSIOTHERAPY AND SPEECH THERAPY DEVICE

This guidance document provides the classification of a list of products used for rehabilitation, physiotherapy and speech therapy by determining whether they are medical devices or non-medical devices based on their intended purpose as claimed by the manufacturer.

The definition of medical device is legally binding in the Medical Device Act 2012 (Act 737) and it determines the scope of regulatory control of the product. This definition differentiates medical devices and not medical device based on clear indication on mode of action for the product been used for rehabilitation, physiotherapy and speech therapy.

MEDICAL DEVICES NOT REGISTERED ON THE MARKET

In order to ensure the safety and security of medical device users in Malaysia, the MedicalDeviceAuthority (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.

All companies including retailers are also reminded not to sell unregistered medical devices to avoid any enforcement action being imposed. The sale or distribution of unregistered medical devices is an offense under Section 5, Medical Devices Act 2012 (Act 737) which may result upon conviction, in a fine not exceeding RM200,000.00 or imprisonment for a period not exceeding three years or both.

WITHDRAWAL OF MEDICAL DEVICE REGISTRATION (NEW AND RE-REGISTER) AND CHANGE OF NOTIFICATION APPLICATION

MDA will withdraw the medical device registration (new and re-register) application and change notification application that has not been completed within 30 working days. However, a transitional period is given to applicant until 1st May 2023 for the full implementation on withdrawal of the medical device registration (new and re-register) application and change notification application.

Submission of medical device registration (new and re-register) and change notification application shall be provided with the information, particulars or document as stated in the Medical Device Act 2012 [Act 737], Medical Device Regulations 2012, guidance documents and guidelines which has been provided on the MDA website (portal.mda.gov.my).

ABORTION OF REGISTRATION APPLICATIONS (NEW AND RENEWAL) AND MEDICAL DEVICE AMENDMENTS

MDA will drop medical device registration applications (new and renewed) and incomplete medical device amendment applications within 30 working days. However, a transition period is given to applicants until May 1, 2023 before the abort process for medical device registration applications (new and re-) and incomplete medical device amendment applications is fully implemented.

The submission of medical device registration applications (new and renewed) and medical device amendment applications must be accompanied by information, details or documents as stipulated in the Medical Devices Act 2012 [Act 737], Medical Devices Regulations 2012, circulars MDA, related guidance documents and guidelines that have been placed on the MDA website (portal.mda.gov.my).

Incomplete applications will be returned to the establishment to be completed. The applicant must provide the required information or documents within 30 working days. The application will be dropped if:

1. 1. The establishment does not provide feedback as required within 30 working days; or
   2. Applications are returned by establishments without complete documents or information. Accordingly, the establishment needs to check that the information or documents provided are correct and complete before returning them to the MDA.

However, dropping this application does not affect the establishment’s right to make a new application. Application fees for dropped applications will not be refunded.

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 two medical device products including dental adhesive products

This guideline applies to dental adhesive products for dental filling restoration and prosthetic restoration bonding. This guideline does not apply to products of special design and innovative design.

This guideline applies to artificial shoulder prostheses, which typically include humeral components (e.g., humeral head, humeral stem, humeral liner, humeral socket), glenoidcomponents (e.g., glenoid liner, glenoid socket, glenoid head, fixation Screws), usually made of cobalt chromium molybdenum alloy, titanium alloy, ultra-high molecular weight polyethylene, ceramic materials.

This guideline does not include the requirements for specially designed products such as patient-matched personalized artificial shoulder prosthesis, but the applicable parts can refer to the corresponding technical content in this guideline.

Notice on Soliciting Proposals for Pre-approval of Standards of National Medical Device Clinical Evaluation Standardization Technology Units in 2024

In accordance with relevant regulations such as the “National Standard Management Measures”, “Medical Device Standard Management Measures” and “Medical Device Standard Development and Revision Work Management Regulations”, in order to do a good job in the standard formulation work in 2024, we are now openly soliciting the 2024 medical device clinical evaluation field standard forecast Project proposal.

Clinical evaluation of medical devices (including clinical trials) and clinical trial quality management and general requirements for in vitro diagnostic reagents, excluding clinical evaluation requirements for specific products.

HSA Updates on Recent US FDA Announcements about Certain COVID-19 Antigen Rapid Self-Test Kits

The Health Sciences Authority (HSA) has received several enquiries on the recent antigen rapid self-test kit announcements by the United States Food and Drug Administration (US FDA).

In Singapore, only COVID-19 antigen rapid self-test kits that have been authorised by HSA under the Pandemic Special Access Route (PSAR) or full registration can be supplied. HSA has evaluated these test kits to meet the required safety, quality and efficacy standards before granting PSAR authorisation or full registration.

GL-08: Regulatory Guidelines for Laboratory Developed Tests (LDTs)

This document provides guidance and clarity in assisting clinical laboratories on understanding the regulatory requirements applicable to Laboratory Developed Tests (LDTs) under the Health Products Act 2007 (HPA) and Health Products (Medical Devices) Regulations 2010 (HP (MD) Regulations).

LDTs are in vitro diagnostics (IVD) that fall within the scope of the definition of medical devices stipulated under the first schedule of the HPA. This guideline is applicable to all LDTs (i.e. products including test reagents, and kits) developed within a licensed clinical laboratory solely for use within the same laboratory. This does not include test reagents and kits developed within a licensed clinical laboratory and distributed outside of the laboratory where it was developed as these will be regulated as commercial IVD products by HSA.

FDA Circular No.2021-002-C || Guidelines on the Regulatory Flexibility for Class B, C and D Medical Devices that are Not Included in the List of Registrable Medical Devices Based on FDA Circular No. 2020-001-A entitled “Amendment to Annex A of FDA Circular No. 2020-001 re: Initial Implementation of Administrative Order NO. 2018-0002 “Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAN Harmonized Technical Requirements””

This issuance shall apply to Class B, C and D medical devices that are not included in the list of registrable medical devices based on FC No. 2020-001 – A shall be accepted until 31 March 2023; receiving of application for CMDN for these medical devices shall cease starting 1 April 2023; and all manufacturers, traders, exporters, importers, and distributors of the said medical devices shall secure a Certificate of Medical Device Registration (CMDR) starting 1 April 2023.
On 21 April 2022, FC No. 2021-002-B was issued to extend the date wherein all Class B, C and D medical devices that are not included in the list of registrable medical devices based on FC No. 2020-001-A.

In consideration of the challenges brought about by the full implementation of Administrative Order No. 2018-0002, the FDA recognizes that there is a need to provide medical device companies more time to prepare the technical documentary requirements based on the ASEAN common submission dossier template (CSDT) in applying for CMDR.