The Food and Drug Administration (FDA) has issued draft guidance entitled Technical Performance Assessment of Quantitative Imaging in Device Premarket Submissions for public comment1,2. Quantitative imaging (i.e. the extraction of information from medical images in the form of numerical values)…
A period of public consultation has been held on a draft guidance document that sets out general recommendations for Q-Submissions and Investigational Device Exemptions (IDEs) for implanted Brain-Computer Interface (BCI) devices for patients with paralysis or amputation1,2. Implanted BCI devices…
New guidance entitled Medical Devices Containing Materials Derived From Animal Sources (Except for In Vitro Diagnostic Devices) has updated a guidance of the same name from November 1998 on the use of animal-derived material in medical device manufacturing1,2. The guidance…
The Food and Drug Administration’s (FDA’s) current thinking on using performance criteria to demonstrate substantial equivalence for pre-market notification (510(k)) submissions has been published as a final guidance document1,2. The final guidance, which is entitled Safety and Performance Based Pathway,…
In February 2019, Health Canada revised its list of recognised standards for medical devices1. The latest version (25 February 2019) includes the addition of 14 new standards, updates to 13 standards and the removal of eight standards. Reference https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/standards/list-recognized-standards-medical-devices-guidance.html
Introduction A new regulatory system for medical devices is being implemented in the European Union. The old Directives on medical devices are being replaced by a single Regulation on medical devices. Directives 93/42/EEC on medical devices (MDD)1 and 90/385/EEC on…
Introduction The Breakthrough Devices Program (BDP) and the Safer Technologies Program (STeP) are Food and Drug Administration (FDA) programmes intended to incentivise and speed the development of innovative medical devices that meet certain criteria.The BDPincentivises development of medical devices that…
ISO/DIS 14155, Clinical investigation of medical devices for human subjects -- Good clinical practice has been circulated for technical comment (ballot)1. This draft third edition of the standard has been prepared by Technical Committee ISO/TC 194, Biological and clinical evaluation…
Three new technical documents have been finalised by the International Medical Device Regulators Forum (IMDRF) and posted on their website: IMDRF/Standards WG/N51 FINAL:2018, Optimizing Standards for Regulatory Use This guidance offers clear recommendations to regulatory authorities, standards development organisations…
Mandatory Israeli Standard SI 798 Part 1, dealing with spectacle lenses for ophthalmic optics, is to be replaced by: SI 798 Part 1, Ophthalmic optics – Uncut finished spectacle lenses: Specifications for single-vision and multifocal lenses1, which adopts ISO 8980-1:…
Normative Instruction (IN) 291, dated 27 November 2018, updates Annex I to IN 4/2015 containing the list of technical standards that have been adopted for use in conformity assessment. It also updates Annex II to IN 4/2015 regarding the list of…
The Food and Drug Administration has announced1 the withdrawal of two previously proposed rules because these proposed rules are not currently considered viable candidates for final action: Laser Products; Proposed Amendment to Performance Standard (FDA-2011-N-0070); Electronic Submission of Labeling…
Minor changes have been made to the recommendations on leadless cardiac pacemaker therapy published by the Medicines and Healthcare products Regulatory Agency’s Expert Advisory Group1. The changes reflect the clinical experience gained over the last year, including operator experience and…
Interested parties had until 19 October 2018 to comment on the first edition of draft Uganda standard DUS 2011:2018, Sterile surgical blades – Specification1. This draft standard specifies the requirements, methods of testing and sampling methods for sterile surgical blades.…
On 18 September 2018, the Saudi Food and Drug Authority (SFDA) issued MDS-G29, Guidance for the Medical Devices Samples for Laboratory Testing, version 1.01. The purpose of this guidance is to clarify the procedure for laboratory testing of medical device…
An amendment has been proposed to the Standards of Medical Device Good Manufacturing Practices (GMP) in the Republic of Korea1. If finalised, the amendment would harmonise Korea’s requirements with international practices by adopting ISO 13485: 2016. It would improve the…
Public consultation has been held on a proposed revision1 to the mandatory Israeli Standard SI 1268 Part 3, Syringes and needles: Sterile hypodermic syringes for single use – Syringes for manual use. This draft revision adopts ISO 7886-1:2017, Sterile hypodermic…
The use of Egyptian Standard ES 1595-1, Rubber gloves for medical use – Part 1: Single-use sterile rubber surgical gloves – Specification, has become mandatory following the publication of Ministerial Decree No 477/20181. Producers and importers have been provided with…
On 22 October 2018, the US Food and Drug Administration (FDA) published another significant update to its list of recognised consensus standards entitled Modifications to the List of Recognized Standards, Recognition List Number: 0501. These standards are intended to help…
Guidance has been developed to explain the procedures that the Center for Devices and Radiological Health (CDRH) follows, and the actions it may take, when it receives a request for recognition of a voluntary consensus standard1,2. The draft guidance clarifies…
A final guidance document has been published to assist industry and Food and Drug Administration (FDA) staff in the appropriate use of national and international voluntary consensus standards during the preparation and evaluation of pre-market submissions for medical devices1,2. According…
Interested parties have until 9 November 2018 to submit comments on Health Canada’s proposed changes to the Therapeutic Products Directorate’s (TPD’s) List of Recognised Standards for medical devices1. The proposed changes include removing eight standards, adding 15 new standards, and…
Interested parties have until 15 December 2018 to comment1 on a Draft Commission Implementing Decision amending Decision 2002/364/EC as regards requirements for hepatitis C virus (HCV) antigen/antibody combined tests and nucleic acid amplification techniques (NAT) in qualitative human immunodeficiency virus…
Voting by the national standards’ organisations on ISO/DIS 14155:2018(E), Clinical investigation of medical devices for human subjects – Good clinical practice, began on 19 June 2018. The closing date for comments is set as 11 September 20181. The Technical Committee…
The Draft International Standard (DIS) of the newly-revised ISO 14971, Medical devices – Application of risk management to medical devices, was circulated to the national standards’ organisations in July 2018 for comment1,2. At the same time, the latest Working Draft…
Five medical device-related Kenyan Standards (KSs) have been circulated for comment and are scheduled for adoption on 1 September 2018: KS 2551:2018, Sphygmomanometers, mercurial – Specification1; KS 2552:2018, Mouth props and airways (London Hospital Pattern) – Specification2; KS 2553:2018, Anaesthetic…
At its 79th meeting on 16 May 2018, the Drugs Technical Advisory Board (DTAB) considered a number of proposed amendments1 to the Medical Devices Rules, 2017, including an expansion of the list of notified medical devices. Details of the Board’s…
The effective date for the implementation of IS/ISO 15197: 2013 has been confirmed as 18 October 20191. The Indian Standard (IS) adopting ISO 15197:2013, In vitro diagnostic test systems – Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus, was…
Manufacturers of self-test instruments for glucose monitoring and any associated consumables must adhere1 to the requirements of ISO 15197: 2013, In vitro diagnostic test systems – Requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus2, when registering,…
On 7 June 2018, the US Food and Drug Administration (FDA) published a significant update to its list of recognised consensus standards entitled Modifications to the List of Recognized Standards, Recognition List Number: 0491. These standards are intended to help…
On 9 May 2018, the US federal government published its spring 2018 Unified Agenda of Federal Regulatory and Deregulatory Actions1, which provides federal agencies with the opportunity to update the public on the government’s regulatory priorities. One of the identified…
Interested parties have until 14 August 2018 to submit feedback on two draft guidance documents that provide industry and Agency staff with recommendations on the least burdensome means of assessing the performance of catheters, guidewires and delivery systems submitted in…
Introduction The Food and Drug Administration (FDA) Commissioner, Dr Scott Gottlieb, authored a blog post on 9 May 2018 discussing the Spring 2018 Unified Agenda of Federal Regulatory and Deregulatory Actions1, which provides federal agencies with the opportunity to update the American…
The Republic of Korea has proposed an amendment1 to its Regulation on standard specification of medical devices. The amendment would harmonise Korea’s standard specification for self-test blood glucose monitoring systems with ISO 15197: 2013, In vitro diagnostic test systems –…
The US Food and Drug Administration (FDA) has announced the addition, withdrawal, correction and revision of certain consensus standards that the Agency will recognise for use in pre-market reviews and other requirements for devices. Standards contained in the latest list,…
The Food and Drug Administration (FDA) has released guidance entitled, Mitigating the Risk of Cross-Contamination from Valves and Accessories Used for Irrigation through Flexible Gastrointestinal Endoscopes1,2. This guidance highlights the cross-contamination risk posed by specific practices and types of irrigation…
In the final quarter of 2016, Health Canada issued an update to the Therapeutic Products Directorate’s (TPD’s) List of Recognized Standards for Medical Devices1. The changes consist of the addition of nine new standards, nine new editions of currently-recognised standards…
Introduction The world of laboratory testing is becoming more complicated and more complex, with genetic testing at the forefront. At the same time, global economies have changed and health insurance is now radically different with the passing of the Affordable…
Introduction The original guidance from the US Food and Drug Administration (FDA) on the biological evaluation of medical devices was The Blue Book Memorandum #G95-1, Use of International Standard ISO-10993, ‘Biological Evaluation of Medical Devices Part 1: Evaluation and Testing’,…
A draft Commission Decision has been developed1 to update the Common Technical Specifications, as set out in Article 5.3 of Directive 98/79/EC, for certain in vitro diagnostic medical devices (IVDs) according to the current state-of-the-art. These IVDs are hepatitis C…
Regulatory authority Article 3 of the Pharmaceutical Affairs Act (PAA)1 authorised the establishment of the Taiwan Food and Drug Administration (TFDA) in 2010 within the Ministry of Health and Welfare (MoHW) to administer ‘medicaments’. According to Article 4 of the…
On 21 June 2017, the European Committee for Standardization (CEN), the European Committee for Electrotechnical Standardization (CENELEC) and the Eurasian Economic Commission (EEC) signed a joint Memorandum of Understanding to pave the way for closer collaboration on various aspects of…
Comments are being accepted until 21 August 2017 on a draft Egyptian standard that specifies the requirements for mounted spectacle lenses relative to the prescription order1. The requirements of draft Egyptian Standard ES 1225-2/2016, Ophthalmic optics – Mounted spectacle lenses,…
A list of standards has been drafted1 for use, on a voluntary basis, to demonstrate compliance of a medical device with the General Requirements for the Safety and Effectiveness of Medical Devices of the Eurasian Economic Union (EAEU), as well…
Comments are being accepted until 29 August 2017 on draft administrative measures for the supervision and management of networked medical devices in China1. The proposed requirements apply to those who operate networked medical devices and those who provide third-party platform…
The Association for the Advancement of Medical Instrumentation (AAMI) has published a new Technical Information Report (TIR) entitled, Risk Management of Radio-frequency Wireless Coexistence for Medical Devices and Systems (TIR 69)1. This TIR applies to medical devices and systems (also…
A revision has been proposed to part 6 of the Israeli Mandatory Standard SI 1268, which concerns the colour coding for identification of single-use hypodermic needles1. The draft standard revision adopts the international standard ISO 6009: 2016, Hypodermic needles for…
A period of public consultation has been held on the Essential Principles for the safety and performance of medical devices that have been drafted1 to support the Medical Devices Rules, 2017, which are due to come into force on 1…
On 28 September 2017, the China Food and Drug Administration published1 the following medical device industry standards with an implementation date of 1 October 2018: YY/T 0661-2017, Surgical implants – Semi-crystalline polylactide polymers and copolymer resins; YY/T 1141-2017, General requirements…
On 9 October 2017, the China Food and Drug Administration published five technical review guidelines for registration1: Guiding principles for the technical examination of the registration of enzyme/enzyme-labelled analysers/instruments; Guidelines for the technical examination of the registration of single-use electrocardiogram…
