The National Health Surveillance Agency (ANVISA) has published changes1 to Normative Instruction IN 03/20152 on the grouping of in vitro diagnostic medical devices (IVDs) for the purposes of product registration. IN 03/2015 regulates Resolution RDC No 36/20153, which deals with…
The National Health Surveillance Agency (ANVISA) has extended1 a provisional measure adopted in 2018 to permit the reuse of devices used in cardiac procedures while new rules on the subject are undergoing public consultation (see previous article). This extension, which…
A public consultation on a draft Technical Regulation1 that sets out formal criteria for determining whether a medical device should be for single use only or whether it can be reused, as well as information that should be considered on…
From 2 May 2019, medical devices and in vitro diagnostic devices (IVDs) of risk Class I will no longer have to undergo full registration and instead will follow a simplified notification procedure1. Applications and technical dossiers will still need to…
Controls have been introduced for the manufacture and/or import of sunglasses into Argentina, as well as for sunglasses destined for international trade1. Sunglasses are defined as glasses and filters of zero rated power (i.e. non-prescription) that protect against solar radiation.…
A Provision has been published1 that sets out the process for requesting authorisation from the National Medical Products Directorate for the importation of medical products, including used medical products and in vitro diagnostics (IVDs). Applicants must use the Platform of…
In an effort to ensure that servicing activities are clearly distinguished from remanufacturing, and that all stakeholders understand the differences, the National Electrical Manufacturers Association (NEMA) has published NEMA/MITA RMD P1-2019, Considerations for Remanufacturing of Medical Imaging Devices1. This document…
On 8 March 2019, the temporary extension to the Global Unique Device Identification Database (GUDID) grace period came to an end, and the grace period was returned to the original seven days1. According to the GUDID guidance document2, the GUDID Device…
On 14 March 2019, 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: 0511. These standards are intended to help…
Comments are being accepted until 3 June 2019 on a proposed framework that would allow for modifications to artificial intelligence and machine learning (AI/ML) algorithms to be made from real-world learning and adaptation, while still ensuring that the safety and…
A draft guidance document entitled Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol has been published1,2 to set out proposed recommendations for what manufacturers should include in their pre-market submissions for devices containing nitinol (an alloy of nickel…
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)…
The Food and Drug Administration is soliciting comments on a draft guidance for industry entitled A Risk-Based Approach to Monitoring of Clinical Investigations: Questions and Answers1,2. The draft guidance provides information to sponsors on risk-based approaches to monitoring of investigational…
Comments are being accepted until 28 May 2019 on a draft guidance document1,2 that describes how section 704(h)(1) of the Federal Food, Drug and Cosmetic Act – which was added by section 702(a) of the FDA Reauthorization Act of 2017…
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 draft guidance has been issued1,2 that, when finalised, will provide industry with clear information on ways to prepare, plan and work with the Food and Drug Administration (FDA) to ensure voluntary recalls are initiated properly and promptly. The draft…
In order to fulfil a requirement under the FDA Reauthorization Act of 2017, a draft guidance on the provision of non-binding feedback after certain Food and Drug Administration (FDA) inspections of device establishments has been circulated for comment1,2. The draft…
Comments are being sought until 7 May 2019 on a draft guidance that presents the Food and Drug Administration’s current thinking on principles for pre-market review of combination products, including how to determine which type of pre-market submission is appropriate1,2.…
Final guidance has been published1,2 to assist drug sponsors and device manufacturers who are planning to coordinate development of new antimicrobial drugs and Antimicrobial Susceptibility Test (AST) devices such that the AST device could be cleared either at the time…
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…
On 5 February 2019, The Least Burdensome Provisions: Concept and Principles Guidance for Industry and Food and Drug Administration Staff was published1,2. This guidance, which supersedes The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles…
New guidance entitled Evaluation of Devices Used with Regenerative Medicine Advanced Therapies; Guidance for Industry1,2 provides manufacturers, applicants and sponsors involved in the development of regenerative medicine therapies with the Food and Drug Administration’s current thinking on the evaluation of…
A new guidance document has been released1,2 as part of the Food and Drug Administration’s (FDA’s) ongoing efforts to strengthen and modernise the process for issuing public warnings about voluntary recalls and for notification of recalls of FDA-regulated products. The…
An immediately-in-effect guidance for industry entitled Compliance Policy for Combination Product Postmarketing Safety Reporting1,2 has been updated. This guidance outlines the Food and Drug Administration’s (FDA’s) compliance policy for Combination Product Applicants and Constituent Part Applicants and activities under Title…
On 8 February 2019, the Food and Drug Administration (FDA) published a final guidance document outlining its intent to exempt certain unclassified medical devices from the pre-market notification (510(k)) requirements1. This guidance updates and supersedes the Intent to Exempt Certain…
On 21 February 2019, compliance with the final rule on human subject protection; acceptance of data from clinical investigations for medical devices became compulsory1. To assist stakeholders in the compliance process, the Food and Drug Administration has released specific resources…
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,…
A list of accessories that are deemed suitable for classification into Class I, as required by the FDA Reauthorization Act of 2017 (FDARA), has been finalised and will take effect on 13 May 20191. When preparing this list, the Food…
Comments are being accepted until 6 May 2019 on a proposal to exempt a subset of flow cytometer instruments from pre-market notification (510(k)) review, subject to certain conditions and limitations1. These devices are currently Class II devices under §864.5220 of…
The Food and Drug Administration (FDA) has announced three new efforts to protect patients better from the malfunctions, injuries and deaths associated with surgical staplers for internal use and implantable staples. Firstly, the Agency has proposed up-classifying surgical staplers for…
A device to detect and identify microorganisms and associated resistance marker nucleic acids directly in respiratory specimens has been classified into Class II (special controls) and the classification has been codified by the addition of §866.3985 to Title 21 of…
The Food and Drug Administration (FDA) has classified the transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions into Class II1 and developed the following special controls: Performance testing must demonstrate electromagnetic compatibility, electrical safety and thermal…
The auto titration device for oral appliances has been classified into Class II (special controls) through the addition of §872.5571 to Title 21 of the Code of Federal Regulations1. An auto titration device for oral appliances is a prescription, home-use…
Software applications for contraception, which provide user-specific fertility information for preventing a pregnancy, have been classified into Class II (special controls) through the addition of §884.5370 to Title 21 of the Code of Federal Regulations1. This device type includes an…
On 1 May 2019, a final rule1 came into force to classify in vitro diagnostic devices for Bacillus species detection into Class II (special controls), and to continue to require a pre-market notification (510(k)) to provide a reasonable assurance of…
Posterior cervical screw systems (product code NKG) have been classified1 into Class II (special controls) because the Food and Drug Administration believes that special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness for…
The Food and Drug Administration has classified the ventilatory electrical impedance tomograph into Class II (special controls)1. A ventilatory electrical impedance tomograph is a prescription non-invasive, non-radiological ventilatory device that provides an assessment of local impedance variation within a cross-section…
The Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) is undergoing a major reorganisation1 to enable it to realise more fully its public health mission and vision, and to allow it to adapt to future organisational, regulatory…
Dr Norman Sharpless has taken over as acting Commissioner of the Food and Drug Administration (FDA)1 following the unexpected resignation of Scott Gottlieb after only two years in office2. Dr Sharpless had been Director of the National Cancer Institute since October…
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
An experience-based consultation is being held on the Draft Health Canada IMDRF ToC [International Medical Device Regulators Forum Table of Contents] for Medical Device Applications Guidance1. This guidance is intended to assist manufacturers and regulatory correspondents in understanding the structure,…
Input has been sought from interested public parties, healthcare professionals and medical device manufacturers on a Draft Guidance Document for Software as a Medical Device (SaMD)1, which helps to explain which products qualify as SaMD, as well as how SaMD…
Health Canada has published final regulations that allow for the public release of non-confidential, non-personal clinical information (e.g. study reports and clinical trial results) on drugs1 and medical devices2. These regulations are one of the main transparency measures introduced by…
On 1 March 2019, the Regulations Amending the Medical Devices Regulations (Updating ISO Standard)1 amended the Medical Devices Regulations by replacing ‘13485:03’ with ‘13485:16’ in paragraphs 32(2)(f), 32(3)(j) and 32(4)(p). The Medical Devices Regulations require manufacturers to submit a Quality Management…
On 1 April 2019, Health Canada’s revised fee structure came into effect1. In line with Section 4 of the 2011 Fees in Respect of Drugs and Medical Devices Regulations, every fee outlined by the Regulations must be increased annually by…
At a special meeting of the European Council, leaders of the other 27 European Union (EU) Member States agreed to extend Article 50 (the UK’s exit from the EU) until 31 October 20191. Their decision was taken in agreement with…
Guidance on virtual manufacturing of medical devices (formerly own brand labelling) has been updated1 to cover manufacturers in conformity with Regulation (EU) 2017/745 and Regulation (EU) 2017/746, as well as Directives 93/42/EEC and 98/79/EC. Previously the UK had accepted Summary…
Amended ordering requirements for Certificates of Free Sale (CFS) came into effect on 13 February 20191 to take account of experience gained with the new issuing process that was introduced during 2018. Problems had been unexpectedly common, especially with grouping medical devices,…
According to Order No 2945/2019, the services and establishments of the National Health Service (Serviço Nacional de Saúde, SNS) may only purchase medical devices that have been coded by the National Authority for Medicines and Health Products (INFARMED) and that…
A new law has been drafted that, if implemented, would obligate healthcare institutions, patients and manufacturers of implantable medical devices to participate in a German Implant Register (EDIR)1. All implantable medical devices would have to be listed in a device…
