A new compliance programme (7356.000) was launched in June 2020 for inspections of Center for Drug Evaluation and Research (CDER)- and Center for Devices and Radiological Health (CDRH)-led combination products1. This compliance programme focuses on inspections of combination product manufacturers…
Short glossary Article 117 of Regulation (EU) 2017/7451 on medical devices (the MDR) describes the requirements for the device part of drug/device combinations regulated as medicines. Rule 13 of Directive 93/42/EEC (the MDD) specifies the requirements for medical devices containing…
Guidance has been drafted to outline ways in which combination product sponsors can obtain feedback from the Food and Drug Administration (FDA) on scientific and regulatory questions1,2. The guidance also describes best practices to be followed by the FDA and…
Interested parties have until 18 February 2020 to comment on a draft guidance for industry entitled Bridging for Drug-Device and Biologic-Device Combination Products1,2. In this context, the term bridging refers to the process of establishing the scientific relevance of information…
Introduction Generally, borderline products by their nature do not belong clearly to a specific sector and it can therefore be difficult to identify the applicable regulatory framework. When a product does not fall within the definition of a medical device,…
A question-and-answer (Q&A) document on the implementation of Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices has been updated by the European Medicines Agency (EMA)1. This first revision focuses on aspects relating…
New guidance1,2 has been published to clarify how applicants of combination products (drug, device, biologic) can comply with the 2016 final rule on post-market safety reporting requirements (PMSR) for combination products. Although the PMSR regulations for drugs, devices and biological…
The European Commission has updated1 its manual on borderline and classification issues for medical devices to assist the national Competent Authorities in their decision-making processes. Version 1.22 of the manual includes the following new consensuses on borderline and classification issues:…
Public consultation is being held until 31 August 2019 on a draft Guideline on the quality requirements for drug-device combinations1 developed by the European Medicines Agency (EMA). The guideline provides advice on the documentation expected for drug-device combinations (DDCs) in…
Interested parties had until 29 April 2019 to comment on a proposal1 to introduce a new classification rule for invasive medical devices that administer medicines or biologicals by inhalation. At present, Australia classifies these devices as low risk (Class I)…
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 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…
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…
The European Commission has updated1 its manual on borderline and classification issues for medical devices to assist the national Competent Authorities in their decision-making processes. Version 1.21 of the manual includes the following new consensuses on borderline and classification issues: …
A question-and-answer (Q&A) document on the implementation of Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices has been published by the European Medicines Agency (EMA)1. This document provides practical considerations for the…
Introduction Around the world, medical devices have become an integral part of modern healthcare and even daily life. These advancements are largely due to an influx of innovative, digital technology that has changed the medical device environment. Telephones, watches and…
The European Commission has updated1 its manual on borderline and classification issues for medical devices to assist the national Competent Authorities in their decision-making processes. Version 1.20 of the manual includes the following new consensuses on borderline and classification issues: 25,…
A summary of classification decisions has been released for products at the medical device-drug-cosmetic interphase (MDDCI)1. For each product, the intended purpose/indication and mode of action is specified, along with the classification (e.g. medical device) and the relevant regulatory agency…
The Food and Drug Administration has reopened1 the comment period on two draft guidance documents from 2008 entitled: Coronary Drug-Eluting Stents--Nonclinical and Clinical Studies2; and Coronary Drug-Eluting Stents--Nonclinical and Clinical Studies Draft Companion Guidance Document3. The Agency is reopening the…
A final guidance entitled Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing has been published by the Food and Drug Administration (FDA)1,2. This guidance describes labelling and safety testing recommendations for medical devices that contain heparin,…
The compliance date for Global Unique Device Identification Database (GUDID) submission requirements of device constituents of co-packaged combination products assigned to the Center for Drug Evaluation and Research (CDER) for pre-market review has been extended by one year to 24 September…
In accordance with the statutory mandate of the 21st Century Cures Act, the Food and Drug Administration has published a proposed list of processes for single-entity and co-packaged combination products that can satisfy the current Good Manufacturing Practice (cGMP) requirements…
A public consultation, which ended on 16 July 2018, gave interested parties the opportunity to comment1,2 on proposals to amend the regulations relating to the classification of products as biological products, devices, drugs or combination products, and their assignment to…
The European Commission has updated1 its manual on borderline and classification issues for medical devices to assist the national Competent Authorities in their decision-making processes. Version 1.19 (April 2018) of the manual includes the following new consensuses on borderline and…
Introduction In recent years, the number of combination products entering the global market has grown significantly due to advances in medical technology as well as an increase in user demand. While these products hold great promise for the future of…
The draft Guideline for registration of drug-medical device and medical device-drug combination products was released in the final quarter of 2016 for a period of public consultation1. The draft guidance focuses on the dossier requirements and procedures for submission of…
The National Administration of Medicines, Food and Medical Technology (ANMAT) has stated1 that products for aesthetic use are to be subject to the sanitary registration requirements of Disposition 2318/02 (TO 2004). The reasons for this action are the frequent and…
A deadline of 13 April 2017 has been set for submitting comments on the draft guidance entitled How to Prepare a Pre-Request for Designation (Pre-RFD) before work begins on the final version of the guidance1. The Pre-RFD process allows sponsors…
Guidance entitled Current Good Manufacturing Practice [cGMP] Requirements for Combination Products1 has been published to provide background information on combination products, an overview of the 2013 document on cGMP requirements for combination products2, and the role of the lead Center…
The Food and Drug Administration (FDA) has published a final rule1 to describe the circumstances in which a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device or…
Regulations have been published to set out the specific post-marketing safety reporting requirements that apply to combination products in the USA1. These rules apply when two or more different types of regulated medical products (drugs, devices and/or biological products, referred…
On 19 May 2017, the Regulatory Committee on Medical Devices voted in favour1 of the draft Commission Implementing Decision2 on the qualification of cranberry products. According to the draft Decision, the group of products whose principal intended action, depending on…
New guidance has been issued1,2 by the Food and Drug Administration (FDA) to explain the Agency’s current thinking on approaches for classifying products as drugs and devices, and on certain additional product classification issues. This guidance combines and finalises two…
On 10 August 2017, Commission Implementing Decision (EU) 2017/1445 was published1 to confirm that the group of products whose principal intended action, depending on proanthocyanidins (PAC) present in cranberry extract (VacciniumMacrocarpon), is to prevent or treat cystitis, does not fall…
Introduction It is well recognised that the new Medical Device Regulation (EU) 2017/745 (MDR)1will have a significant impact on device manufacturers, Notified Bodies (NBs) and device Competent Authorities (CAs). However, it will also affect how the increasing number of drug/device…
Comments are being accepted until 15 February 2018 on a draft guidance document concerning the evaluation of devices used with Regenerative Medicine Advanced Therapies (RMATs)1,2. When finalised, it is hoped that this guidance will provide device manufacturers, applicants and sponsors…
A rule has been published that proposes1 delaying the effective date of certain portions of a final rule published in the Federal Register on 9 January 2017 concerning when products made or derived from tobacco are regulated as drugs, devices…
The European Commission has updated1 its manual on borderline and classification issues for medical devices to assist the national Competent Authorities in their decision-making processes. Version 1.18 (December 2017) of the manual includes the following new consensuses on borderline and…
Dates have been announced for the implementation and enforcement1 of the requirements specified in the Guideline for Registration of Drug-Medical Device and Medical Device-Drug Combination Products2. For unregistered combination products, the Guideline will apply to new registration applications submitted on…
An immediately-in-effect guidance for industry has been published entitled Compliance Policy for Combination Product Postmarketing Safety Reporting1,2. 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…
A final rule1 has been published that delays indefinitely the effective date of certain portions of a final rule published in the Federal Register on 9 January 2017 concerning when products made or derived from tobacco are regulated as drugs,…
Guidance on the classification of health products at the device-drug interface has been updated to reflect changes to the definition of a medical device introduced by Vanessa’s Law and to provide greater clarity to the description of Health Canada’s classification…
A reflection paper1 published in January 2018 responds to the increasing regulatory focus on quality, safety and performance aspects of devices integral to medicinal products, reflecting the growing complexity of some of these device components (e.g. auto-injectors, on-body pumps, and…
