Review
Accepted on 27 Oct 2025
Discrepancies in Regulations in Post-Marketing Safety Surveillance of Drug-Device Combination Products in the EU and US: a Review
in Substance-Based Medical Devices
Frontiers in Drug Safety and Regulation
- 363 views
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21 articles
Review
Published on 17 Jan 2025
Integrating environmental effects in the benefit-risk assessment of therapeutic products: a proposal and example for sustainable health and healthcare
in Substance-Based Medical Devices
Frontiers in Drug Safety and Regulation
doi 10.3389/fdsfr.2024.1519142
- 2,897 views
- 1 citation
Original Research
Published on 16 Jan 2025
The safety and efficacy of neutral electrolyzed water solution for wound irrigation: post-market clinical follow-up study
in Substance-Based Medical Devices
Frontiers in Drug Safety and Regulation
doi 10.3389/fdsfr.2024.1402684
- 3,078 views
- 1 citation
Original Research
Published on 17 Sep 2024
Demonstrating the principal mechanism of action of medical devices intended for vaginal use on reconstructed human vaginal epithelium: the case of two hyaluronic acid-containing devices
in Substance-Based Medical Devices
Frontiers in Drug Safety and Regulation
doi 10.3389/fdsfr.2024.1445519
- 2,965 views
- 2 citations
Opinion
Published on 03 Apr 2024
Regulation 2017/745 on medical devices, two major innovations: 1) the physiological action of devices consisting of natural materials such as vegetal matrices; 2) the chemical-physical-mechanical action of devices made of “substances”, which as such are artificial derivatives
in Substance-Based Medical Devices
Frontiers in Drug Safety and Regulation
doi 10.3389/fdsfr.2024.1389406
- 2,356 views
- 1 citation
Review
Published on 04 Aug 2023
Mucoadhesive polymers in substance-based medical devices: functional ingredients or what else?
in Substance-Based Medical Devices
Frontiers in Drug Safety and Regulation
doi 10.3389/fdsfr.2023.1227763
- 8,880 views
- 16 citations
Editorial
Published on 31 May 2023
Editorial: Substance-based medical devices for human health: a challenge of efficacy, safety, and sustainability
in Substance-Based Medical Devices
Frontiers in Drug Safety and Regulation
doi 10.3389/fdsfr.2023.1222790
- 1,512 views
Methods
Published on 11 Apr 2023
Safety and efficacy of substance-based medical devices: Design of an in vitro barrier effect test
in Substance-Based Medical Devices
Frontiers in Drug Safety and Regulation
doi 10.3389/fdsfr.2023.1124873
- 2,397 views
- 2 citations
Review
Published on 24 Feb 2023
Gastrointestinal functional disorders can benefit from the use of medical devices made of substances
in Substance-Based Medical Devices
Frontiers in Drug Safety and Regulation
doi 10.3389/fdsfr.2023.1119353
- 2,324 views
- 2 citations
Policy and Practice Reviews
Published on 15 Dec 2022
Medicinal products, medical devices, or accessories of medical devices: How to qualify gases for spirometry?
in Substance-Based Medical Devices
Frontiers in Drug Safety and Regulation
doi 10.3389/fdsfr.2022.1089965
- 4,935 views
- 2 citations
Protocols
Published on 09 Dec 2022
A new platform for post-marketing surveillance and real-world evidence data collection for substance-based medical devices
in Substance-Based Medical Devices
Frontiers in Drug Safety and Regulation
doi 10.3389/fdsfr.2022.992359
- 6,345 views
- 10 citations
Perspective
Published on 07 Dec 2022
European Union Regulation on clinical trials and Regulation on medical devices: A common soil for future development
in Substance-Based Medical Devices
Frontiers in Drug Safety and Regulation
doi 10.3389/fdsfr.2022.1071620
- 4,482 views
- 1 citation
Correction
Published on 26 Oct 2022
Corrigendum: Substance-based medical devices made of natural substances: An opportunity for therapeutic innovation
in Substance-Based Medical Devices
Frontiers in Drug Safety and Regulation
doi 10.3389/fdsfr.2022.1054972
- 1,279 views
Original Research
Published on 10 Oct 2022
Effectiveness and tolerability of Poliprotect, a natural mucosal protective agent for gastroesophageal reflux disease and dyspepsia: Surveys from patients, physicians, and pharmacists
in Substance-Based Medical Devices
Frontiers in Drug Safety and Regulation
doi 10.3389/fdsfr.2022.969831
- 7,424 views
- 8 citations
Perspective
Published on 16 Sep 2022
New regulation on medical devices made of substances: Opportunities and challenges for pharmacological and toxicological research
in Substance-Based Medical Devices
Frontiers in Drug Safety and Regulation
doi 10.3389/fdsfr.2022.1001614
- 2,619 views
- 5 citations
Perspective
Published on 02 Sep 2022
Substance-based medical devices made of natural substances: An opportunity for therapeutic innovation
in Substance-Based Medical Devices
Frontiers in Drug Safety and Regulation
doi 10.3389/fdsfr.2022.998114
- 4,896 views
- 7 citations