21 CFR Chapter I Subchapter H – Medical Devices – Part 870 Cardiovascular Devices From Food and Drug Administration (FDA) 🇺🇸 A regulation titled "21 CFR Chapter I Subchapter H – Medical Devices – Part 870 Cardiovascular Devices". Metadata quality: Metadata quality: Data description filled Files documented License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 77.77777777777779/100 Updated 2 weeks ago Other (Public Domain) 0 reuses 0 favorites
Principle 11: Protection against radiation From Therapeutic Goods Administration (TGA) 🇦🇺 A medical device must be designed and produced in a way that ensures that the exposure of a patient, the user, or any other person, to radiation is minimised. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on July 11, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Research Involving Children as Subjects and Not Otherwise Approvable by an Institutional Review Board: Process for Referrals to Food and Drug Administration and Office for Human Research Protections: Draft Guidance for Institutional Review Boards, Investigators, and Sponsors From Food and Drug Administration (FDA) 🇺🇸 A draft guidance document outlines the process for referring research involving children to the FDA and OHRP, focusing on pediatric product development. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on April 11, 2024 Other (Public Domain) 0 reuses 0 favorites
The Innovative Devices Access Pathway (IDAP) From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 The Innovative Devices Access Pathway (IDAP) pilot is designed to accelerate the development of innovative medical devices that meet an unmet clinical need in the NHS and support their integration into the UK market. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on February 29, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
European medical device regulations From Ministry of Health (Italy) (MDS) 🇮🇹 Medical device sector is of great importance in healthcare in Europe, contributing to the improvement of the level of health protection through the development of innovative solutions for diagnosis, prevention, treatment and rehabilitation. Since the early 2020s, due to the SARS-CoV-2 pandemic,… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on December 12, 2023 Creative Commons Attribution 3.0 0 reuses 0 favorites
Reporting system for in vitro diagnostic medical devices From Ministry of Health (Italy) (MDS) 🇮🇹 The Ministry of Health carries out the activities of monitoring and investigating reports from healthcare professionals and manufacturers. On Sept. 28, 2022, Legislative Decree No. 138 of Aug. 5, 2022 , came into force, which in Article 13 provides fulfillments for manufacturers of in vitro… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on July 3, 2023 Creative Commons Attribution 3.0 0 reuses 0 favorites
The Medical Devices (Amendment) (Great Britain) Regulations 2023 From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 These Regulations amend the Medical Devices Regulations 2002 (S.I. 2002/618) (“the 2002 Regulations”) to extend the periods for which certain medical devices that comply with EU legislation can be placed on the market in Great Britain. The 2002 Regulations were made under section 2(2) of the… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on June 9, 2023 Open Government Licence 3.0 (United Kingdom) 0 reuses 0 favorites
Protection of Human Subjects: Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) Through an Expedited Review Procedure: Guidance for Institutional Review Boards and Clinical Investigators From Food and Drug Administration (FDA) 🇺🇸 This document provides guidance for Institutional Review Boards and Clinical Investigators on the expedited review procedure for research involving human subjects. Topics covered include Good Clinical Practice (GCP). Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on March 24, 2023 Other (Public Domain) 0 reuses 0 favorites
ZL000_00_024e_WL Guidance document Document protection HMV4 From Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇭 A guidance document on document protection for HMV4. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 44.44444444444444/100 Updated on January 1, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Protection of Human Subjects and Institutional Review Boards From Food and Drug Administration (FDA) 🇺🇸 Document number 2022-21088. The Food and Drug Administration (FDA or Agency) is proposing to amend its regulations to modernize, simplify, and enhance the current system for oversight of FDA-regulated human subject research. This proposed rule, if finalized, would harmonize certain sections of… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on September 28, 2022 Other (Public Domain) 0 reuses 0 favorites
Response letter from the Comprehensive Department of the State Drug Administration on the management attributes of medical radiation protection sprays From National Medical Products Administration (NMPA) 🇨🇳 FGWJ-2022-148 Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on April 29, 2022 Other (Public Domain) 0 reuses 0 favorites
Medical Device De Novo Classification Process From Food and Drug Administration (FDA) 🇺🇸 Document number 2021-21677. The Food and Drug Administration (FDA) is issuing a final rule to establish requirements for the medical device De Novo classification process under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This final rule establishes procedures and criteria related to… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on October 5, 2021 Other (Public Domain) 0 reuses 0 favorites
The Medicines and Medical Devices Act 2021 (Commencement No. 1 and Transitional and Savings Provision) Regulations 2021 From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 These Regulations commence certain provisions of the Medicines and Medical Devices Act 2021 (‘the Act’) on 26th May 2021. Regulation 2 brings the whole of Chapter 3 of Part 4 of the Act (enforcement), apart from section 31 (civil sanctions), into force, along with sections 39 and 40 (disclosure of… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on May 24, 2021 Open Government Licence 3.0 (United Kingdom) 0 reuses 0 favorites
Medicines and Medical Devices Act 2021 From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 An Act to make provision about a Commissioner for Patient Safety in relation to human medicines and medical devices; confer power to amend or supplement the law relating to human medicines, veterinary medicines and medical devices; make provision about the enforcement of regulations, and the… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on February 11, 2021 Open Government Licence 3.0 (United Kingdom) 0 reuses 0 favorites
Adverse Event Reporting to IRBs — Improving Human Subject Protection: Guidance for Clinical Investigators, Sponsors, and IRBs From Food and Drug Administration (FDA) 🇺🇸 This document provides guidance for clinical investigators, sponsors, and IRBs on improving human subject protection in adverse event reporting. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on May 6, 2020 Other (Public Domain) 0 reuses 0 favorites
Prospective Manufacturers of Barrier Devices Used During Oral Sex for STD Protection From Food and Drug Administration (FDA) 🇺🇸 A guidance document for manufacturers of barrier devices used during oral sex to protect against STDs. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on March 24, 2020 Other (Public Domain) 0 reuses 0 favorites
Coronary and Carotid Embolic Protection Devices - Premarket Notification [510(k)] Submissions : Guidance for Industry and FDA Staff From Food and Drug Administration (FDA) 🇺🇸 This document provides guidance for industry and FDA staff on premarket notification submissions for coronary and carotid embolic protection devices. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on March 20, 2020 Other (Public Domain) 0 reuses 0 favorites
Ordinance of 27 February 2019 to the Federal Act on Protection against the Risks associated with Non-Ionising Radiation and with Sound (O-NIRSA) From Swiss Federal Council 🇨🇭 The document is an ordinance titled "Ordinance of 27 February 2019 to the Federal Act on Protection against the Risks associated with Non-Ionising Radiation and with Sound (O-NIRSA)". Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on February 27, 2019 Other (Non-Commercial) 0 reuses 0 favorites
Medical Device De Novo Classification Process From Food and Drug Administration (FDA) 🇺🇸 Document number 2018-26378. The Food and Drug Administration (FDA) proposes to establish requirements for the medical device De Novo classification process under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The proposed requirements establish procedures and criteria related to requests for… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on December 7, 2018 Other (Public Domain) 0 reuses 0 favorites
Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices From Food and Drug Administration (FDA) 🇺🇸 Document number 2018-03244. The Food and Drug Administration (FDA or we) is amending its regulations on acceptance of data from clinical investigations for medical devices. We are requiring that data submitted from clinical investigations conducted outside the United States intended to support an… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on February 21, 2018 Other (Public Domain) 0 reuses 0 favorites