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This page provides a simple browsing interface for finding entities described by a property and a named value. Other available search interfaces include the page property search, and the ask query builder.
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- Reference:USA U.S. Code Title 21 30-Sep-2023 § 321 (f) +
- Reference:USA U.S. Code Title 21 30-Sep-2023 § 321 (i) +
- Reference:USA U.S. Code Title 21 30-Sep-2023 § 321 (h) +
- Reference:USA 21 CFR Part 809 06-May-2024 § 809.3 (a) +
- Reference:USA FD&C Act - Federal Food, Drug, and Cosmetic Act 30-Sep-2023 Sec 510 (k) +
- Reference:USA FD&C Act - Federal Food, Drug, and Cosmetic Act 30-Sep-2023 Sec 512 (f) +
- Reference:USA FD&C Act - Federal Food, Drug, and Cosmetic Act 30-Sep-2023 Sec 737 (8) +
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 51 +
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex VIII +
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 47 +
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex VIII +
- Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 6 +
- Reference:GBR Directive 93/42/EEC 11-Oct-2007 Article 9 +
- Reference:USA FD&C Act - Federal Food, Drug, and Cosmetic Act 30-Sep-2023 Section 513 +
- Reference:ICH ICH E8 Guideline R1 (2021) ANNEX: TYPES OF CLINICAL STUDIES +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - clinical trial Phases +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.21 +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.85 +
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex I +
- Reference:ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 3 +
- Reference:ICH ICH E8 Guideline R1 (2021) - +
- Reference:ICH ICH E8 Guideline R1 (2021) 3.3.5 +
- Reference:ICH ICH E9 Guideline 1998 III +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 9.1 +
- Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Overview of the Clinical Research Process +
- Reference:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 2. +
- Reference:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 4.1 +
- Reference:EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022 - +
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 62 Paragraph 1 +
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 62 Paragraph 3 +
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 74 +
- Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 82 +
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 58 Paragraph 1 – 3 +
