FDA expects that all data be reliable and accurate (see the “Background” section). CGMP regulations and guidance allow for flexible and risk-based strategies to prevent and detect data integrity issues. Firms should implement meaningful and effective strategies to manage their data integrity risks based on their process understanding and knowledge management of technologies and business models.
- Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence
- FDA DRAFT GUIDANCE Electronic Submission Template for Medical Device De Novo Requests
- Manual on borderline and classification for medical devices under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices
- Transição de ensaios clínicos para o Regulamento Europeu (complemento à Circular Informativa N.º 088/CD/100.20.200 de 04/09/2023)
- Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
- Q&A ON TRANSITIONAL PROVISIONS FOR PRODUCTS WITHOUT AN INTENDED MEDICAL PURPOSE COVERED BY ANNEX XVI OF THE MDR.
- European Commission Newsletter on medical devices | September 2023
- Good clinical practice (GCP) inspection procedures : ANNEX III TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP: COMPUTER SYSTEMS