The purpose of this guidance is to identify the types of decision support software functionalities that: (1) do not meet the definition of a device as amended by the Cures Act; (2) may meet the definition of a device but for which FDA does not intend to enforce compliance with applicable requirements of the FD&C Act, including, but not limited to, premarket clearance and premarket approval requirements; and (3) FDA intends to focus its regulatory oversight on.
- Framework for the Use of Digital Health Technologies in Drug and Biological Product Development
- Advancing regulatory science in the EU – mid-point report published
- Amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices
- Gestão de Risco no âmbito das Boas Práticas de Distribuição : “Formação muito bem conseguida com aplicabilidade prática”
- EVALUATION GUIDE FOR GMP REGULATORY COMPLIANCE PROGRAMME : Audit Checklist
- MDCG 2023-3: Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices
- Ongoing guidance development and deliverables of MDCG Subgroups – March 2023*
- Artificial Intelligence in Drug Manufacturing.