The Philippine Food and Drug Administration (Philippine FDA) has published a draft Circular for comments on Modes of Regulatory Inspection for Food and Drug Administration Regulated Health Product Establishments. The draft proposes a risk-based framework for determining whether regulatory inspections should be conducted on-site, remotely, or using a hybrid approach, while retaining on-site inspection as the primary mode.

On 25 September 2026, the U.S. Food and Drug Administration (FDA) issued draft guidance on Robotically-Assisted Surgical Devices – Premarket Submissions. The draft provides recommendations on premarket submission content, non-clinical testing, clinical evidence and labeling for certain robotically-assisted surgical devices (RASDs). It is intended to promote greater consistency in the information provided to FDA and facilitate the review of these complex systems.

On 18 September 2026, the U.S. Food and Drug Administration (FDA) issued draft guidance on the Electronic Submission Template for Premarket Approval Applications (PMAs). The draft describes FDA’s proposed approach to the electronic submission of specified PMA application and supplement types using the electronic Submission Template And Resource (eSTAR).