USFDA M.D Guidance: Med Dev Associated with Weight Loss & Voluntary Improvement Program
USFDA Guidance: Premarket Notification [510(k)] Submissions
Australia's TGA: Reclassification of Medical Devices & Variations to Prescription Medicines
USFDA Guidance: Informed Consent Guidance for IRBs, Clinical Investigators, & Sponsors
USFDA Guidance: Recommended Acceptable Intake Limits for Nitrosamine DS-Related Impurities
Canada HC Guidance: Nitrosamine Impurities in Medications
USFDA Med Dev Guidance: On Opioid Use Disorder & Hydrogen Peroxide-Based Contact Lens Care Products
UK MHRA: Guidance on Renewing Marketing Authorisations & Implementation of Med Dev. Future Regime
USFDA Guidance: Qualification of Medical Device Development Tools
MHRA Med Dev Guidance: In-Vitro Diagnostic Medical Devices on Legislation
Australia's TGA: Reclassification of Surgical Mesh, Spinal Implants & Completing a Notification Form
UK MHRA MD Guidance: Borderlines with Medical Devices & Other Products in Great Britain
UK MHRA Guidance: Clinical Trials for Medicines: Apply for Authorisation in the UK
USFDA Guidance: Pilot Program Oncology Drug Products & In Vitro Diagnostic Tests
USFDA Guidance: Content of Premarket Submissions for Device Software Functions
Australia's TGA: Guidance on Regulation of Software based Medical Devices
USFDA Guidance: Medical Device Submissions "The Q-Submission Program"
Swiss Medic Guidance: Minimising the Risk of TSE and Authorisation of Radiopharmaceuticals
USFDA Guidance: Covariates RCT, Non-Clinical Performance Assessment of Tissue & Efficacy Endpoints
Malaysia's Medical Device Authority: Guideline on Medical Face Mask and Respirator