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Switzerland's SwissMedic: Guidance on Formal Requirements

On 15 November 2023, Switzerland's Swissmedic released an updated guidance on "Formal Requirements" which serves as a resource for...

Sharan Murugan

Nov 15, 20232 min read

MHRA Guidance: Common Issues Identified during Clinical Trial Applications

Yesterday (06 November 2023) the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Common...

Sharan Murugan

Nov 7, 20231 min read

USFDA MD Guidance: Enforcement Policy for Clinical Electronic Thermometers

Last Friday (03 November 2023) the U.S. Food and Drug Administration (FDA) released two draft guidance "Enforcement Policy for Clinical...

Sharan Murugan

Nov 5, 20231 min read

USFDA Guidance: Supplements for Approved Premarket Approval or Humanitarian Device Exemption

Today (02 November, 2023) the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research Center for Devices and...

Sharan Murugan

Nov 2, 20231 min read

TGA Guidance: General Dossier Requirements

Recently on 27th October, 2023 Australia's Therapeutic Goods Administration (TGA) released an updated guidance on the "General Dossier...

Sharan Murugan

Oct 31, 20231 min read

UK MHRA: Guidance on Software and Artificial Intelligence (AI) as a Medical Device

Earlier today (25 October 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated Guidance on "Software...

Sharan Murugan

Oct 25, 20231 min read

USFDA MD Guidance: Enforcement Policy for Non-Invasive Remote Monitoring Devices

The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health released a final guidance "Enforcement Policy for...

Sharan Murugan

Oct 23, 20231 min read

USFDA MD Guidance: Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices

Recently (10th October 2023) the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health released multiple...

Sharan Murugan

Oct 14, 20231 min read

USFDA MD Guidance: AST System Devices, Technical Considerations & Electronic Submission Template

Recently (29th September 2023) the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health released multiple...

Sharan Murugan

Oct 2, 20232 min read

USFDA MD Guidance: Cybersecurity-Quality System Considerations & Content of Premarket Submissions

The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health released a final guidance "Cybersecurity in...

Sharan Murugan

Oct 2, 20231 min read

EC Q&A Guidance: Questions & Answers: Clinical Trials Regulation

Recently this Friday (29-Sepetember, 2023), the European Commission's Clinical Trials Coordination and Advisory Group released an updated...

Sharan Murugan

Oct 1, 20232 min read

MHRA MD Guidance: Innovative Devices Access Pathway (IDAP) & How to Notify Clinical Investigation

Recently the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "The Innovative Devices Access...

Sharan Murugan

Sep 25, 20232 min read

USFDA Guidance: Conduct of Clinical Trials of Medical Products During Major Disruptions

Today (21 September 2023) CDER, along with the FDA Center for Biologics Evaluation and Research, Center for Devices and Radiological...

Sharan Murugan

Sep 21, 20231 min read

USFDA Guidance: Regulatory Considerations for Prescription Drug Use-Related Software

Yesterday (19 September 2023) the U.S. Food and Drug Administration (FDA) released two draft guidance "Regulatory Considerations for...

Sharan Murugan

Sep 20, 20232 min read

USFDA M.D Guidance: Med Dev Associated with Weight Loss & Voluntary Improvement Program

Recently (14th September, 2023) the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health released multiple...

Sharan Murugan

Sep 19, 20232 min read

USFDA Guidance: Premarket Notification [510(k)] Submissions

The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health and Center for Biologics Evaluation and Research...

Sharan Murugan

Sep 10, 20232 min read

Australia's TGA: Reclassification of Medical Devices & Variations to Prescription Medicines

Yesterday (21-August-2023) Australia's Therapeutic Goods Administration (TGA) released multiple guidances on the "Reclassification of...

Sharan Murugan

Aug 22, 20232 min read

USFDA Guidance: Informed Consent Guidance for IRBs, Clinical Investigators, & Sponsors

The U.S. Food and Drug Administration (FDA) released its final guidance this Tuesday (15 August 2023), "Informed Consent: Guidelines for...

Sharan Murugan

Aug 17, 20231 min read

USFDA Med Dev Guidance: On Opioid Use Disorder & Hydrogen Peroxide-Based Contact Lens Care Products

Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder Last week (26 June, 2023) the United States Food &...

Sharan Murugan

Jul 30, 20232 min read

UK MHRA: Guidance on Renewing Marketing Authorisations & Implementation of Med Dev. Future Regime

Guidance on Renewing Marketing Authorisations Recently (28, July 2023) the UK's Medicines and Healthcare Products Regulatory Agency...

Sharan Murugan

Jul 30, 20231 min read