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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Yesterday (19 September 2023) the U.S. Food and Drug Administration (FDA) released two draft guidance "Regulatory Considerations for...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](https://static.wixstatic.com/media/nsplsh_453363554d4e4263424363~mv2.jpg/v1/fill/w_1330,h_1000,fp_0.50_0.50,q_30,blur_30,enc_avif,quality_auto/nsplsh_453363554d4e4263424363~mv2.jpg)
![USFDA Guidance: Premarket Notification [510(k)] Submissions](https://static.wixstatic.com/media/nsplsh_453363554d4e4263424363~mv2.jpg/v1/fill/w_1596,h_1200,fp_0.50_0.50,q_90,enc_avif,quality_auto/nsplsh_453363554d4e4263424363~mv2.jpg)
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
USFDA Guidance: Qualification of Medical Device Development Tools
Today (17 July 2023) the USFDA's Center for Devices and Radiological Health (CDRH) released final guidance on "Qualification of Medical...
Sharan Murugan
Jul 17, 20232 min read
MHRA Med Dev Guidance: In-Vitro Diagnostic Medical Devices on Legislation
Earlier today (17 July, 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "The...
Sharan Murugan
Jul 17, 20231 min read
Australia's TGA: Reclassification of Surgical Mesh, Spinal Implants & Completing a Notification Form
Recently on 27th June, 2023 Australia's Therapeutic Goods Administration (TGA) released multiple guidances on the "Reclassification of...
Sharan Murugan
Jul 2, 20232 min read
UK MHRA MD Guidance: Borderlines with Medical Devices & Other Products in Great Britain
Yesterday(01 July 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidelines on the "Borderlines...
Sharan Murugan
Jul 2, 20231 min read
UK MHRA Guidance: Clinical Trials for Medicines: Apply for Authorisation in the UK
Yesterday (27 June 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Clinical Trials...
Sharan Murugan
Jun 27, 20231 min read
USFDA Guidance: Pilot Program Oncology Drug Products & In Vitro Diagnostic Tests
Earlier today (20 June, 2023) the United States Food & Drug Administration's Center for Devices and Radiological Health, Center for Drug...
Sharan Murugan
Jun 20, 20231 min read
USFDA Guidance: Content of Premarket Submissions for Device Software Functions
Last Wednesday (14 June 2023) the United States Food & Drug Administration's Center for Devices and Radiological Health, Center for...
Sharan Murugan
Jun 17, 20231 min read
Philippines FDA: Guidelines on the Application for License to Operate
Yesterday (6 June 2023) the Philippines Food and Drug Administration (FDA) released an updated draft guideline "Guidelines on the...
Sharan Murugan
Jun 6, 20231 min read
Australia's TGA: Guidance on Regulation of Software based Medical Devices
Recently on 2nd June, 2023 Australia's Therapeutic Goods Administration (TGA) released guidance on the "Regulation of Software based...
Sharan Murugan
Jun 4, 20231 min read
USFDA Guidance: Medical Device Submissions "The Q-Submission Program"
Last Friday (02 June 2023) the United States Food & Drug Administration's Center for Devices and Radiological Health and Center for...
Sharan Murugan
Jun 4, 20231 min read
Swiss Medic Guidance: Minimising the Risk of TSE and Authorisation of Radiopharmaceuticals
Swissmedic, the Swiss Agency for Therapeutic Products, published an updated guidance document on (26 May 2023) the "Guidance document...
Sharan Murugan
May 28, 20232 min read