FDA launches Coronavirus Treatment Acceleration Program (CTAP). But can CTAP result in lower quality products? – what it means for the biotech and pharma industry?
CTAP – a step towards acceleration of therapies for COVID 19 After the emergence of COVID 19, FDA began working wi
What are medical device companies doing during the lockdown?
In an attempt to flatten the curve of COVID-19, many countries implemented lockdown policies. People are allowed to leav
As a Medical Device Company what can you do to help during the COVID 19 pandemic? – Here’s what –
Various benefits and flexibilities for Medical Device Manufacturers have been recently introduced. It’s impressive to
FDA has stopped Inspections
FDA appreciates product firms for non-violation of its rules and regulations and continues to be in contact with firms d
FDA grants the EUA authorization for Abbott RealTime SARS-CoV-2 assay – COVID – 19
As we all are aware, the FDA declared a healthcare emergency that calls for Emergency Use Authorization of medical devic
Is EU-MDR coming later?
EU MDD to MDR – A major change Medical Device Directive (MDD) which is in action now and will shortly be superse
A great opportunity for companies creating monitoring devices #digitalhealth.
Importance of remote monitoring devices during COVID19 pandemic. Given that these devices allow patients to timely get t
What is the classification of my software?
AI/ML changing the medical device industry Artificial Intelligence/Machine Learning based Software has revolutionized th
Say goodbye to the long hours of printing – New FDA eCopy Program
An eCopy is an electronic version of a medical device submission on a CD, DVD, or flash drive, and is accompanied by a p
AI/ML-based Software as a Medical Device (SaMD)-An urge for perfection
As rightly said, “Perfection is not attainable, but if we chase perfection we can catch excellence.” The urge to cre
Quality Objectives – Driving Improvements
Learn about the importance of Quality Objectives (QO).
510(k) Premarket Notification – A Passport for Market Entry
A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe.
Are Breast Implants Safe?
In recent times, there has been a growing concern related to the safety of breast implants.
Software Precertification Program: An Innovative Approach to Expedite Patient Access for SaMD
The Software Pre-Cert Program is a pathway is more visible than the current model to assess the safety and effectiveness
PATIENT PREFERENCE INFORMATION- THE TWITTER OF FDA(STREAMLINING PATIENT FEEDBACKS)
Patient inputs have always remained the core for healthcare systems, healthcare professionals and manufacturers.
FDA – Medical Devices Advisory Committee
Medical Devices Advisory Committee consists of 18 panels with a maximum of 159 standing members.
IEC 60601-1 Evolution of Electrical Safety standards to match Device Development
Standards are considered as an integral part of the product design and development.
De Novo paving the path for Technological Advancements
De Novo classification is not just a device reclassification process for medical devices but it is an application also.
CLIA Database: A Centralized Database of Clinical Tests & Instruments
Diagnosis plays a vital role in curing a disease.
17 years Journey – Surgical Mesh for Transvaginal Repair of Pelvic Organ Prolapse (POP)
On April 16, 2019, manufacturers of surgical mesh were ordered to stop selling their products.
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