The U.S. Food and Drug Administration (FDA) is partnering with Health Canada to launch a joint electronic Submission Template and Resource (eSTAR) pilot. The joint pilot, announced on January 10th, 2023, will test the feasibility of allowing sponsors to submit medical device submissions to both regulatory bodies through the FDA’s eSTAR online portal. Requests for […]
The US Food and Drug Administration (FDA) published a draft guidance document in December 2021 outlining transition plans for medical devices currently marketed under Emergency Use Authorizations (EUAs) during the COVID-19 public health emergency (PHE). The FDA has issued EUAs for a vast array of medical devices during the pandemic including ventilators, infusion pumps, personal […]
The FDA’s Center for Devices and Radiological Health’s (CDRH) Office of Science and Engineering Labs (OSEL) is a part of FDA’s initiative to speed up medical device development and patient access to safe and effective medical devices by producing tools using innovative science in the assessment of new medical devices. A Catalog of Regulatory Science […]
Chutes and Ladders – Commercializing your medical device in the US market requires submitting marketing applications to the FDA to become an FDA Approved or Cleared Medical Device. The content of your FDA submission is determined by how your medical device is classified into one of three Classes (I, II, or II), based on the […]
Expert Advice from the 16th Annual Medical Device Coverage & Reimbursement Conference A medical device sponsor must feel like they have successfully climbed Mount Everest when they receive their approval from the FDA – but in reality, they’ve only reached the first Base Camp. There is still a challenging uphill climb before receiving the real […]
This blog gives a snapshot of what the FDA, Health Canada and the European Commission have put in place to fast-track COVID-19 related Medical Device approvals and provide quicker access to medical devices that deal with the COVID-19 outbreak.
Your Roadmap for Premarket Submissions Are you wondering how best to organize your test plans and reports to make them submission ready? Look no further. The FDA provides a roadmap to follow for your premarket submission in their new guidance, ‘Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions’.
Leveling the Playing Field with recent Draft Guidance Review and Update of Device Establishment Inspection Processes and Standards, a draft guidance document from the FDA, establishes uniform processes and standards for FDA’s Inspection Process of both domestic and foreign medical device firms. The FDA’s plan is outlined in a short, six-page document released March 29, […]
5 tips to a successful academic-industrial partnership Costs are rising for research so how do you maximize your biotech R&D budget? Form an academic-industrial partnership. Perhaps you are working on a disruptive technology and need an expert to assess that your assay is better than the accepted standard? Or maybe you’ve had a pet research […]