The materials used in medical devices, particularly those which are designed to be implantable or used in invasive procedures, must be carefully evaluated for safety and that evaluation documented in the premarket submission for the device. Some materials present...
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Updates on Modernization of the New Drugs Regulatory Program
We’ve already seen several updates on the FDA’s activities to modernize their operations, including updates to the web site structure and format, the April announcement of the CDRH reorganization (see this post), and a new CDER web page for FDA-Track (see this post)....
Draft Guidance on Enhancing Clinical Trial Populations
Under the FDA Reauthorization Act of 2017, the FDA received a mandate to promote practices that lead to clinical trials better reflecting the population most likely to use the drug. Based on discussions at a public meeting held in April 2018, CDER’s Office of Medical...
How to Study and Market Your Device
Have you been wondering how to start planning the regulatory process for your proposed medical device? CDRH offers this web page showing the 5 steps of how to study and market your device, and it’s an ideal first step for the new device sponsor. It shows the 5 steps...
ICH Guidance on Bioanalytical Method Validation
Drug regulation is a global effort, with country specific agencies each with their own unique perspective on the regulatory challenges within their own borders. There is also an international group known as the ICH (International Council for Harmonisation of Technical...
Bioanalytical Method Validation
The FDA publishes guidance documents to aid the medical products industry and the public in understanding and applying the regulations and requirements for pharmaceutical and medical device marketing approval. Supplemental information (in the form of Q&A guidance,...
Upcoming Public Meetings on Medical Devices
The FDA has scheduled two public meetings, one in July and one in September, to obtain feedback related to medical device communications technologies. The first will be July 17th and is co-hosted by the Networking and Information Technology Research and Development...
Expanded Access Program for Medical Devices
Readers of this blog will recall my earlier posts (here and here) on expanded access programs which enable physicians of patients with critical and life-threatening conditions options to treat their patients with pre-approval medicines outside of a clinical trial...