Global Medical Device Podcast powered by Greenlight Guru Overcoming Submission Deficiencies due to Biocompatibility
What are submission deficiencies due to biocompatibility and how do medical device companies overcome them in trials, studies, and regulatory post-market surveillance?
In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Chris Parker, Associate Department Head of In-Vivo Biocompatibility at Toxikon Corporation on how to overcome and prevent those submission deficiencies.
Some of the highlights of this episode include:
- When a manufacturer puts their package together for a submission to the FDA, if it is not approved, then the FDA issues a deficiency or request for additional information due to a question or issue with some part of the submission.
- If a deficiency is issued, the FDA allows the manufacturer to handle it in one of two ways—either correct it through a memo/risk assessment or retest.
- It is better to be proactive rather than reactive when addressing a deficiency. A little bit of time upfront with the FDA will save a lot of time on the backend.
- Competition: When most medical devices are being developed, there is intent. Either it’s a completely new idea or existing product that another manufacturer offers that you want to build or improve upon.
- Prop 65 and new European regulations strive to keep out carcinogens, mutagens, reproductive toxins, and other compounds that at certain thresholds may be of concern and should not be included in devices or labeling is required.
- When it comes to quality, ISO standards and FDA regulations are in the best interest of the patient but may be a costly burden for the manufacturers. It takes units of a medical device to complete evaluations for biocompatibility testing.
- It takes days, months, or requires extensions for some companies to do remedial work and meet expectations when responding to a deficiency.
- Implement quality from the beginning with a quality management system (QMS) to understand expectations of standards, practices, and regulations.
Memorable quotes from Chris Parker:
“In a fair number of instances, there are cases where the FDA issues what we call a deficiency. It’s otherwise known as a request for additional information. But generally, what it is, is they have a question or an issue with some part of the submission.”
“Be proactive, not reactive because then a little bit of time upfront will save you a lot of time on the backend.”
“A lot of devices, when they are being developed, you’re doing it with intent in mind. Either it’s a completely novel, new idea or you saw a product and you said there’s a greater market than a particular other manufacturer offers, we want to jump into it or we want to improve it.”
“Let’s try to keep out anything of potential concern that we can at any concentration.”
Links:
FDA - Overview of Device Regulation
FDA - Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin
ISO 10993-1:2018 - Biological evaluation of medical devices
European Union Medical Device Regulation (EU MDR)
Medical Design and Manufacturing Event (MD&M West)