-
- News
- Books
Featured Books
- pcb007 Magazine
Latest Issues
Current IssueThe Growing Industry
In this issue of PCB007 Magazine, we talk with leading economic experts, advocacy specialists in Washington, D.C., and PCB company leadership to get a well-rounded picture of what’s happening in the industry today. Don’t miss it.
The Sustainability Issue
Sustainability is one of the most widely used terms in business today, especially for electronics and manufacturing but what does it mean to you? We explore the environmental, business, and economic impacts.
The Fabricator’s Guide to IPC APEX EXPO
This issue previews many of the important events taking place at this year's show and highlights some changes and opportunities. So, buckle up. We are counting down to IPC APEX EXPO 2024.
- Articles
- Columns
Search Console
- Links
- Events
||| MENU - pcb007 Magazine
FDA Approvals: Clearing the Hurdles
February 8, 2019 | Nolan Johnson, I-Connect007Estimated reading time: 3 minutes
Manufacturers of medical electronics have their work cut out for them. These products have to pass approval by the Food and Drug Administration (FDA) in addition to getting the nod from more typical entities such as Underwriters Laboratories (UL) and Conformité Européenne (CE, also known as European Conformity). Most medical device developers will admit that achieving FDA approval can be a big hurdle on the way to new product introduction (NPI).
The need to gain FDA approval may seem daunting. Approvals differ depending on so many different variables: classification, new technology or incremental improvement on existing products, and so much more. Michael Lynch, quality manager at Libra Industries in Mentor, Ohio, offered a brief explanation of FDA device classifications.
“Everything is risk-based. The FDA uses three main regulatory classes to group medical devices: Class I, Class II, and Class III. Class I devices require the lowest level of regulatory control because they present the lowest level of risk in the form of a low probability of causing injury if they don’t work properly. Class I devices are not used to sustain life,” said Lynch.
“Class II devices require a higher level of assurance that they will perform without causing harm to the patient than Class I,” he continued. “If a Class II device fails, there is a low risk of causing serious injury to the patient. Blood pressure monitoring equipment is a typical example of a Class II device. Though, because patients and staff may be depending upon these devices for feedback, Class II devices are designed and constructed to a high level of assurance that the device will work properly. Class III includes critical care and life support. A malfunction in a Class III device can cause serious injury or death.”
Based on the class of the product different pathways, objective evidence and requirements may be necessary. For example, one often-mentioned FDA clearance is Section 510(k) of the Food, Drug, and Cosmetic Act. According to the FDA code of federal regulation, Section 510(k) “requires device manufacturers… to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as premarket notification—also called PMN, or simply 510(k). The premarket notification allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories.” The 510(k) process could be considered one of the more well-known approval processes for medical products.
But there are other paths that a design team could follow to complete FDA approval successfully, all of which are worth exploring. We’ll look at examples from two new companies: 2C Tech and Project Vive.
Project Vive is a Pennsylvania-based bootstrapped startup creating the VozBox, an affordable, portable, durable communication device for people who have lost the ability to speak. 2C Tech’s (Irvine, California) product —although not strictly electronic—delivers an electrical stimulus to the patient’s retina. Both products enhance a patient’s sensory control in various ways and take different paths through the FDA approval process.
Strict R&D at 2C Tech
2C Tech has been developing a quantum dot (QD) technology that helps patients with degenerative retinal disease to see. The quantum dots are semiconductor crystalline structures a few nanometers in size. These quantum dots are injected into the retina where they absorb light and create an electric signal that the retina will recognize as a single wavelength. In essence, the patient achieves increased clarity in their monochromatic vision.
Jim Taylor, 2C Tech CEO, observed, “Most medical devices progress by ‘evolutionary steps’ rather than whole new concepts. If the innovators decided they had a way to make a better implantable defibrillator, for example, then a lot of the groundwork and pathway have already been pioneered; the task then is to innovate while leveraging that prior experience.” The 2C Tech technology may be extremely passive in its function, but it is injected into the patient’s tissues, making FDA classification of the technology trickier. Classification can have a dramatic impact on the development cycle for a medical product.
To read the full version of this article which originally appeared in the November 2018 issue of PCB007 Magazine, click here.
Suggested Items
IDTechEx Examines the Opportunities for Wearables in Digital Health
04/19/2024 | IDTechExIDTechEx’s report, “Digital Health and Artificial Intelligence 2024-2034: Trends, Opportunities, and Outlook”, covers this ongoing trend in the consumer health wearables market and includes analysis of the opportunities and roadmap for biometric monitoring.
INSPECTIS Offers Slider Plate Stand for Optical Inspection
04/01/2024 | INSPECTISINSPECTIS introduces a new specialized slider stand capability for repetitive optical inspection tasks, for example, for the production of special devices such as stents.
Absolute EMS Completes ISO 13485:2016 Recertification, Strengthening Commitment to Medical Device Quality Systems
03/25/2024 | Absolute EMS, Inc.Absolute EMS, Inc., an award-winning EMS provider of turnkey contract manufacturing services, proudly announces the successful completion of its ISO 13485:2016 audit, reaffirming its commitment to excellence in medical device manufacturing.
IMI Signs Memorandum with RRR Manufacturing PTY Ltd.
03/12/2024 | IMIIntegrated Micro-Electronics, Inc. (IMI), A memorandum of understanding (MOU) was recently signed between Integrated Micro Electronics Inc. and RRR Manufacturing PTY Ltd for the manufacture of portable automated external defibrillator solutions branded as CellAED. IMI will manufacture the full box build for the medical device that will be distributed both locally and abroad.
NEOTech Implements Advanced Technology for Enhanced Barcode Tracking in High-Tech Medical Device Production
03/08/2024 | NEOTechNEOTech, a leading provider of electronic manufacturing services (EMS), design engineering, and supply chain solutions in the high-tech industrial, medical device, and aerospace/defense markets, is thrilled to announce the implementation of improved technology to further enhance barcode tracking in the production of high-tech medical devices.