November 9, 2022

Advantages of an FDA-Regulated Medical Device Manufacturer

Working With an FDA-Regulated Medical Device Manufacturer

For OEM medical device product makers, having an FDA-regulated approach is essential. When using contract manufacturers, it's important to have business partners who understand the FDA approval process and are actively involved in complying with FDA requirements. Medical device manufacturing involves specific FDA directives and oversight intended to keep patients and processes safe.

Medical Device Manufacturing and Device Classification

Medical device manufacturers that work with the FDA routinely understand the various basic classifications of medical devices, including Class I, Class II, and Class III devices [1].
Class I devices are generally less technical products for clinical support, such as bandages, bedpans and latex gloves. These typically don’t need extensive regulatory review. They are seen as "basics" in hospital administration, partly because they are exempt from the process for most Class II and Class III items.
Class II products have some technology and some amount of complexity and may be subject to premarket/de novo processes. 
Class III products are the most technical items, such as defibrillators. They have the most FDA regulation and may require additional product development work related to FDA oversight. 
Along with the above classifications, FDA-regulated medical device manufacturers understand the FDA QSR standard and accompanying standards like ISO 13485 that govern the manufacturing of Class I, Class II, and Class III devices. In preserving the processes that help OEM device makers succeed, the manufacturers have to pay attention to these rules.

Medical Device Reporting Requirements

A legitimately FDA-regulated medical device manufacturer also understands MDR requirements in the industry. Throughout the entire life cycle of product development, it's important to consider the agency's rules [2]. Having a detailed idea of how the FDA addresses risk is an important part of the development of clinical products. The FDA calls medical device reporting one of its “postmarket surveillance” tools, and requirements are in place for the many thousands of products put through the regulatory process annually. Stakeholders can review FDA communications for adverse events, including: 
  • Use errors
  • Product quality issues
  • Therapeutic failures
  • Product-related injuries
This type of research goes a long way toward improving patient safety and ensuring a high standard of care in American hospitals. Each of these categories should be part of regular company review. 

Cost Estimation

FDA-regulated medical device manufacturers also have an easier time forecasting costs for products.
Some of this might have to do with product complexity — for example, what kind of support documentation is involved. These companies might also know about any exemptions that apply according to FDA rules and regulations for a given device. For example, the FDA may find that certain Class I and Class II devices are “not required to provide reasonable assurance of safety and effectiveness for the device,” which will impact manufacturing processes for those devices [3]
Factoring in all the answers to the question marks, companies get a better picture of what they will pay on their way through the FDA regulatory process. 

Bringing Products to Market

Another thing that medical device makers can rely on with FDA-regulated medical device manufacturers is a good working knowledge of how to bring projects to market.
In this process, premarket notification is a big step. Specifically, in complying with premarket notification and premarket approval processes for higher classes of devices, producers are submitting certain clinical information and analysis to the agency. With that in mind, the device specifications, and the context around its use, should be transparent. 
Knowing about these types of things helps companies ensure they are proceeding according to FDA rules. Details like labeling requirements and review protocols make a big difference in how devices are rolled out for clinical use.
For premarket notification exemptions, companies still have to consider CFR Title 21 Part 820 and Current Good Manufacturing Practice (CGMP) regulations. These standards address aspects like the production facilities and how they are set up, as well as manufacturing methods. Again, here, the manufacturer that is regulated by the FDA will understand the whole context: They will know, for example, how CFR Title 21 Part 820 and the QSR work together and how to satisfy applicable requirements in these situations.  

Building a Regulatory Strategy

Then there's the overarching process of evaluating FDA activity in the context of medical device manufacturing. Companies will want to spend time and invest in figuring out how to comply with FDA rules in a comprehensive way.
That might mean looking at warning letters and reviewing them for their projected impact on parts of the industry. It might mean reviewing guidance documents to chart a course for manufacturing.
Companies should be ready to dialogue with the agency in an appropriate way. Again, the active regulatory experience makes a difference!
Companies may also have to look at the testing requirements for various products. For example, knowing about the FDA’s voluntary Accreditation Scheme for Conformity Assessment (ASCA) Pilot program and laboratory requirements helps position the company well for FDA compliance. All of this makes active FDA regulation a valuable experience for those who are working with OEM medical device manufacturers.

If you’re looking for a medical device contract manufacturer that is experienced in electromechanical and electrical production, Sanbor Medical can help. Contact a member of their team.



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