We have discussed the various aspects of choosing a contract manufacturer before, some of the past topics can be read here, here, and here. In this post, we are going to examine what it takes for an OEM (Original Equipment Manufacturer) and their partner CM (Contract Manufacturer) to get the seal of approval from the FDA, and get that finished device onto the market.
One of the big barriers of enabling the product to enter the market is having to meet government regulations. Any medical device must reach regulatory compliance under the FDA’s standards, and depending on the type of device and the complexity of its regulations, this process can turn out to be quite time and resource consuming.
On the OEM’s side, after they have chosen an efficient and trustworthy contract manufacturer like Sanbor Medical, they will need to have a DHF (Design History File), which is a compilation of their new device’s full record of design history. It is then submitted, along with other countless documents, to the FDA for approval. If everything meets the FDA’s requirements, Class I devices, if required, along with most Class II devices will obtain a 510k approval and Class III devices will obtain a Pre-Market Approval (PMA).
With protecting the consumers in mind, the FDA then reviews the device’s design for its safety and efficacy. The final product needs to fulfill all of its claims while remaining absolutely safe to use.
After obtaining the FDA’s approval, things move on into the hands of your trusted contract manufacturer. During Sanbor Medical’s production cycle of your device, we maintain records in strict accordance with the FDA’s regulation 21 CFR part 820, which mainly consists of two sets of records:
Device Master Record (DMR) includes: device specification, production process specifications, quality assurance procedures and specifications, packaging & labeling specifications and installation, maintenance and servicing procedures and methods.
Device History Record (DHR) includes: dates of manufacture, quantity manufactured, quantity released for distribution, acceptance records, primary identification label, and any unique device identifier (UDI).
On top of keeping impeccable records, as the manufacturer, Sanbor Medical must also validate all of the manufacturing methods and processes. Validation means confirmation by examination and provision of objective evidence, that the particular requirements for a specific intended use can be consistently fulfilled. Then comes process validation, which means establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.
Without any of the aforementioned records, a finished product will not be allowed on the market. These records are not collected at the end of the design or manufacturing cycles, but instead, need to be carefully and thoroughly documented as each step of the processes moves along. Record keeping should be one of the most essential parts of designing and making a medical device. Sanbor Medical always follows every requirement of the FDA’s 21 CFR part 820 regulations. When it comes to trusting your Class I & II devices and Class I, II and III subsystem assemblies to an experienced contract manufacturer that will adhere to all of the necessary government standards, Sanbor Medical will be an excellent choice for you.
Don’t forget Sanbor Medical is always here for your comments or questions, and we are eager to help you with your next exciting project. Simply contact us here or click on any of our contact links at your convenience!