Fasten your medical device’s way to US market by ensuring you’re familiar with FDA rules and regulations

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The design and manufacturing of medical devices is way more challenging than engineering work and factory production of e.g. consumer electronics. In medical device business, it is not enough to have just a good end-product - the development and production processes also have to fulfill certain criteria. The companies must also be able to verify that they operate according to them. The authorities must exercise constant vigilance so that the safety and effectiveness of the device are ensured and verified before companies launch their devices to the market.


The “criteria” includes, e.g., the quality management system (QMS), which is a “must have” for every medical device designer and manufacturer. It covers processes related to the medical device’s development, manufacturing and maintenance throughout its whole life cycle. In addition to QMS, the regulatory requirements concerning medical devices are compelling. The operation of medical device designers and manufacturers is regulated, e.g., by region and country-specific laws and legislation. For example, EU’s medical device directive describes how a designer and manufacturer of medical devices has to operate.


In USA, there are own country-specific laws and legislation, as well. FDA's Centre for Devices and Radiological Health (CDRH) is responsible for regulating companies who manufacture, repackage, relabel, and/or import medical devices sold in the US. These regulations apply to specification developers, contract manufacturers and importers. The aim of the FDA regulations is to protect patients and users and to ensure safety and effectiveness of the devices. FDA regulations are a must for companies heading the US market.


Do you have an idea of a medical device? Or have you already started to develop your medical device? Do you want to enter the US market? If you answered yes, FDA rules and regulations is one very important matter you should be aware of. To fasten your product’s way to US market, you should ensure that your team is familiar with FDA regulations, which are a must for companies heading the US market. Follow this blog post to read our tips for medical device companies for US market entry!


Tip #1. Update your QMS to be compliant with FDA 21 CFR Part 820 (QSR)


One very important foundation is that all players in the medical device industry should have a quality management system compliant with FDA 21 CFR Part 820 (QSR) in place. The requirements set in the QSR are similar requirements that ISO 13485 standard has, but they are not identical. Therefore, manufacturers selling to Europe and heading to US markets must update their quality management system according to FDA requirements.


FDA does not require a pre-registration audit, but you’re required to be in compliance with applicable sections of the QSR before placing your device on the market. After that, the FDA conducts pre-announced and random, unannounced inspections to ensure your compliance. This includes inspections at contract manufacturer when the manufacturing has been outsourced.



Tip #2. To get your device classified and regulated by FDA, get yourself familiarized with a risk-based approach that is used


The approvals granted by the FDA is a necessary prerequisite to achieving the market authorization for the device. FDA uses risk-based approach when classifying and regulating medical devices.


The device classification regulation defines the regulatory requirements for a general device type. The devices are classified into three classes: Class I, Class II and Class III, and the type of pre-marketing application required for FDA clearance is mainly related to the class in which your device is assigned. Device classification depends on the intended use of the device and also upon indications for use.


The amount of regulatory controls naturally increases from Class I to Class III devices. The regulatory controls are divided in three categories; General controls, Special Controls and Premarket Approval (PMA).


General controls mean regulatory requirements authorized by the FD&C Act, under sections 501, 502, 510, 516, 518, 519, and 520. General controls apply to all medical devices, unless exempted by regulations. With Class I devices, the least regulatory control is applied.


Special controls are usually device-specific for Class II devices. This include, e.g., performance standards, post-market surveillance, patient registries, special labeling requirements, pre-market data requirements and other guidelines.


The devices with the highest risk – Class III – require FDA approval of premarket approval application (PMA) before marketing. To be able to receive approval from FDA for Class III devices, the manufacturer must demonstrate with sufficient, valid scientific evidence that there is a reasonable assurance that the devices are safe and effective for their intended uses.


Tip #3. Remember to follow the device labeling requirements set by FDA


There are several regulations related to medical devices labeling set by FDA. It should be noted that the labeling regulations include instructions for use as well as advertising material. Unique Device Identification is regulated in 21CFR Part 830 and is mandatory in US.


There are also requirements for manufacturing facilities related to labeling. The QA program must be adequate to ensure that labeling meets the GMP device master record requirements with respect to legibility and adhesion, and to ensure that labeling operations are controlled so that correct labeling is always issued and used.


Tip #4. Follow the FDA regulations throughout the whole lifecycle of your medical device


The companies should get themselves familiarized with the classifications, regulations and rules of FDA already at the idea phase of the device life cycle, if the aim is to enter the US market. This is because FDA regulations apply both to design and development as well as to manufacturing of the device.


It is crucial is that you have a design team that is familiar with FDA requirements. To fasten your product’s way to US market, you should ensure that your design team, whether in-house or a partner, knows about Design Control requirements FDA has set in FDA 21 CFR Part 820 as well as in other regulations and recognized standards. Design team should be aware of different guidance FDA has given related to device design and development, as well.


There are a number of guidelines written by FDA, that can help designers to prepare documentation that is as such useful when compiling application papers for example for FDA 510(k) submission. To avoid extra costs, double work and unnecessary documentation, choose a team that has robust processes for design control and experience of technical matters as well as regulatory requirements.


If you need a contract manufacturer, be sure that you have a partner that is compliant with FDA QSR and who has registered their establishments in the FDA register. Preferably, your contract manufacturer has a long experience of the FDA compliant QMS over the years and is familiar with the inspection protocols of the FDA. This ensures that the manufacturer has good manufacturing controls such as internal audits, management reviews, production and process controls and CAPA procedures etc. in place. Preferably, your contract manufacturer has also a MDSAP certificate. The Medical Device Single Audit Program allows an MDSAP recognized Auditing Organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities from US, Canada, Australia and Japan. US FDA accepts MDSAP audit reports as a substitute for routine Agency inspections. 


The basic regulatory requirements, that manufacturers of medical devices distributed in the U.S. must comply with, are; Establishment Registration and Medical Device Listing - 21CFR Part 807, Premarket Notification 510(k) - 21 CFR Part 807 Subpart E, Premarket Approval (PMA) - 21 CFR Part 814, Investigational Device Exemption (IDE) - 21CFR Part 812, Quality System Regulation (QS regulation) - 21 CFR Part 820, Labelling - 21 CFR Part 801 and Medical Device Reporting - 21 CFR Part 803.


But what you should also remember is that FDA rules and regulations are not the only thing you need to implement and follow. For example, there are many FDA recognized standards, lots of device specific guidance documents etc. that must be taken into account as well.  To read more about the regulatory process of the whole life cycle of the device, you can download our free White Paper including insights related to that. It shows an illustrated outline of the stages in developing your idea into a worldwide selling product in the medtech/healthtech sector. These phases demonstrate how to ensure compliance to enable medical devices to be placed on the market as smoothly as possible. Please download your free white paper below!


how to ensure the quality compliance of your medical product



Do you want to discuss about the subject with our professionals? Do not hesitate to contact us!


Innokas Medical has over 25 years of knowhow in practical application of quality and regulatory affairs, including FDA, in medical device development and manufacturing. We co-create with our clients the next generation medical devices, and our service offering covers the entire path of bringing new medical devices to the market. Our Design Studio team implement development projects according to ISO 13485 QMS and FDA QSR by following both EU harmonized and FDA recognized standards. On the other hand, our manufacturing process has ISO 13485:2016 and Canada ISO 13485:2003 certifications and it also complies with FDA regulations. All our three sites are FDA registered and FDA inspected.


We have a wealth of experience from participating in many different and demanding design projects, different manufacturing cases and we have successfully gone through several FDA inspections, unannounced audits and other regulatory audits. It really is a point of honour to us that we ensure that all the processes at Innokas follow all the required directives and regulations all the time. It is an easy choice for our clients to co-create with Innokas. Together, we can improve people’s lives by crafting healthtech ideas to safe and effective medical devices.


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