To be able to enter the certain markets with a medical device, it is not enough to have just a good end-product - the development and production processes also have to fulfill certain criteria. 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 “must have” for every medical device manufacturer. In addition to QMS, the regulatory requirements concerning medical devices are compelling. The operation of medical device manufacturers is regulated, e.g., by region and country-specific laws and legislation.
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 United States. 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.
In USA, the QMS must be compliant with FDA 21 CFR Part 820 (QSR)
The foundation that all players in the medical device industry should have in place is a quality management system compliant with FDA 21 CFR Part 820 (QSR). The QSR is similar to the ISO 13485 standard for quality management systems, but not the same. 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 are required to be in compliance with applicable sections of the QSR before placing your device on the market. After placing device on the market, the FDA conducts pre-announced and random, unannounced inspections to ensure compliance. This includes inspections at contract manufacturer when the manufacturing has been outsourced.
A risk-based approach for regulating medical devices is used by FDA
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.
Devices are classified into three classes: Class I, Class II and Class III. The device classification regulation defines the regulatory requirements for a general device type. The type of pre-marketing application required for FDA clearance to market is related to the class to which your device is assigned. Device classification depends on the intended use of the device, and also upon indications for use.
Regulatory control increases from Class I to Class III. The regulatory controls are General controls, Special Controls and Premarket Approval (PMA).
General controls are 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. If a device is exempted from one of the general controls, such exemption is stated in the classification regulation for that device. 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.
Device labeling requirements set by FDA
There are several regulations related to medical devices labeling set by FDA, as well. 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.
FDA regulations apply both to development and to manufacturing of a 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 applies 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.
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 is not the only thing you need to implement and follow. All the other standards and requirements must be taken into account, too. To read more about the regulatory process of the whole life cycle of the device, you can download our 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!