Gaining Regulatory Approval

To market a medical device in the US, the manufacturer of record (you, the company selling the device) needs to obtain approval or clearance from the U.S. Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) for your device.  This in turn requires evidence that the device was designed under a quality system conforming to US Code of Federal Regulations 21 CFR part 820 (and in particular Design Controls) and manufactured under a quality system conforming to 21 CFR part 820. This is the law, no option here.  A design partner’s ISO-13485 certification demonstrates that their QMS (quality management system) complies and the FDA considers ISO-13485 an acceptable implementation of the law.  Using a design firm that has a current ISO-13485 certificate covering Design Controls will greatly improve your chances of submitting a complete package to the FDA and international regulatory bodies.  Also be sure that the contract manufacturer (CM) you choose has a current ISO-13485 certificate covering Medical Device Manufacturing; non-compliant manufacturing leads to recalls, potential safety issues and potential brand damage.

In reviewing medical devices, the FDA cares primarily about two things: Safety and Efficacy.



Compliance with medical device standards such as IEC-60601-1 for medical electronics and IEC-62304 for medical software is the easiest way to demonstrate to the FDA that your development process included risk management considerations and meets generally acceptable safety standards. The FDA requires a design history file (DHF) containing evidence that a compliant quality system was followed to get cleared or approved.  The use of a Nationally Recognized Test Laboratory (an NRTL; e.g. UL, TUV or Intertek) is required to verify conformance to the appropriate consensus-based product safety test standards (eg. IEC 60601-1).

Risk management (process defined in ISO 14971) is a cornerstone for identifying and addressing safety concerns (hazards) associated within medical devices.  Designing medical devices is not just about whether the end design works safely; it’s also about following a compliant process along the way and documenting the process steps as evidence to conformance.



The FDA will require the device “manufacturer of record” (you, the organization selling the device) to demonstrate that your device meets the claims you publish for the device (in the device ‘labeling’). More ambitious claims, generally require more extensive clinical or simulated use testing. For example, it is much easier for a manufacturer to claim their device measures body temperature at a certain location within + or - x degrees than it is to claim the that their device detects infection.

Consulting with regulatory strategists is highly recommended to help form your claim vs. testing vs. market-needs and to design your clinical or simulated use study to demonstrate efficacy.

FDA Submissions

The type of medical device determines the type of FDA submittal required.  A 510(k) Clearance is required for most Class II devices (e.g. monitors, most diagnostic and less invasive therapeutic devices)  that have a predicate or share the features of multiple different predicate devices.  The more rigorous and time consuming Pre-market Approval (PMA) is required for Class III devices (e.g. life supporting or implantable devices) and for those devices that are new and have no predicate to compare to.  There are other options (e.g the de Novo 510(k)) that can be investigated by your regulatory resources.

The FDA allows medical device developers to meet with the FDA in a “pre-IDE” meeting to review proposed device classifications and clinical plans.  This is highly recommended to prevent surprises during the FDA review process and possibly having to repeat clinical studies.

In all cases, a strong Design History File (DHF); along with your labeling and clinical validation documentation,  form the foundation for your application.   Your design team will compile the DHF to demonstrate that the proper processes were followed.

To read more at the FDA website click here...


Medical Devices Directive  and the ‘CE’ Mark

If you plan to market a medical device in Europe, you need to demonstrate that your medical device meets the requirements in the Medical Device Directive (MDD) by performing a conformity assessment. This assessment varies according to the classification of the device.  CE Marking is a manufacturer's declaration that the product complies with the ‘essential requirements’ of the relevant European health, safety and environmental protection legislation (EU Directives).

CE marking indicates to EU regulators that your device meets all applicable requirements of the appropriate EU Directive, such as the Medical Device Directive (MDD), In Vitro Diagnostic Device Directive (IVDD) or Active Implantable Medical Device Directive (AIMD), as they apply to your device.

In most cases where a medical device contains electronics, the internationally harmonized standard IEC 60601-1 forms the core of the safety requirements that must be met; same as for the FDA.

While non-medical products generally self-declare that they meet the EU directives; medical devices are generally required to use of an EU Notified Body (e.g. TUV) to assess compliance with the Directive before the CE mark can be applied to a device.

To read more about the Medical Devices Directive (MDD) click here...