How to get FDA approval?

The Food and Drug Administration (FDA) is the United States body responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices. When targeting the US market, the first hurdle to consider is the lengthy and arduous process of medical device registration with the FDA.
A medical device company will choose the appropriate regulatory pathway depending on the risk class of the device. In some cases a device may be exempt from registration with the FDA.

The three classes and their respective requirements are as follows:

Class IWith ExemptionsGeneral Controls
* Exemptions 21 CFR xxx.9

Without ExemptionsGeneral and Special510(k)
Class IIWith ExemptionsGeneral Controls and Special Controls* Exemptions 21 CFR xxx.9
Without ExemptionsGeneral Controls and Special Controls510(k)
Class IIIGeneral and premarket approval (PMA)PMA (postamendment** device)
510(k) (preamendments** device)
UnclassifiedDe novo
FDA Classes | Gemarmed

* xxx refers to Parts 862-892.
** Pre/post-amendment device = devices marketed before/after May 1976, when the Medical Device Amendments came into effect.

Application paths

The 510(k) process applies to all non-exempt medical devices which do not require Premarket Approval (PMA). This is the most common approval pathway for medical devices. It is used to demonstrate that a device is as safe, effective, and substantially equivalent to a predicate device that is already legally marketed in the US.
A medical device is considered substantially equivalent to a predicate device if they:
• have the same intended use; and
• have the same technological characteristics;
• have the same intended use; and
• have different technological characteristics and the device does not raise different questions of safety and effectiveness; and
• the information submitted to FDA demonstrates that the device is as safe and effective as the legally marketed predicate device.

510 (k)

If you think that your medical device is similar to others already in the marketplace, GEMAR can help. After confirming that the product is either a Class II medical device or a Class I device that is not exempt from the premarket notification requirements, we can assist you in the filing of a 510(k) submission with the FDA.

 A 510(k) is a premarket notification made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is ‘substantially equivalent’ (SE), to a legally marketed device. We can help you to collect and prepare the supporting documentation which compares your device to one or more similar legally marketed devices and then make and support your substantial equivalency claims.

GEMARMED can also assist in the determination of whether or not a new 510(k) is needed for a modification to an existing Class II device that is already on the market, and which type of 510(k) submission is best suited to your device: traditional, special or abbreviated. 

If there is no legally marketed similar device available on the US market, it may be possible to utilise the ‘de novo’ 510(k) route, as long as your device is ‘low’ or ‘medium’ risk.


Premarket approval (PMA) is the FDA process for evaluating the safety and effectiveness of Class III medical devices. Class III medical devices are considered to be the highest risk devices and are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.

A company must receive FDA approval of its PMA application prior to marketing the device. This approval is based on a determination that the PMA contains sufficient valid scientific information to assure that the device is safe and effective for its intended use(s).

GEMARMED is qualified to assist you in every step of the PMA process including: 

  • Assisting you in compiling the necessary information for the submission
  • Participating in telecons and face-to-face discussion meetings with the FDA
  • Submitting the PMA application to the FDA
  • Responding to questions from the FDA
  • Preparing for an advisory committee meeting
  • Arranging ‘pre-sub’ calls, submissions and meetings with FDA to discuss upcoming submissions

De Novo

What is a De Novo Classification Request?

The De Novo process provides a pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device. De Novo classification is a risk-based classification process.

Devices that are classified into class I or class II through a De Novo classification request (De Novo request) may be marketed and used as predicates for future premarket notification [510(k)] submissions.

How to Prepare a De Novo Request

There are two options for when a requester can submit a De Novo request for the FDA to make a risk-based evaluation for classification of the device into class I or II.

  • Option 1: After receiving a high-level not substantially equivalent (NSE) determination (that is, no predicate, new intended use or different technological characteristics that raise different questions of safety and effectiveness) in response to a 510(k) submission.
  • Option 2: Upon the requester’s determination that there is no legally marketed device upon which to base a determination of substantial equivalence (therefore without first submitting a 510(k) and receiving a high-level NSE determination).


Medical device firms that manufacture medical devices imported into the United States (US), including contract manufacturers and contract sterilizers, must designate a US Agent. After designating the US Agent, the device firm must notify the US Food and Drug Administration (FDA) of the name, address and phone number of their US Agent during the annual on-line registration process. In accordance with the regulations in 21 Code of Federal Regulations (CFR) 807.40, each non-US establishment may designate only one US Agent, who is either a resident of the United States or maintains a place of business in the US.

GEMARMED thought US partners can provide the US Agent services, qualified to represent your company’s regulatory interests in an appropriate manner. GEMARMED US Agent meets this requirement, having the following expertise: 

  • We have more than 25 years of experience in communicating with the FDA.
  • We understand the challenges for foreign companies, due to our expertise on different country regulations and extensive experience in assisting non-US device manufacturers.
  • If needed, we can provide clarifications on FDA inquiries and assist your firm in providing effective responses to FDA questions on your products.
  • We can help you to prepare for FDA inspections.


As your US Agent, GEMARMED will be responsible for: 

  • Assisting FDA in communications with your company
  • Responding to questions concerning your products that are exported or offered for export to the US, and
  • Assisting FDA in scheduling inspections of your company

 GEMARMED is also ready to assist you with registration and listing, and can answer any questions that you may have.

 Please note that FDA does not require the U.S. Agent to report adverse events under the Medical Device Reporting regulation (21 CFR Par 803) or submit 510(k) Premarket Notifications on behalf of your firm.

How can we help?

When marketing a medical device, speed to market represents a crucial competitive advantage. GEMARMED’s experts are highly experienced in navigating the ever-changing regulatory maze and will guide you through the FDA device clearance process to accelerate processes, promote your company’s success, and lead to profitability.

GEMARMED can also assist in the determination of whether or not a new 510(k) is needed for a modification to an existing Class II device that is already on the market, and which type of 510(k) submission is best suited to your device: traditional, special or abbreviated. 

With the help of GEMARMED’s experts, you will be able to easily classify of your device, resolve compliance issues, identify legally marketed similar device available on the US market, provide a regulatory perspective for managerial decisions, and submit all necessary forms, requests, and obligatory fees. By doing so, you will save precious time and money thereby expediting your success

Medical Device Reporting (MDR)

The Medical Device Reporting (MDR) Regulation (21 CFR 803) requires that all manufacturers report to FDA whenever a device: 

  • may have caused or contributed to a death or serious injury or
  • has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur

 GEMARMED is prepared to assist you in deciding what is required to be reported and how soon it is required to be reported, as well as what form the information should be submitted on. We can also assist you in developing, maintaining, and implementing written MDR procedures for your company – contact us for further information.

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