Understanding FDA Approval & Regulations for Medical Devices

The medical device manufacturing industry is quite a lucrative sector. However, it is one of the heavily regulated sectors of the global landscape. The reason for this is simple: these devices impact human health and well-being. If not regulated properly, then the safety, reliability, and effectiveness of these devices can be jeopardized.

Prior to being marketed or sold in the US, a medical device manufactured by a company must receive FDA approval for sale. In order to guarantee the end user’s safety and effectiveness when using medical devices that are sold in the US, the FDA creates restrictions. Though they can also help medical device manufacturers, these restrictions are an important part of patient and consumer safety. For instance, the FDA’s quality system requirements (QSR) assist manufacturers in making sure that the device they have created will be appealing to consumers and, as a result, successful in the marketplace.

There are three classes for medical devices: I, II, and III. Class III regulations are more stringent than Class I regulations. The regulatory specifications for a generic device type are specified in the device categorization regulation. Premarket Notification 510(k) is not applicable to many Class I devices; it is required for the most of Class II devices, and it is required for the majority of Class III devices to receive premarket approval. “Classification of Medical Devices” provides information about device classification as well as a link to the Product Classification Database.

US FDA – The Basic Regulatory Requirements

There are five basic regulatory requirements of FDA that must be known by every medical device manufacturer (who wishes to market their devices in the US):

  1. Establishment Registration
  2. Medical Device Listing
  3. Premarket Notification (510(k))
  4. Premarket Approval (PMA)
  5. Investigational Device Exemption (IDE)

Lets explore each of these regulatory requirements one-by-one.

Establishment Registration (Title 21 CFR Part 807

It is mandatory for operators or owners of establishments producing and distributing medical devices in the US to register themselves with US FDA.

The entities required to fulfill this obligation can include:

  • Specification developers
  • Initial importers
  • Contract manufacturers, and
  • Re-packers/re-labelers, etc.

Steps Required for the Establishment Registration

There are four steps in the establishment registration process:

Step 1: The entity willing to register itself should create and login to the Facility User Fee Account made with the US FDA.

Step 2: It should verify (or update) the company details to generate a PIN (Personal Identification Number).

Step 3: Using the Device Facility User Fee website, pay the annual fee comprising $7653**.

Step 4: The registration and listing data will be entered with the US FDA’s Unified Registration and Listing System (FURLS) or the Device Registration and Listing Module (DRLM).

**The registration fee is relevant till October 2024 only.

Medical Device Listing  (Title 21 CFR Part 807)

Medical device manufacturers are required to provide a list of medical devices they are distributing in the US. This process helps track devices in the market and the specific activities being performed on them. All medical device listing is required to be done electronically unless the manufacturer is granted a waiver.

Premarket Notification (510(k) (Title 21 CFR Part 807)

The Premarket Notification (510(k)) regulatory pathway is a submission process using which medical device manufacturers can get clearance from the FDA to market their products in the US market. Under this pathway, a medical device manufacturer has to submit a premarket notification to the FDA. This Pre-market notification includes information about:

  • Intended use of the device
  • Design of the device, and
  • Its performance characteristics against a predicate device 

What is the Goal of 510(k) Submission?

The goal of 510(k) submission is to show that a medical device is “substantially equivalent” to a device which the FDA has already cleared for commercial distribution. This previously cleared device is also known as a predicate device.

After determining that the device is substantially equivalent to a predicate device, FDA issues a clearance letter which the manufacturer can use to market their device in the US.

Note: Issuing a clearance letter does not mean that the device has been approved by the FDA. Rather, it denotes that the FDA has considered the device to be equivalent of a similar device already present in the market.

Premarket Approval (PMA) (Title 21 CFR Part 814)

Premarket approval is the scientific process to evaluate safety of Class III medical devices. The FDA defines Class III medical devices as the ones that

“usually sustain or support life, are implanted or present a potential unreasonable risk of illness or injury.”

Class III medical devices are the most highly regulated of all three device classes.

If Premarket Approval Application (PMA) gets approved, then it behaves like a private license granted to the applicant who can use it to market the particular device. If a Class III device does not meet the PMA requirements, then it is considered adulterated under Section 501(f) and thus, cannot be marketed.

Investigational Device Exemption (IDE) (Title 21 CFR Part 812)

Investigational Device Exemption allows an investigational device to be used in a clinical study to collect data regarding its safety and effectiveness. Often, these studies are performed to support a Premarket Approval.

Investigational use also includes:

  • New intended uses of legally marketed devices, and
  • Clinical evaluation of certain modifications

It is important to know that before initiating the study, all clinical evaluations of investigational devices must have an approved IDE (unless exempted).

If a device has not been cleared for marketing, then its clinical evaluation will require the following:

  • Monitoring of the study
  • Required reports and records
  • Informed consent of all the patients
  • A labeling which says that device will only be used for investigational purposes, and
  • An investigational plan that has been approved by IRB (Institutional Review Board). In case the study involves a device with significant risk, then the IDE must also be approved by FDA.

Having an approved IDE allows the manufacturers to lawfully ship their device to conduct investigations on it. With IDE, there is no need to comply with other requirements of the FD&C (Food, Drug, and Cosmetic) Act. Moreover, there are certain perks for sponsors whose devices are under investigation, such as:

  1. The do not need to submit a Premarket Notification 510(K) or PMA during the investigation
  2. The do not need to register their establishment, and
  3. They do not need to list their device.

IDE sponsors are also exempted from the Quality System (QS) Regulation except for design control requirements (21 CFR 820.30).

Looking for consultation on the FDA regulatory process?

If you are a medical device manufacturer willing to manufacture and/or market your device in the USA, then our experts at TS Quality and Engineering can provide you with all the necessary help. With our consultation sessions, you will get all the essential knowledge regarding FDA registration hassle-free. We will also enable you to place you device in the market by complying with all the FDA requirements. Contact us at to book you consultation session today!

About the Author

Waqas Imam

S. M. Waqas Imam is associated with TS Quality as a Regional Partner. He is also an ambassador of Medical Device Community. He is an Industrial Engineer by qualification and served the manufacturing industry since 2011. He is also IRCA CQI Lead Auditor of ISO 9001 and other management system standards. He had served as Quality Assurance and Regulatory Affairs Manager in QSA Surgical Pvt. Ltd. and Ultimate Medical Products. He managed requirements of ISO 13485:2003, EU directives, CE marking and FDA. He also served as Expert Blog Writer for 13485Academy and wrote expert articles on various topics of ISO 13485:2016.