Premarket Submissions: Selecting and Preparing the Correct Submission

How to Study and Market Your Device outlines four steps for bringing a medical device to market in the United States. This section is designed to assist you with: 

• Step Two: Select and Prepare the Correct Premarket Submission
• Step Three: Send Your Premarket Submission to the FDA

TYPES OF PREMARKET SUBMISSIONS

Premarket Notification 510(k)

For Class I and II devices that are not exempt from premarket review or are not subject to another type of marketing submission.

510(k) Third Party Review Program

A voluntary alternative review process for certain low-to-moderate risk devices.

Premarket Approval (PMA)

For Class III devices.

De Novo Classification Request

For novel low-to-moderate risk medical devices with no predicate device.

Humanitarian Device Exemption (HDE)

For devices intended for diseases or conditions that affect small (rare) populations.

Investigational Device Exemption (IDE)

For investigational devices to be used in a clinical study to collect safety and effectiveness data.

SUPPORT FOR PREMARKET SUBMISSIONS

Standards and Conformity Assessment Program

A resource on FDA-recognized standards, which includes the Accreditation Scheme for Conformity Assessment (ASCA).

Biocompatibility Assessment Resources

A resource for manufacturers on the FDA’s assessment of the biocompatibility of devices, including color additives.

Device Master Files

CDRH Device Master Files (MAFs) are voluntary submissions of confidential information to the Agency.

PREPARING, SENDING, AND TRACKING SUBMISSIONS

eCopy Program for Medical Device Submissions

How to create and submit an electronic version (eCopy) of a device submission.

Voluntary eSTAR Program

How to use the electronic Submission Template And Resource (eSTAR) PDF template.

Send and Track Medical Device Premarket Submissions Online: CDRH Portal

How to send and track eSTAR and eCopy premarket submissions online.

USER FEES

Medical Device User Fees

How to prepare and submit payment of user fees for medical device submissions.

Reduced Medical Device User Fees for Small Businesses

How to submit a Small Business Certification Request.

Contact Us

U.S. Food and Drug Administration
Center for Devices and Radiological Health
Document Control Center (DCC) – WO66-G609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002

301-796-6250

For Latest Updates Follow

@FDADeviceInfo

Information and news on device recalls, other safety issues, approvals, and other device and radiation-emitting product topics.