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  5. Premarket Submissions: Selecting and Preparing the Correct Submission
  6. Premarket Approval (PMA)
  1. Premarket Submissions: Selecting and Preparing the Correct Submission

Premarket Approval (PMA)

Send Medical Device eSTAR and eCopy Premarket Submissions Online

October 3, 2022 - The FDA is announcing that you may now send electronic copy (eCopy) or electronic Submission Template And Resource (eSTAR) premarket submissions online through the CDRH Customer Collaboration Portal ("CDRH Portal").

Building on the progress tracker for 510(k) submissions launched in 2021 and the trial process of electronic uploads launched in July 2022, the CDRH Portal now allows anyone to register for a CDRH Portal account to send CDRH eCopy or eSTAR premarket submissions online.

Starting October 1, 2023, all 510(k) submissions, unless exempted*, must be submitted as electronic submissions using eSTAR.

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Please note: FDA charges a fee for review of Premarket Approval Applications (PMAs)

Overview

Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III devices 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. Due to the level of risk associated with Class III devices, FDA has determined that general and special controls alone are insufficient to assure the safety and effectiveness of Class III devices. Therefore, these devices require a premarket approval (PMA) application under section 515 of the FD&C Act in order to obtain marketing approval. Please note that some Class III preamendment devices may require a Class III 510(k). See the PMA Historical Background webpage for additional information.

PMA is the most stringent type of device marketing application required by FDA. The applicant must receive FDA approval of its PMA application prior to marketing the device. PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use(s).

The PMA applicant is usually the person who owns the rights, or otherwise has authorized access, to the data and other information to be submitted in support of FDA approval. This person may be an individual, partnership, corporation, association, scientific or academic establishment, government agency or organizational unit, or other legal entity. The applicant is often the inventor/developer and ultimately the manufacturer.

The regulation governing premarket approval is located in Title 21 Code of Federal Regulations (CFR) Part 814, Premarket Approval of Medical Devices. A Class III device that fails to meet PMA requirements is considered to be adulterated under section 501(f) of the FD&C Act and may not be marketed.

When a PMA is Required

PMA requirements apply to Class III devices, the most stringent regulatory category for medical devices. Device product classifications can be found by searching the Product Classification Database. The database search provides the name of the device, classification, and a link to the Code of Federal Regulations (CFR), if any. The CFR provides the device type name, identification of the device, and classification information.

A regulation number for Class III devices marketed prior to the 1976 Medical Device Amendments is provided in the CFR. The CFR for these Class III devices that require a PMA states that the device is Class III and will provide an effective date of the requirement for PMA. If the regulation in the CFR states that “No effective date has been established of the requirement for premarket approval,” a Class III 510(k) should be submitted.

Please note that PMA devices often involve new concepts and many are not of a type marketed prior to the Medical Device Amendments. Therefore, they do not have a classification regulation in the CFR. In this case, the product classification database will only cite the device type name and product code.

If it is unclear whether the unclassified device requires a PMA, use the three letter product code to search the Premarket Approval (PMA) database and the 510(k) Premarket Notification database. These databases can also be found by clicking on the hypertext links at the top of the product classification database web page. Enter only the three letter product code in the product code box. If there are 510(k)’s cleared by FDA and the new device is substantially equivalent to any of these cleared devices, then the applicant should submit a 510(k).

Furthermore, a new type of device may not be found in the product classification database. If the device is a high risk device (supports or sustains human life, is of substantial importance in preventing impairment of human health, or presents a potential, unreasonable risk of illness or injury) and has been found to be not substantially equivalent (NSE) to a Class I, II, or III [Class III requiring 510(k)] device, then the device must have an approved PMA before marketing in the U.S. Some devices that are found to be not substantially equivalent to a cleared Class I, II, or III (not requiring PMA) device, may be eligible for the De Novo process as a Class I or Class II device. For additional information on the De Novo process, see the De Novo section of Device Advice.

Devices Used in Blood Establishments

The Center for Biologics, Evaluation, and Research (CBER) has expertise in blood, blood products, and cellular therapies as well as the integral association of certain medical devices with these biological products. To utilize this expertise marketing and investigational device submissions (Premarket Notification, Premarket Approval, and Investigational Device Exemption) for medical devices associated with the blood collection and processing procedures as well as those associated with cellular therapies are reviewed by CBER. Although these products are reviewed by CBER, the medical device laws and regulations still apply.

In addition to CDRH guidance on Premarket Approval, please contact CBER for specific medical device guidance for devices reviewed by CBER at either 1-800-835-4709 or Industry.Biologics@fda.hhs.gov

Data Requirements

A Premarket Approval (PMA) application is a scientific, regulatory documentation to FDA to demonstrate the safety and effectiveness of the Class III device. There are administrative elements of a PMA application, but good science and scientific writing is a key to the approval of PMA application. If a PMA application lacks elements listed in the administrative checklist, FDA will refuse to file a PMA application and will not proceed with the in-depth review of scientific and clinical data. If a PMA application lacks valid clinical information and scientific analysis on sound scientific reasoning, it could impact FDA's review and approval. PMA applications that are incomplete, inaccurate, inconsistent, omit critical information, and poorly organized have resulted in delays in approval or denial of those applications. Manufacturers should perform a quality control audit of a PMA application before sending it to FDA to assure that it is scientifically sound and presented in a well-organized format.

Technical Sections: The technical sections containing data and information should allow FDA to determine whether to approve or disapprove the application. These sections are usually divided into non-clinical laboratory studies and clinical investigations.

Non-clinical Laboratory Studies Section: Non-clinical laboratory studies section includes information on microbiology, toxicology, immunology, biocompatibility, stress, wear, shelf life, and other laboratory or animal tests. Non-clinical studies for safety evaluation must be conducted in compliance with 21 CFR Part 58 (Good Laboratory Practice for Nonclinical Laboratory Studies). To assist you in determining the appropriate non-clinical bench studies for your device, refer to the applicable guidance documents and standards identified in the Product Classification database for your device type. You may also seek input from the review division through a Pre-Submission.

Clinical Investigations Section: Clinical investigations section includes study protocols, safety and effectiveness data, adverse reactions and complications, device failures and replacements, patient information, patient complaints, tabulations of data from all individual subjects, results of statistical analyses, and any other information from the clinical investigations. Any investigation conducted under an Investigational Device Exemption (IDE) must be identified as such.

Like other scientific reports, the FDA has observed problems with study designs, study conduct, data analyses, presentations, and conclusions. Investigators should always consult all applicable FDA guidance documents, industry standards, and recommended practices. Numerous device-specific FDA guidance documents that describe data requirements are available. Study protocols should include all applicable elements described in the device-specific guidance documents.

References

List of references for Premarket Approvals

Other Resources



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