PMA applications

Class III devices, unless they are substantially equivalent to a device already marketed without a PMA application, require formal FDA approval through the PMA process before initial sale. The PMA process is comparable to the new drug approval process (18). In both cases, safety and effectiveness data must be reviewed by FDA prior to marketing. An approved PMA application acts like a private license granted to the applicant to market a particular device. Other firms seeking to market the same type of device for the same use must also have an approved PMA. 

PMA requirements differ between preamendment and post-amendment devices. Preamendment devices are those in commercial distribution before May 28,1976 post-amendment devices are those first commercially distributed after the date. Class III post-amendment devices that are not substantially equivalent to preamendment Class III devices are considered new devices. Manufacturers of such devices are required to obtain PMA application approval before marketing these. If the post-amendment device is substantially equivalent to a preamendment device and FDA has not initiated a regulatory process specifically requiring the submission of a PMA for the device category, a 510(k) submission can be made. 

Summary and Bibliography of Reports of Scientific Investigations and Literature. You are required to provide a summary and bibliography of reports in the scientific literature that are known, or that reasonably should be known to you, and that were not previously submitted as part of your PMA application [21 CFR 814.84(b)(2)(ii)]. If there are reports or scientific literature on clinical or nonclinical studies of similar devices, we recommend that you include them in your summary and bibliography. 

The PMA is the most stringent of the FDA s device marketing applications and applies to Class-Ill devices. A PMA often involves a new concept or technology, with no predicate device on the market, and involves a high risk to the patient. The PMA application requires extensive documentation. Results from clinical (hiunan) trials must include study protocols, safety and efficacy data, adverse reactions and comphcations, device... 

Section 209(b) of the FDAMA states that the FDA must, upon written request of the applicant, meet with that party within 100 days of receipt of the filed PMA application to discuss the review status of the application. Prior to this meeting, the FDA must inform the applicant in writing of any identified deficiencies and what information is required to correct these deficiencies. The FDA must also promptly notify the applicant if the FDA identifies additional deficiencies or any additional information required to complete the agency s review. Sections 201 (a), 205(a), and 209(b) provide early collaboration and allow for frequent interaction between the applicant and the FDA to address deficiencies. 

Clinical data are required in all premarket approval applications. The PMA applicant must provide a cogent demonstration of the safety and effectiveness for all diagnostic and/or therapeutic medical claims for the device based on laboratory, animal, and clinical data. 

Premarket Approval (PMA) is the FDA process to evaluate the safety and effectiveness of all Class III devices. Due to the level of risk associated with Class III devices, the FDA has determined that general and special controls alone are insufficient to assure their safety and effectiveness. Therefore these devices require a premarket approval (PMA) application under section 515 of the act, in order to obtain marketing clearance. 

Guidance is available to assist manufacturers in preparing the quality system information required in the PMA application. This is particularly valuable for companies who elect a modular review. If the company elects to use this method, the FDA suggests that the design control information and manufacturing information be submitted in modules that are separate from other information. (See Quality System Information for Certain Premarket Application Reviews Guidance for Industry and FDA Staff, issued February 3, 2003.)... 

To facilitate the FDA s handling of PMA applications, the following recommendations are offered ... 

Clearly and prominently identify the submission as an original PMA application or, for additional submissions to a PMA application, clearly identify the FDA assigned document number (e.g., P030000) and type of submission (amendment, supplement, or report), and the type of submission (e.g., Response to an FDA letter dated ). 

Only the PMA applicant on record with the FDA may amend, supplement, or submit reports to their PMA, unless the PMA includes the original and not a copy of an appropriate letter of authorization from the applicant permitting another person to submit information on behalf of the applicant. 

ENVIRONMENTAL ASSESSMENT (21 CFR 25.31). If an applicant believes that the device qualifies for an exemption, they must provide information that establishes to the FDA s satisfaction that the device meets the criteria for a categorical exclusion (21 CFR 25.24). The majority of PMA applications have been granted categorical exclusion. The submission of an environmental assessment in a separate volume will expedite FDA review. Three copies are needed. 

Once the manufacturer files the PMA application, the FDA must make a threshold determination about whether the application is sufficiently complete for the agency to undertake a substantive review. The PMA regulation [21 CFR 814.42(e)] states that the FDA may refuse to file a PMA if any of the following applies ... 

Before submitting a PMA, applicants are encouraged to interact with CDRH review staff. Such presubmission interaction is an important way of improving the quality and completeness of a PMA and thus increases the likelihood of fileability. Applicants are... 

As summarized by the FDA, an investigational device exemption (IDE) allows a device to be used in a clinical study to collect safety and effectiveness data required to support a PMA application or a Premarket Notification [510(k)j submission to FDA. All clinical evaluations of investigational devices must have an approved IDE before a clinical study can be initiated. An approved IDE permits a device to be shipped lawfully for the purpose of conducting investigations of the device without complying with other requirements of the Eood, Drug, and Cosmetic Act that would apply to devices in commercial distribution (FDA, 2009). 

The purpose of this document is to list the data needed for orthopedic devices containing UHMWPE. These data should be included in premarket notifications (510k), Investigational Device Exemptions (IDE) applications. Premarket Approval (PMA) applications, reclassification petitions, and master files to aid FDA in determining the substantial equivalence and/or safety and effectiveness of UHMWPE in implantable orthopedic devices. In this document UHMWPE is referred to as polyethylene (PE). 

The FDA has a statutory 180-day review cycle for PMA applications. Often PMA applications require medical advisory board review prior to the FDA granting approval to market the device. A facility inspection verifying the systems for the mannfacture of the medical device is usually performed prior to PMA approval. FDA approval of a PMA often takes significantly more than 180 days. 

Guidance for Industry and Food and Drug Administration Staff (2012) The content of investigational device exemption (IDE) and premarket approval (PMA)—applications for... 

---