Please note: As of October 1, 2002, FDA charges a fee for review of Premarket Approvals
- Who can submit a PMA?
- Are data from foreign clinical studies accepted by FDA?
- How does the sponsor notify FDA of a change in address of the official correspondent for a PMA under review?
- Is FDA approval required to change the trade name of the device?
- Can the sponsor sell the PMA to another company?/ How does the owner notify FDA of a change in ownership?
- Can the PMA holder enter into a licensing agreement with another manufacturer?
- Can the sponsor change the manufacturing site of the PMA approved device?
- Does an extension of product shelf life require a PMA supplement?
- How can I find more information about a PMA under review?
- Can I obtain a copy of a PMA submission?
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 of the PMA. This person may be an individual, partnership, corporation, association, scientific or academic establishment, government agency or organizational unit, or other legal entity. Often times the applicant is the inventor/developer and ultimately the manufacturer. If the applicant does not reside or have a place of business within the U.S., the PMA must be countersigned by an authorized representative who does. [§814.20]
A study conducted under an investigational device exemption (IDE) outside the United States and submitted in support of a PMA must comply with the IDE regulation (21 CFR 812). A study conducted outside the U.S. which was not conducted under an IDE must comply with one of the following:
- Research begun on or after effective date November 19, 1986: FDA will accept studies which have been conducted outside the U.S. and begun on or after November 19, 1986, if the data constitute valid scientific evidence (§860.7) and the investigator has conducted the studies in conformance with the "Declaration of Helsinki" or the laws and regulations of the country in which the research was conducted, whichever offers greater protection to the human subjects. If the standards of the country are used, the applicant must state in detail any differences between those standards and the Declaration of Helsinki and explain why the national standards offer greater protection to the human subjects.
Research begun before effective date November 19, 1986: FDA will accept studies which have been conducted outside the U.S. and begun before November 19, 1986, if the agency is satisfied that the data constitute valid scientific evidence (§860.7) and that the rights, safety, and welfare of human subjects have not been violated.
A PMA based solely on foreign clinical data and otherwise meeting the criteria for approval under this part may be approved if:
- the foreign data are applicable to the U.S. population and medical practice;
- the studies have been performed by clinical investigators of recognized competence; and
- the data may be considered valid without the need for an on site inspection by FDA or, if FDA considers such an inspection to be necessary, FDA can validate the data through an on site inspection or other appropriate means.
Applicants who seek approval based solely on foreign data are encouraged to meet with FDA officials in a presubmission meeting.
Additional guidance on FDA policy regarding the acceptance of foreign clinical data can be found in the following document.
How does the sponsor notify FDA of a change in address of the official correspondent for the PMA under review?
FDA will send all PMA correspondence only to the designated official correspondent of the PMA. The sponsor can change the name or address of the official correspondent by submitting an amendment to the PMA.
Yes, the sponsor must submit a PMA supplement and receive approval before the change in trade name can be implemented.
Can the sponsor sell the PMA to another company? How does the owner notify FDA of a change in ownership?
Yes, a PMA may be sold to another company. The sponsor must submit a PMA amendment to notify FDA of the new owner. The new sponsor is responsible for complying with the PMA regulatory requirements as well as all other applicable regulations such as registration, listing, quality system, and medical device reporting. The PMA reference number will remain the same.
Ownership of a PMA may be transferred at any time, i.e., before or after FDA approval. At the time of the transfer, the former owner should provide an original and a copy of a letter (preferably on the letterhead of the former owner and signed by an appropriate company official) to be used to notify FDA that all rights of the PMA have been transferred to the new owner.
If the PMA has been approved, the new owner need only report that the transfer of PMA ownership will not result in a change or modification that would require a submission of a PMA supplement (§814.39) or affect the conditions of approval applicable to the PMA. If changes are made that require a PMA supplement (§814.39) or affect the conditions of approval, the new owner must submit an appropriate PMA supplement and obtain written FDA approval before marketing the device.
The above amendment or supplement should also include:
- the effective date of the ownership transfer;
- a statement of the new owner’s commitment to comply with all the conditions of approval applicable to the PMA; and
- either a statement that the new owner has a complete copy of the PMA including all amendments, supplements, and reports or a request for a copy from the FDA files. FDA will provide a copy of the PMA under the Freedom of Information fee schedule. [21 CFR 10.42]
A change in manufacturing or product sterilization site and certain changes to the device, labeling, or packaging require prior FDA approval through a PMA supplement. See PMA amendments and supplements for further guidance on when a PMA supplement is required.
If the transfer of ownership occurs before the PMA is approved, the PMA must be amended to include the applicable information and ownership transfer letter described above.
When the holder of an approved PMA enters into an agreement to permit another firm (hereafter referred to as the licensee) to manufacture and distribute a device under the licensee’s private label, FDA approval may be obtained by the following procedure:
The licensee may submit an original PMA that includes, or includes by authorized reference to the holder’s approved PMA, all appropriate information required by 21 CFR 814.20.
After the licensee’s PMA is approved, the original PMA holder may not rescind any authorization permitting the licensee’s use of information in the original approved PMA. The licensee may also use that same information in support of changes or modifications later proposed by the licensee. The licensee becomes independent of the original PMA holder and should submit all required PMA supplements and periodic postapproval reports directly to FDA.
The PMA submission must include the following:
- a statement signed by both parties confirming that the original PMA holder has furnished the licensee with a complete copy of all manufacturing information in the approved PMA applicable to the licensee’s manufacture of the device;
- a complete description of a licensee’s manufacturing facilities and a listing and explanation of all differences between the original PMA holder’s and the licensee’s methods and controls used in the manufacture, processing, packing, storage, and, when appropriate, installation of the device;
- process validation and expiration dating information, where appropriate;
- copies of all required labeling (draft or final) and a description of all differences between the PMA holder’s and the licensee’s labeling (e.g., a markup of the PMA holder’s approved labeling identifying the revisions incorporated in the licensee’s labeling;
- a description and the results of all tests and evaluations which demonstrate that the licensee’s device is identical or sufficiently similar to the PMA holder’s device to the extent that there is reasonable assurance that the licensee’s device is safe and effective for the intended use; and
- the licensee’s FDA establishment registration number and, if applicable, the dates of the most recent FDA inspection of the licensee’s manufacturing facility.
Yes, however, the sponsor must receive FDA approval of the new manufacturing site prior to distributing product that was manufactured at the new facility. For additional information about PMA Manufacturing Site Change Supplements, contact the Field Inspections Support Branch in the Division of Analysis and Program Operations (DAPO), Office of Compliance, at 301-796-5530.
If FDA has previously reviewed and accepted a protocol for changes to the expiration date and testing was performed in accordance with that protocol, the change to the expiration date can be made and reported in an annual report. If not, a PMA supplement should be submitted.
Before FDA approves or disapproves a PMA, FDA will not disclose the existence of the PMA unless it previously has been publicly disclosed or acknowledged. Even if the existence of the PMA has been publicly disclosed or acknowledged, data or information contained in the file are not available for public disclosure. However, FDA may disclose a summary of portions of the safety and effectiveness data, if disclosure is relevant to public consideration of a specific pending issue. [21 CFR 814, 21 CFR 20]
Upon approval (or denial of approval) of any PMA, FDA will publicly reveal the existence of the PMA and provide a detailed summary of the information submitted to FDA about the safety and effectiveness of the device. The approval order, summary of safety and effectiveness, and product labeling are available on the Internet and are linked from the searchable PMA database.
In addition, the following types of information in the PMA file are available for public disclosure after deletion of any trade secret, confidential commercial or financial information, or any other information that if disclosed would constitute a clearly unwarranted invasion of personal privacy, e.g., personnel, medical, and similar information. The releasable information includes:
- all safety and effectiveness data and information previously disclosed to the public;
- any protocol for a test or study;
- any adverse reaction report, product experience report, consumer complaint, and other similar data and information;
- a list of components previously disclosed to the public;
- an assay method or other analytical method; and
all correspondence and written summaries of oral discussion relating to the PMA file.
The following types of information are not available for public disclosure unless they have been previously disclosed to the public, relate to a device for which a PMA has been abandoned, or no longer represent a trade secret or confidential commercial or financial information:
- manufacturing methods or processes including quality control procedures;
- production, sales, distribution, and similar data and information; and
- quantitative or semiquantitative formulas.
[21 CFR 814 and 21 CFR 20]