Navigating Recent Changes To The Medical Device User Fee Modernization Act of ‘02

Navigating Recent Changes To The Medical Device User Fee Modernization Act of ‘02

 

Rames R. Ravitz James Hartten

Since the summer, there has been a flurry of regulatory activity with respect to the amendment and implementation of the Medical Device User Fee Modernization Act of 2002 (MDUFMA).  

Significantly, on August 1, 2005, the Medical Device User Fee Stabilization Act (MDUFSA) was signed into law to amend certain provisions of MDUFMA, including raising the monetary threshold for qualifying for the small business exemption.

MDUFSA also modifies Section 301 of MDUFMA with regard to the labeling of single-use medical devices.  FDA has also issued several guidance documents intended to provide the medical device industry with clarity on the labeling of “reprocessed” single-use devices and the eligibility requirements for device manufacturers interested in participating in a third party inspection program.  

These important developments are discussed below.

 

User Fees

Since the passage of MDUFMA, and the implementation of medical device user fees in FY 2004, the full cost of filing a pre-market approval application has risen from $206,811 in FY 2004, to a cost of $259,600 in FY 2006.

During this same period, the cost of submitting a 510(k) application to FDA has risen from $3,480 in FY 2004 to $3,833 in FY 2006.

Congress expected the user fees to shorten application review times by providing FDA with additional money to expand and better equip the Office of Device Evaluation’s various reviewers.  

To date, however, there has been very little tangible improvement in shortening the duration of the application review process.  

Indeed, this lack of improvement has become a continuing source of frustration to industry, particularly as user fees continue to rise.

Against this backdrop, MDUFSA was enacted to provide some measure of relief to the device industry.  

MDUFSA raised the threshold for meeting the small business exemption, which provides companies with the benefit of reduced application fees, from $30 million to $100 million.  

Companies who report gross receipts or sales of $100 million or less (including receipts and sales from parents, partners and affiliates) on their most recent federal income tax return, can qualify for this exemption.  

Under MDUFSA, “small businesses” would pay, for example, $98,648 for the filing a full PMA and $3,066 when submitting a 510(k). 

Reprocessed Single Use Devices

MDUFSA amended MDUFMA’s highly controversial Section 301, which required all single-use devices to bear the name of the manufacturer clearly and conspicuously on a label.

Under MDUFSA, now only manufacturers of “reprocessed” single-use devices are required to comply with this provision.  While this satisfied many original equipment manufacturers (OEM), the issue of how to comply with Section 301 was unresolved, at least for reprocessors.  

In response, FDA issued a guidance on October 11, 2005, that clarifies how a manufacturer may comply with the revised Section 301.(#1)

According to the guidance, manufacturers of reprocessed single-use devices may identify themselves one of several ways depending on the circumstances.

First, if the OEM’s name or mark is on the reprocessed device, the reprocessor must add its name or mark to the device itself.  

Second, if the device lacks the appropriate room, the reprocessor’s name or mark should be added to the device using some form of attachment, such as a tag or sticker, which cannot be removed inadvertently.  

Third, in cases where the OEM’s name or mark does not appear on the reprocessed device, the device reprocessor can either add its name or mark to the device or use a detachable label on the device’s packaging.  

If a detachable label is used, the intent is for the label to be affixed by the user of the device (e.g., doctor or nurse) to the medical record of the patient on whom the device is used.  

With respect to satisfying the “prominently and conspicuously” requirement, the guidance establishes the following 4-part labeling criteria: (1) the space available on the device packaging should be sufficient to allow for placement of the “name” so that it can be recognized under ordinary conditions of use; (2) there should be sufficient contrast between the packaging background and the printed “name” to make the appearance of the name clearly apparent to the user; (3) the print type or font used for the name should be of a size and style that device users can easily read; and (4) the “name”, “abbreviated name” or “mark” printed on the packaging should be sufficient to identify the device manufacturer (i.e., a generic mark or abbreviation not commonly associated with the manufacturer should not be used).   

The labeling requirement goes into effect on August 1, 2006.  

Third Party Inspections

On September 4, FDA published industry guidance establishing eligibility requirements for device manufacturers interested in participating in a third party inspection program commonly referred to as “Inspection by Accredited Persons Program” (“AP Inspection”).  

The AP Inspection program, which was authorized under Section 201 of MDUFMA, is a voluntary third-party inspection program applicable to device manufacturers who meet certain eligibility criteria, as discussed below.  

In sum, manufacturers who qualify for the AP Inspection program can use FDA-accredited, third party inspectors to conduct their facility inspections in lieu of having the agency conduct its own inspection.  Manufacturers can benefit from participating in the AP Inspection program because they have greater control over the timing of their inspections.  

Further, a number of FDA-accredited inspectors are also recognized by other countries as persons authorized to conduct inspections of device establishments.  

Thus, in some cases, a single AP Inspection will meet the requirements of more than one regulatory authority, thereby reducing the need for multiple inspections of the same establishment.

Manufacturers who meet the following requirements are eligible to participate in the AP Inspection program.  

First, a manufacturer must currently market at least one Class II/Class III medical device in the U.S., and also market or plan to market at least one such device in one or more foreign countries.  

Second, a manufacturer’s most recently completed FDA inspection or AP Inspection must have resulted in either a “No Action Indicated” (NAI) or “Voluntary Action Indicated” (VAI) inspection.  

Third, manufacturers must submit a notice to FDA requesting permission to use an AP Inspector.  

Last, AP Inspectors are limited to conducting a series of partial inspections on a given facility that cumulatively count as one complete inspection.  

Any additional AP Inspections beyond one completed inspection would require issuance of a waiver by the agency.  Interested parties can find a list of approved third party inspectors on FDA’s CDRH website.

The enactment of MDUFSA and the recent guidances issued by FDA continue to shape MDUFMA.  

While MDUFSA tacked two additional years onto the life user fee program, Congress must reauthorize the user fee program in order to extend it beyond the sunset date of September 30, 2007.  Reauthorization of MDUFMA will no doubt prove to be a subject of more debate and controversy.

1. Compliance with Section 301 of the Medical Device User Fee and Modernization Act of 2002, as amended – Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices”, CDRH, FDA (October 11, 2005).

James R. Ravitz is an attorney and James H. Hartten is a regulatory affairs analyst with Arent Fox PLLC, a general practice law firm based in Washington, D.C. For additional information, contact: [email protected] or (202) 857-8903.