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FDA Promotes Shorter PMA Summaries, Faster Inspections : Shorter Device Inspections Tested : Yet Another Inspection Technique : FDA Web Link to Companies? : Five Reforms Emerge from FDA Stakeholders Process : Communications Change Boosts Dialogue

Medical Device & Diagnostic Industry Magazine
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An MD&DI December 1998 Column

WASHINGTON WRAP-UP

Simplifying requirements appears to be a current theme at the agency.

Also:

In an example of what seems to be a trend within FDA, the agency's Center for Devices and Radiological Health (CDRH) is reducing the length of the safety and effectiveness summaries that it issues with each new premarket approval (PMA). According to Susan Alpert, director of the Office of Device Evaluation (ODE), the goal is to make the summaries—which start out as proposed texts drafted by each PMA sponsor—more usable for the health professionals, procurement agencies, and others who read them.

In the case of some of the lengthier summaries customarily issued, Alpert anticipates more than a 50% cut in volume—dropping from approximately 50 pages for a recent excimer laser summary down to about 20 pages, for example. "I want them to be readable, pithy," she explains. "Rather than describe preclinical studies in narrative, do it in tabular form."

Alpert pointed out that a template for her approach already exists in the Division of Ophthalmic Devices, and although there's too much variation across device categories for a cookie-cutter approach to work, the concept is transferable to all ODE divisions.

Ophthalmic division director Ralph Rosenthal says that the shorter summaries being produced in his division could get even shorter; however, the three examples he selected emphasize elements that have been retained rather than those that have been abolished:

  • A summary for two excimer laser systems (VISX, Inc., Santa Clara, CA) that were approved on April 24, 1997. The summary ran to 28 pages and comprised the following sections: General Information, Indications for Use, Contraindications, Warnings and Precautions, Device Description, Alternative Practices or Procedures, Marketing History, Adverse Effects of the Device on Health, Summary of Preclinical Studies (a one-sentence reference to an earlier approval for a related indication), Summary of Clinical Studies (a two-page narrative plus 26 tables and captions and a description of adverse reactions), Panel Recommendations, FDA Decision, and Approval Specifications.
  • A summary for a posterior-chamber intraocular lens (Pharmacia, Inc., now Pharmacia & Upjohn, London), approved on July 20, 1995. This document was four pages long and contained sections titled General Information, Indications, Summary, Safety and Effectiveness Data (with three tables), and Conclusion.
  • A summary for a multipurpose solution for contact lenses (Eurexpan Labo, Washington, DC), approved on June 20, 1996. This consisted of four pages, with sections for General Information, Indications, Summary, and Safety and Effectiveness Data (with one table of clinical data).

Clearly, the length of a summary varies according to the sophistication of the device and the degree of risk inherent in its use. Alpert cites another factor: the tendency of sponsors to write the first version in an overly optimistic or promotional tone. CDRH then has to cut through the fluff and produce an objective document, a process that only adds to any delay.

In conjunction with the simplification process for PMA summaries, CDRH is also reducing the deficit of summaries (going back to 1994) that are supposed to be accessible on its Internet home page. On October 1, the day after the close of the 1998 fiscal year, three summaries of FY '97 approvals and six summaries of FY '98 approvals were still unavailable.

FDA field investigators are currently trying out a new and purportedly shorter inspection technique in three of the agency's field districts. Until December 31, the investigators will be pilot testing CDRH's new Quality Systems Inspections Technique (QSIT) in Minneapolis, Denver, and Los Angeles.

The new technique is intended to result in faster and more-targeted inspections and to help FDA live up to its mandate to inspect device manufacturers once every two years.

QSIT inspections will be comprehensive evaluations of manufacturers' quality systems and will not terminate early—as had been proposed by FDA to save resources—if investigators find "fatal flaws" at a company.

Under QSIT, investigators will evaluate four subsystems of the quality system regulation: management controls, design controls, corrective and preventive actions, and production and process controls.

The inspections will begin and end with an evaluation of management controls, according to CDRH reengineering inspection team leader Tim Wells. Conclusive decisions on management controls can't be performed, says Wells, until investigators have walked through each of the subsystems and determined that a firm's management has devoted sufficient resources to these controls.

Inspections will be preannounced, at which time the investigators will ask for voluntary production of the company's quality policy and top-level quality system procedures (including management review procedures, quality manual, quality plan, or equivalent documents). QSIT is designed so that only one investigator will inspect a device facility, rather than a team, Wells says.

It's still too early to tell if the new procedures will actually save any time. Since investigators began adding the new quality system and design control regulatory requirements to their inspections, FDA time in the plant has been extended to an average of 70 hours, almost double the 40-hour target maximum set out in agency policy for routine comprehensive device inspections.

While performing faster inspections is certainly a goal, says Wells, QSIT is also designed to produce more-focused inspections and to harmonize the process more closely with European inspections.

While the QSIT pilot program was getting under way, a second technique—based on principles of hazard analysis and critical control points (HACCP) that have been used in other industries for more than 30 years—was being developed at CDRH. HACCP will allow for inspections of participating firms based on the critical control points that can affect product safety.

The center expects industry and independent third-party organizations to play the major role in this effort, with CDRH providing direction and helping to kick off the program.

CDRH maintains that the technique will result in more efficient, streamlined inspections for participating companies and is considering allowing firms that voluntarily develop HACCP programs to use a symbol on their product labels indicating that they follow HACCP principles.

The seven HACCP requirements that form the basis of the protocol stipulate that companies:

CDRH has developed a chart showing how the seven principles tie in to elements in the quality system regulation and says the fact that they coincide means that new regulations are not necessary.

After the protocol is developed, a team at the agency will monitor the program to determine if it identifies critical problems with devices more efficiently than traditional inspections, according to a CDRH document giving current thinking on HACCP inspections.

CDRH is following the HACCP model developed by the National Seafood HACCP Alliance, which became a requirement for seafood processors in December 1997.

The center urges medical device manufacturers to receive necessary HACCP training so that they will be able to develop a plan. At present, no training course is designed specifically for medical devices, but industry representatives can attend seafood alliance courses. At two of these sessions, a member of the CDRH HACCP team has presented additional information pertaining to medical devices. (Editor's note: for more information, see our related story, Developing an HACCP Plan.)

One thing CDRH could do to maximize the dissemination of new product information would be to devote a special section of its Internet home page to hyperlinks to the Web sites of device manufacturers, suggested the Medical Device Manufacturers Association in September 10 comments to the agency.

It was the second time in a week that the agency had been asked to consider linking its page to company pages. At a previous internal agency meeting on Internet issues, the same suggestion was offered as a way of providing access to company responses to warning letters and untitled letters. However, that idea was soon rejected as too costly.

FDA has distilled to five main themes the hundreds of requests and suggestions it received during its recent "stakeholder" meetings, deputy commissioner for strategic management Linda A. Suydam says. These five principles are:

It's the biggest change I've seen in my five years here," says ODE director Susan Alpert, referring to a new series of intermanagement meetings the center is having with device sponsors to optimize its industry-agency communications. She declined to identify the companies, but says that five such meetings have been held, involving multiple levels of management on both sides. The goal of the process is to enable FDA and industry to work together more effectively and to better understand each other's philosophical outlook.


Copyright ©1998 Medical Device & Diagnostic Industry

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