About FDA

FY 2000 OHIP Annual Report - Manufacturer Support

Safe and effective medical devices are crucial to our healthcare system. FDA regulated medical devices include over 100,000 different types of products in more than 1,700 product categories. They range from simple everyday articles such as thermometers, tongue depressors and heating pads to more complex devices such as pacemakers, defibrillators and kidney dialysis machines. Overall, medical devices are becoming increasingly complex. Improved, life-saving devices are using innovations such as microprocessor control, artificial intelligence, miniaturization and remote operation.

Members of the medical device industry are just as diverse as the products that they manufacture:

there are approximately 15,000 manufacturers of medical devices worldwide;
more than 70 percent of medical device manufacturers are small enterprises with fewer than 50 employees; and,
more than 40 percent of device firms manufacture abroad.

This complexity and diversity present a challenge to FDA as a regulatory and public health agency. They also present a challenge to the medical device manufacturers who must comply with FDA regulations. Better communication between FDA and manufacturers opens the door for improved understanding, provides for a better working relationship, and results in quicker access to devices by the public.

Goals

To provide technical assistance in meeting FDA requirements for medical devices and radiation-emitting electronic products.
To develop informational materials and to provide accessible, efficient channels for distributing information to manufacturers.
To respond to manufacturer inquiries in a comprehensive and timely manner.

Small Business Activities

FDA has instituted a number of activities aimed specifically at increasing communication with the small business community. In addition to Small Business Assistance Programs that reside in each of the six FDA field offices, each Center in FDA has a special small business unit.

Within CDRH, OHIP serves as a focus for small business concerns. We strive to:

identify ways in which FDA requirements can protect and promote the public health without being unfair or unduly burdensome to small business;
encourage greater participation by small firms in the regulatory process itself, especially at the early stage when comments are sought on proposals that impact on the device industry; and
educate CDRH staff on the needs of medical device manufacturers and potential problems they face in meeting FDA’s regulatory requirements.

General
Information
Package

We provide 2,000
General Information
Packages each year to
new companies entering
the device industry. to
obtain a copy of this
package, fax your request
to 301-443-8818.

The specific types of assistance that we provide to small businesses are similar to those that we provide to other domestic and foreign manufacturers of medical devices. These are discussed in more detail below.

Assisting Manufacturers

The most fundamental assistance that OHIP provides to manufacturers involves our response to individual inquiries, questions and concerns. We do this through several mechanisms, including:

Automated Call Center: The system used for our call center was updated in FY1999 and work on the system continued in FY2000. As a result of these upgrades, we were able to implement additional customer service features including call queuing. This advises the caller of their place in the queue and the average wait time. While in queue the caller hears messages about issues of interest to CDRH stakeholders. The caller can stay on the line or select another option, such as leaving a voice mail or making another choice from the main menu. This system is available year round (see inset) and offers manufacturers the opportunity to speak directly to a device specialist who can answer their questions and direct them to the needed information. We typically receive an average of 40,000 telephone inquiries per year.
E-mail: All of our webpages for manufacturers include access to our e-mail account – dsma@cdrh.fda.gov. We respond to an average of 9,000 e-mail inquiries per year. Although declining in numbers we still receive an average of 2,500 written/fax inquiries per year.

OHIP/CDRH

Division of Small
Manufacturers
Assistance

800-638-2041

301-443-6597

Automated Assistance
available 24/7

Device Specialists
available M-F

8 a.m. to 5 p.m., EST

510(k) Status Program: We assist manufacturers in determining the status of their pending premarket notification applications (510(k)). Requests for this service have decreased dramatically as CDRH eliminated the backlog of 510(k) applications. However, we still receive approximately 550 requests each year. The link on the left provides instructions on using this program.
Broadcast Fax: OHIP uses an automated fax system to rapidly distribute important CDRH information to our industry. We also distribute information to stakeholder organizations such as AdvaMed, RAPS and FDLI who then provide a multiplier effect. During FY1999 and FY2000 we distributed information on several topics, including a letter to the medical glove industry announcing the Glove Powder Proposal; Y2K leap year announcements; and upcoming workshops/conferences on Reuse of single use devices.

Facts on Demand (FOD): FOD is an automated answering system that allows you to access over 1,200 CDRH publications through your FAX machine. Almost all of the documents available by FOD are more easily available from our webpage. However, FOD is still used by some of our stakeholders. In FY2000 approximately 7,000 guidance documents were obtained through this system.
Hardcopy: OHIP is a warehouse to over 1,000 FDA publications. Although approximately 75 percent are accessible electronically, our stakeholders still request hardcopies. Over the last three years hardcopy distribution has decreased by 50 percent. In FY2000, approximately 40,000 publications were distributed either by hardcopy or on diskette.

CDRH
Facts on Demand

800-899-0381
301-827-0111

Catalog available on your fax machine after dialing the above number and:

Press 1 to enter the system and obtain documents
Press 2 to obtain instructions for using the system
Press INDX (4639 on the keypad) to request an index for all documents.

Manufacturers Assistance Webpage: Our webpage is a comprehensive source of information for manufacturers. It provides easy accessto the services we offer, issues of interest to manufacturers and copies of manuals and guidance documents.

Device Advice Webpage

Early on, we recognized both the advantages and the limitations of providing extensive information for manufacturers on our website. Often, just having "access" to all of our information doesn’t make it easy to find the particular document or information that you are seeking. Further, while you might find a particular document, you might not be aware of related documents or information.

To address these concerns, OHIP designed and implemented Device Advice. With Device Advice, you can determine:

whether the product you want to market is
a radiation-emitting electronic product,
a medical device,
both a radiation-emitting electronic product and a medical device, or,
neither a radiation-emitting electronic product nor a medical device;

the FDA reporting requirements and standards that may apply for a radiation-emitting electronic product;
the classification of the product, if it is a medical device;
the process for obtaining appropriate clearance to market the medical device; and
information on any other requirements that might apply to your product.

Device Advice is an interactive system that will guide you through the process of obtaining FDA clearance to market a medical device and to meet FDA requirements for radiation-emitting electronic products.

Device Advice can also be used as a resource linking to regulatory manuals, precedence correspondence, import/export requirements, CDRH databases and a complete index for the Code of Federal Regulations (Title 21 CFR).

OHIP device specialists programmed the first "version" of Device Advice in 1998. Since then, it has consistently been one of the ten most used CDRH webpages. In FY1999, we modified topics to include the FDA Modernization Act. In FY2000, we developed two new sections on the Investigational Device Exemption (IDE) that include new information on meetings with FDA, Financial Disclosure of Clinical Investigators, Institutional Review Boards, Quality System requirements and Medical Device Recalls (Corrections and Removals). We are currently expanding the Premarket Approval (PMA) section.

Workshops/Presentations

During FY2000, OHIP partnered with other organizations in presenting eight workshops for manufacturers. The workshops allow us to meet with manufacturers face to face and to exchange information on topics such as regulatory requirements, Quality Systems, and import and export requirements. Our partners in presenting the workshops included:

Association for the Advancement of Medical Instrumentation (AAMI),
Canon Communications,
Regulatory Affairs Professional Society (RAPS),
Food and Drug Law Institute (FDLI),
Atlantic Food and Drug Officials (AFDO), and
Western New York Technical Development Center.

Developing Guidance for Manufacturers

In addition to facilitating manufacturers’ access to all CDRH guidance documents, OHIP staff also prepare guidance documents in their areas of expertise. These guidance documents may be prepared entirely within OHIP or in collaboration with staff from other CDRH Offices. Recent guidance documents include:

Draft Guidance for Industry and FDA, Medical Glove Guidance Manual. July 30, 1999
Guidance for Industry and FDA: Regulation of Medical Devices: Background Information for International Officials. April 14, l999
Draft Guidance for Staff, Industry and Third Parties: Implementation of Third Party Programs Under the FDA Modernization Act of 1997. June 12, 2000
Guidance for Staff, Industry and Third Parties: Third Party Programs Under the Sectoral Annex on Medical Devices to the Agreement on Mutual Recognition Between the United States of America and the European Community (MRA). January 6, 1999
Draft Guidance for Staff, Industry and U.S./EU CABs; Implementation Plan for the MRA between the EU and the USA: Confidence Building Program: Overview, Medical Device Annex, Version 7. June 29, 2000
Draft Guidance for Staff, Industry and U.S./EU CABs; Implementation Plan for the MRA between the EU and the USA: Confidence Building Program: Procedures, Medical Device Annex, Version 7. June 29, 2000

OHIP plans to update the Premarket Notification 510(k) Regulatory Requirements Manual in FY2001.

Accredited Persons Program

OHIP administers the Accredited Persons Program for CDRH. This program allows manufacturers to use "Third Parties" to conduct initial review of premarket notification (510(k)) submissions for low (Class I) to moderate (Class II) risk devices. The Third Parties are individuals or organizations who meet qualifications and requirements established by FDA and who are then "accredited" to do these reviews. This program has the potential to provide manufacturers with more rapid clearance decisions for their devices. At the same time, FDA would be able to focus its resources on higher risk devices.

Both FDA and the medical device industry have been disappointed that the Accredited Persons Program has not been used more. Therefore, OHIP has worked closely with the Office of Device Evaluation to significantly expand the scope of the third party program in FY2000:

the list of eligible devices was updated on June 12, 2000, adding an additional 57 devices;
in a June 12, 2000 draft guidance document we proposed a pilot program that would make an additional 460 Class II devices eligible for third party review;
we worked with FDA’s Office of Regulatory Affairs to develop an audit program for the Accredited Persons;
we prepared a Report to Congress on the "Inclusion of Certain Devices Within the Accredited Persons Program - Third Party Review of Clinical Data; and
we are currently reviewing public comments to the draft guidance document and expect to issue final guidance early in 2001 that will significantly expand the number of devices eligible for the program.

Taken together, updating the list of eligible devices and implementation of the expansion pilot program will represent more than a 300 percent increase in the number of eligible devices.