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 14,000 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.
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 five FDA regional 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:
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.
- identify ways in which FDA requirements can protect and promote the public health without being unfair or undulyburdensome 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.
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 in the following pages.
|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:
Division of Small
Automated Assistance available 24/7
8 a.m. to 5 p.m., EST
- Automated Call Center: We maintain an automated call center to provide superior customerservice. The call center 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 24 hours per day (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 and respond to an average of 35,000 telephone inquiries per year.
- E-mail: All of our webpages for manufacturers, and many other CDRH webpages, include access to our e-mail account – email@example.com. We respond to over 12,000 e-mail inquiries per year. In addition, we receive approximately 2,200 written/fax inquiries per year.
- 510(k) Status Program: We assist manufacturers in determining the status of their pendingpremarket 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 500 requests each year. The link to the left provides instructions on 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 FY 2001, we distributed information on several topics, including upcoming workshops/conferences on Reuse of single use devices, HACCP, and the Global Harmonization Study Group 1 "Medical Device Classification" document.
Facts on Demand
Catalog available on your fax machine after dialing the above number and:
- Press "1" to enter the system and obtain documents; or
- Press "2" to obtain instructions for using the system
- Press "INDX" (4639 on the keypad) to request an index for all documents.
- Facts on Demand (FOD): FOD is an automated answering system that allows you to access over700CDRH publications through your FAX machine. Almost all of the documents available by FOD are more easily available from the CDRH webpage. However, stakeholders still use FOD to obtain publications. In FY 2001, approximately 8,000 publications were obtained through this system. We continue to maintain this system by adding new guidance documents as they become available and removing the outdated documents.
- Publication Distribution: OHIP is a warehouse to over 1,000 FDA publications. Although approximately 80 percent are accessible electronically, our stakeholders still request hardcopies. In FY 2001, approximately 50,000 publications were distributed either by hardcopy or on diskette.
- Manufacturers Assistance Webpage: Our webpage is a comprehensive source of information for manufacturers. It provides easy access to the services we offer, issues of interest to manufacturers and copies of manuals and guidance documents. The site received 54,600 hits in FY 2001. In response to the large volume of this type of work performed by the division, OHIP officially renamed the Division of Small Manufacturers Assistance (DSMA) to the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) in July 2001 in an effort to more accurately describe the services we provide.
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. This webpage has been a successful source of information and received 59,326 hits in FY 2001. 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 of 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 FY 2001, we modified topics to include the following information:
- IDE Supplements
- PMA Supplements and Amendments Section
- Import for Export
- CLIA Section within the 510(k) Section
- CBER 510(k) Reviews
- Corrections and Removals
- Sunglass Guidance
- Quality Systems
- International Organization for Standardization (ISO)
|During FY 2001, OHIP partnered with other organizations in presenting 12 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 the following organizations:
- Association for the Advancement of Medical Instrumentation (AAMI)
- Canon Communications
- Regulatory Affairs Professional Society (RAPS)
- Association of Medical Diagnostic Manufacturers (AMDM)
- Medical Alley
- American Society for Quality (ASQ)
|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 Staff, Industry and Third Parties: Implementation of Third Party Programs Under the FDA Modernization Act of 1997. February 2, 2001.
- Sunglasses, Spectacle Frames, Spectacle Lens and Magnifying Spectacles. June 19, 2001.
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 Accredited Persons (AP’s) 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 AP program in FY2001. Specifically, the following efforts took place in order to address this concern:
- In February 2001, we implemented an expansion pilot that allows AP’s to review Class II devices for which there are no device-specific guidance documents. Implementation of the pilot expanded the number of eligible devices to 674 by adding over 450 Class II devices. Implementing the expanded pilot program represents more than a 300% increase in eligible devices. Also, there was an increase in third party submissions of 510(k)s by AP’s of almost 130% in FY 2001.
- In February 2001, we issued a final guidance document that includes criteria allowing for the review of the Class II pilot devices, entitled Guidance for Staff, Industry and Third Parties: Implementation of Third Party Programs Under the FDA Modernization Act of 1997.
- In June 2001, we conducted the second training session for third parties since the Accredited Persons Program began in 1998.
- In July 2001, we drafted a letter that was issued on September 17, 2001 from Secretary Thompson to Congresspersons W.J. Tauzin and Edward Kennedy advising them that we reached milestones that exceed those in the "sunset provision of FDAMA. This provision specifies that authorization of the program will end 5 years from the date of the letter.