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 18,000 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:
- 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.
As discussed elsewhere in this report under MDUFMA, OHIP successfully met our deadlines under MDUFMA with regards to Small Business activities:
- served as the lead within CDRH for the MDUFMA Small Business Determination (SBD), processing 135 SBD requests (125 were granted and 10 were denied);
- prepared a guidance document entitled: Guidance for Industry and FDA: FY 2003 MDUFMA Small Business Qualification Worksheet and Certification (this guidance will be updated each year); and
- presented a live broadcast on instructions for filling out the MDUFMA cover sheet.
The other 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 services 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:
Automated Call Center : We maintain an automated call center to provide superior customer service. 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 20,000 e-mail inquiries per year. In addition, we receive approximately 2,000 written/fax inquiries per year.
- 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 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.
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 requestors to access over 700 CDRH publications via the facsimile 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 2003, approximately 2,500 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% are accessible electronically, our stakeholders still request hardcopies. In FY 2003, approximately 100,000 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 26,000 hits in FY 2003.
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 100,000 hits in FY 2003. 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 2003, we modified topics to include the following information:
- new 510(k) Review Fee page;
- new PMA Review Fee page;
- new section on PMAs which provides a complete revision of the PMA manual with updated information including modular reviews;
- information on CDRH workshops;
- updates to three pages to include links to the new Office of In Vitro Diagnostic Device Evaluation and Safety website; and
- updates to the labeling page which add references to two new guidance documents.
During FY 2003, OHIP partnered with other organizations in presenting 15 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);
- Western New York Technology Council;
- AdvaMed; and
- Medical Design & Manufacturing (MD&M)
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:
- Guidance for Industry and FDA: FY 2003 MDUFMA Small Business Qualification Worksheet and Certification; and,
- Implementation of the Inspection by Accredited Persons Program under MDUFMA.