FDA Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 007

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing a publication containing modifications the agency is making to the list of standards FDA will recognize for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled “Modifications to the List of Recognized Standards, Recognition List Number: 007” (recognition list number: 007), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

DATES:

The recognition of standards announced in this document will become effective October 2, 2002. Submit written comments concerning this document at any time.

ADDRESSES:

Submit written requests for single copies on a 3.5″ diskette of “Modifications to the List of Recognized Standards, Recognition List Number: 007” to the Division of Small Manufacturers Assistance (DSMA), Center for Devices and Radiological Health (CDRH) (HFZ-220), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive labels to assist that office in processing your requests, or fax your request to 301-443-8818. Submit written comments concerning this document to the contact person (see FOR FURTHER INFORMATION CONTACT). Identify comments with the docket number found in brackets in the heading of this document. You may access this document on FDA's Internet site at http://www.fda.gov/cdrh/fedregin.html . See section V of this document for electronic access to the searchable database for the current list of “FDA Recognized Consensus Standards,” including recognition list number: 007 modifications, and other standards related information.

FOR FURTHER INFORMATION CONTACT:

Carol L. Herman, Center for Devices and Radiological Health (HFZ-84), Food and Drug Administration, 2094 Gaither Rd., Rockville, MD 20850, 301-594-4766, ext. 156.

SUPPLEMENTARY INFORMATION:

I. Background

Section 204 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Public Law 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360d). Amended section 514 of the act allows FDA to recognize consensus standards, developed by international and national organizations, for use in satisfying portions of device premarket review submissions or other requirements.

In a notice published in the Federal Register of February 25, 1998 (63 FR 9561), FDA announced the availability of guidance entitled “Recognition and Use of Consensus Standards.” This notice described how FDA will implement its standards program recognizing the use of certain standards and provided the initial list of recognized standards.

In Federal Register notices published on October 16, 1998 (63 FR 55617); July 12, 1999 (64 FR 37546); November 15, 2000 (65 FR 69022); May 7, 2001 (66 FR 23032), and January 14, 2002 (67 FR 1774), FDA modified its initial list of recognized standards. These notices described the addition, withdrawal, and revision of certain standards recognized by FDA.

FDA maintains the agency's current list of “FDA Recognized Consensus Standards” in a searchable database that may be accessed directly at FDA's Internet site at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm . FDA will incorporate the modifications and minor revisions described in this notice into the database and this recognition of consensus standards will be effective upon publication in the Federal Register. FDA will announce additional modifications and minor revisions to the list of recognized consensus standards, as needed, in the Federal Register once a year, or more often, if necessary.

For each of the recognized standards, FDA provides in the database a supplementary information sheet that includes information such as:

1. Devices affected by the standard;

2. Processes affected by the standard (premarket notification (510(k), premarket approval (PMA), investigational device exemption (IDE), product development protocol (PDP), and quality systems regulation (QSR));

3. Extent of recognition (all or part of the standard, for what purpose the standard is recognized);

4. Related citations in the Code of Federal Regulations that identify the devices covered;

5. Related product codes that are used by FDA to identify the devices covered; and

6. Guidances relevant to the devices affected by the standard.

II. Modifications to the List of Recognized Standards, Recognition List Number: 007

FDA is announcing the addition, withdrawal, correction, and revision of certain consensus standards the agency will recognize for use in satisfying portions of premarket review submissions for devices. FDA will incorporate these modifications in the list of “FDA Recognized Consensus Standards” in the agency's searchable database. FDA is also establishing two new categories of recognized standards: (1) “Materials” and (2) “tissue engineering” standards. The tables below reflect the changes FDA is making to the list of recognized standards. These changes include:

• Withdrawn and replaced with a newer version
• Withdrawn and transferred to materials
• Contact person
• Transition statement added to the extend of recognition
• Citations and product codes
• Withdrawn
• Title correction
• Product codes and relevant guidance
• Devices affected
• Devices affected and type of standard

The following tables are divided by standards categories, include the two new categories of materials and tissue engineering standards, and identify the old item number, the name of the standard, the specific change, and the new replacement number, if any.

A. Biocompatibility

B. Cardiovascular/Neurology

C. Dental/ENT

D. General

E. General Hospital/General Plastic Surgery

F. Materials

G. Obstetrics and Gynecology (OB-GYN)/Gastroenterology

H. Orthopaedics

I. Physical Medicine

J. Radiology

K. Sterility

III. Listing of New Entries

FDA is adding new entries to the list of recognized standards as follows:

A. Biocompatibility

B. Cardiovascular/Neurology

C. Dental/Ear, Nose, and Throat (ENT)

D. General Hospital/General Plastic Surgery

E. In Vitro Devices

F. Materials

G. OB-GYN/Gastroenterology

H. Ophthalmic

I. Radiology

J. Sterility

IV. Recommendation of Standards for Recognition by FDA

Any person may recommend consensus standards as candidates for recognition under section 514 of the act by submitting such recommendations, with reasons for the recommendation, to the contact person (see FOR FURTHER INFORMATION CONTACT). To be properly considered, such recommendations should contain, at a minimum, the following information: (1) Title of the standard, (2) any reference number and date, (3) name and address of the national or international standards development organization, (4) a proposed list of devices for which a declaration of conformity to this standard should routinely apply, and (5) a brief identification of the testing or performance or other characteristics of the device(s) that would be addressed by a declaration of conformity.

V. Electronic Access

In order to receive “Guidance on the Recognition and Use of Consensus Standards” via your fax machine, call the CDRH Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter the system. At the second voice prompt press 1 to order a document. Enter the document number 321 followed by the pound sign (#). Follow the remaining voice prompts to complete your request.

You may obtain a copy of “Guidance on the Recognition and Use of Consensus Standards” by using the Internet. CDRH maintains a site on the Internet for easy access to information including text, graphics, and files that you may download to a personal computer with access to the Internet. Updated on a regular basis, the CDRH home page includes this guidance as well as the current list of recognized standards and other standards related documents. After publication in the Federal Register, this notice announcing “Modifications to the List of Recognized Standards, Recognition List Number: 007” will be available on the CDRH home page. You may access the CDRH home page at http://www.fda.gov/cdrh . You may access “Guidance on the Recognition and Use of Consensus Standards,” and the searchable data base for “FDA Recognized Consensus Standards,” through hyperlinks at http://www.fda.gov/cdrh/stdsprog.html . This Federal Register notice of modifications in FDA's recognition of consensus standards will be available, upon publication, at http://www.fda.gov/cdrh/fedregin.html .

VI. Submission of Comments

You may, at any time, submit to the contact person (see FOR FURTHER INFORMATION CONTACT) written comments regarding this document. You should submit two copies of any comments, except that individuals may submit one copy. You must identify comments with the docket number found in brackets in the heading of this document. FDA will consider any comments received in determining whether to amend the current listing of “Modifications to the List of Recognized Standards, Recognition List Number: 007.”