[Federal Register Volume 64, Number 79 (Monday, April 26, 1999)]
[Notices]
[Pages 20312-20313]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-10290]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99N-0924]


Food and Drug Administration Modernization Act of 1997; List of 
Documents Issued by the Food and Drug Administration That Apply to 
Medical Devices Regulated by the Center for Biologics Evaluation and 
Research

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is publishing a list 
of documents issued in response to the Food and Drug Administration 
Modernization Act of 1997 (FDAMA), and clarifying their applicability 
to medical devices regulated by the Center for Biologics Evaluation and 
Research (CBER). This notice is intended to inform the public of the 
availability of these documents, clarify their scope of applicability, 
and to provide instructions on ways to access them.

ADDRESSES:  Submit written requests for single copies of the document 
to the Division of Small Manufacturers Assistance (HFZ-220), Center for 
Devices and Radiological Health (CDRH), 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. The document may also be obtained by fax by 
calling the CDRH Facts-on-Demand at 1-800-899-0381 or 301-827-0111. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
documents.

FOR FURTHER INFORMATION CONTACT:  Astrid L. Szeto, Center for Biologics 
Evaluation and Research (HFM-17), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    On November 21, 1997, the President signed into law FDAMA (Pub. L. 
105-115). CBER is working closely with CDRH in the implementation of 
the provisions of FDAMA applicable to medical devices. However, early 
in the implementation of FDAMA, several documents were issued with 
explicit applicability to CDRH regulated devices, but for which 
applicability to CBER regulated devices was unclear. To clarify that 
these documents are also applicable to medical devices regulated by 
CBER, FDA is providing the public with this list of documents in 
section II of this document, acknowledging that the documents are 
utilized by CBER in its review of medical devices, and providing 
instructions on ways to access them. The documents in this list are 
applicable to any device regulated under the medical device amendments 
of the Federal Food, Drug, and Cosmetic Act (e.g., 510(k) exempt, 
510(k), premarket approval). CBER has endorsed these documents and 
intends to follow the procedures as appropriate.
    This list is organized by: (1) Guidances, (2) notices, and (3) 
rulemakings. Guidance documents that do not have a date and cite of 
publication in the Federal Register were issued directly on the 
Internet. Although certain documents on the list may reference specific 
organizational elements and contact points in CDRH, this should not be 
interpreted to mean that those are also the contact points for CBER. 
The general contact point in CBER for medical device issues will be the 
Associate Director for Regulatory Affairs in the Office of Blood 
Research and Review, CBER.

II. Document References

 
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                                                                                                     Date of Publication in the
                          Name of Document                                  Date of Issuance1             Federal Register        Federal Register cite
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Guidances
 
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Guidance on IDE Policies and Procedures2 (Level 2)                     January 20, 1998             N/A                          N/A
FDA Modernization Act of 1997: Guidance for the Device Industry on     February 6, 1998             February 6, 1998             63 FR 6193
 Implementation of Highest Priority Provisions
Determination of Intended Use for 510(k) Devices--Guidance for         January 30, 1998              February 25, 1998           63 FR 9570
 Industry and CDRH Staff
Guidance on the Recognition and Use of Consensus Standards             February 20, 1998            February 25, 1998            63 FR 9561
Early Collaboration Meetings Under the FDA Modernization Act           February 19, 1998            February 25, 1998            63 FR 9570
 (FDAMA), Guidance for Industry and CDRH Staff
Guidance on PMA Interactive Procedures for Day-100 Meetings and        February 19, 1998            February 25, 1998            63 FR 9570
 Subsequent Deficiencies--For Use by CDRH and Industry
30-Day Notices and 135-Day PMA Supplements for Manufacturing Method    February 19, 1998            February 25, 1998            63 FR 9570
 or Process Changes, Guidance for Industry and CDRH
New Section 513(f)(2)--Evaluation of Automatic Class III               February 19, 1998            February 25, 1998            63 FR 9570
 Designation, Guidance for Industry and CDRH Staff
Procedures for Class II Device Exemptions from Premarket               February 19, 1998            February 25, 1998            63 FR 9570
 Notification, Guidance for Industry and CDRH Staff
Guidance On Procedures to Determine Application of Postmarket          February 19, 1998            February 25, 1998            63 FR 9571
 Surveillance Strategies
Guidance on Procedures for Review of Postmarket Surveillance          February 19, 1998             February 25, 1998            63 FR 9571
 Submissions
Guidance on Medical Device Tracking                                    February 19, 1998            March 4, 1998                63 FR 10640
PMA/510(k) Expedited Review--Guidance for Industry and CDRH Staff     March 20, 1998                March 31, 1998               63 FR 15427

[[Page 20313]]

 
Guidance to Industry Supplements to Approved Applications for Class    May 20, 1998                 May 21, 1998                 63 FR 27988
 III Medical Devices: Use of Published Literature, Use of Previously
 Submitted Materials, and Priority Review
List of Devices for Third Party Review Under the FDA Modernization     February 8, 1999 (list       N/A                          N/A
 Act of 19972                                                          updated periodically)
List of Accredited Persons For 510(k) Review under the FDA             October 2, 1998 ( list       N/A                          N/A
 Modernization Act of 19972                                            updated periodically)
Guidance for Staff, Industry, and Third Parties: Implementation of     October 30, 1998             November 2, 1998             63 FR 58746
 Third Party Programs Under the FDA Modernization Act of 1997
Guidance on Criteria and Approaches for Postmarket Surveillance        November 2, 1998             November 3, 1998             63 FR 59315
Guidance for Industry: General/Specific Intended Use                   November 4, 1998             November 5, 1998             63 FR 59793
Guidance on Frequently Asked Questions on the Recognition and Use of   December 21, 1998            N/A                          N/A
 Consensus Standards2 (Level 2)
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Notices
 
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Medical Devices; Exemptions From Premarket Notification; Class II                                   January 21, 1998             63 FR 3142
 Devices
Medical Devices; Exemptions From Premarket Notification and Reserved                                February 2, 1998             63 FR 5387
 Devices; Class I
Medical Devices; Device Tracking; New Orders to Manufacturers                                       March 4, 1998                63 FR 10638
Prompt Review of Supplemental Applications for Approved Devices                                     May 21, 1998                 63 FR 27987
Modifications to the List of Recognized Standards; Availability;                                    October 16, 1998             63 FR 55617
 Withdrawal of Draft Guidance ``Use of IEC 60601 Standards; Medical
 Electrical Equipment''
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Rulemakings
 
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Medical Devices; Reports of Corrections and Removals; Direct Final                                  August 7, 1998               63 FR 42229
 Rule
Medical Devices; Reports of Corrections and Removals; Companion to                                  August 7, 1998               63 FR 42300
 Direct Final Rule; Proposed Rule
Medical Devices; Exemptions from Premarket Notification ; Class II                                  November 3, 1998             63 FR 59222
 Devices
Medical Devices; Exemption from Premarket Notification and Reserved                                 November 12, 1998            63 FR 63222
 Devices; Class I
Medical Devices; Investigational Device Exemptions; Final Rule                                      November 23, 1998            63 FR 64617
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\1\ The ``Date of Issuance'' is the date that the guidance was announced on the Internet.
\2\ Not applicable (N/A)--this document was not announced in the Federal Register. It was issued directly on the Internet.

III. Electronic Access

    Persons with access to the Internet may obtain the documents using 
the World Wide Web (WWW). For WWW access, connect to CBER at ``http://
www.fda.gov/cber/guidelines.htm'' for the guidance documents only. 
Connect to CDRH at ``http://www.fda.gov/cdrh'' for all of the documents 
listed.

    Dated: April 19, 1999.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 99-10290 Filed 4-23-99; 8:45 am]
BILLING CODE 4160-01-F