[Federal Register: April 26, 1999 (Volume 64, Number 79)] [Notices] [Page 20312-20313] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr26ap99-115] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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 -------------------------------------------------------------------------------------------------------------------------------------------------------- Date of Publication in the Name of Document Date of Issuance1 Federal Register Federal Register cite -------------------------------------------------------------------------------------------------------------------------------------------------------- -------------------------------------------------------------------------------------------------------------------------------------------------------- Guidances -------------------------------------------------------------------------------------------------------------------------------------------------------- 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) -------------------------------------------------------------------------------------------------------------------------------------------------------- Notices -------------------------------------------------------------------------------------------------------------------------------------------------------- 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'' -------------------------------------------------------------------------------------------------------------------------------------------------------- Rulemakings -------------------------------------------------------------------------------------------------------------------------------------------------------- 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 -------------------------------------------------------------------------------------------------------------------------------------------------------- \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