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Federal Register Notices Concerning MDUFMAUpdated through Federal Register of September 9, 2004Most-Recent Notices Listed First (Reverse Chronological Order) |
Date | Subject | Citation | Comment/Action Date |
---|---|---|---|
8/2/2004 |
Establishment of Medical Device User Fee Rates for Fiscal Year 2005. | — |
|
7/9/2004 |
Agency Emergency Processing Under OMB Review; Application for Participation in the Medical Device Fellowship Program (Form FDA 3608). | Comment period closed. (Comments were due by 8/9/2004) |
|
6/24/2004 |
Definition of primary mode of action for a combination product. | Comment period closed. (Comments were due by 8/20/2004) |
|
6/21/2004 |
Request for comments on possible barriers to the availability of devices intended to treat or diagnose diseases and conditions that affect children. This information will help FDA prepare a report to Congress required by section 3 of the Medical Devices Technical Corrections Act; the report is due to Congress 9/28/2004. |
Comment period closed. (Comments were due by 8/20/2004) |
|
6/3/2004 |
Availability of Draft Guidance — Requests for Inspection by an Accredited Person Under the Inspections by Accredited Persons Program. This guidance is available at — |
Comment period closed. (Comments were due by 9/1/2004) |
|
6/1/2004 |
Availability of Guidance — Validation Data in Premarket Notifications for Reprocessed Single-Use Medical Devices. This guidance supersedes the guidance provided 7/8/2003 (see above). The current edition is available at — http://www.fda.gov/cdrh/mdufma/guidance/1511.pdf and http://www.fda.gov/cdrh/ode/guidance/1216.pdf |
Submit comments at any time. |
|
5/28/2004 |
Availability of Guidance — User Fees and Refunds for Premarket Notification Submissions (510(k)s). This guidance is available at — |
Submit comments at any time. |
|
5/21/2004 |
Availability of Guidance — FDA and Industry Actions on 510(k) Submissions – Effect on FDA Review Clock and Performance Assessment. This guidance is available at — |
Submit comments at any time. |
|
5/14/2004 |
Availability of Guidance — Premarket Assessment of Pediatric Medical Devices. Also see 7/24/2003 (availability of draft guidance). This guidance is available at — |
Submit comments at any time. |
|
5/7/2004 |
Proposed Rule — Definition of Primary Mode of Action for a Combination Product. | Comment period closed. (Comments were due by July 6, 2004) |
|
5/4/2004 |
Availability of Draft Guidance — Combination Products – Timeliness of Premarket Reviews – Dispute Resolution Guidance. This guidance is available at — www.fda.gov/OHRMS/DOCKETS/98fr/04d-0182-gdl0001.pdf |
Comment period closed. (Comments were due by July 6, 2004) |
|
4/13/2004 |
Semicritical Reprocessed Single-Use Devices; Termination of Exemptions from Premarket Notification; Requirement for Submission of Validation Data. Provides list of semicritical reprocessed single-use devices whose exemption from 510(k) is terminated, and for which validation data is now required in a 510(k). Also see 4/30/2003 (critical reprocessed single-use devices). |
Effective 4/13/2004; 510(k)s due 7/13/2005 |
|
2/17/2004 |
Announcing availability of revised MedWatch forms. The revised forms are available at — |
Prior versions of Forms 3500 and 3500A may be used until 8/17/2004. |
|
• 2/26/2004 — Correction — Provides omitted date. | 69 F.R. 9028 |
— |
|
1/9/2004 |
OMB Approval of Information Collection; MDUFMA Small Business Qualification Certification (Form FDA 3602). Approval expires December 31, 2006. Also see 7/18/2003 (60-day notice) and 10/10/2003 (submission to OMB). |
— |
|
12/9/2003 |
OMB Approval of Information Collection; Inspection by Accredited Persons Program Under MDUFMA. Approval expires November 30, 2006. Also see 7/10/2003 (60-day notice) and 10/8/2003 (submission to OMB). |
— |
|
11/26/2003 |
Availability of Guidance — Bundling Multiple Devices or Multiple Indications in a Single Submission. This guidance is available at — |
Submit comments at any time. |
|
11/26/2003 |
Availability of Guidance — Expedited Review of Premarket Submissions for Devices This guidance is available at — |
Submit comments at any time. |
|
11/24/2003 |
Availability of Guidance — User Fees and Refunds for Premarket Approval Applications. This guidance is available at — |
Submit comments at any time. |
|
11/6/2003 |
Availability of list of persons accredited to conduct Quality Systems / GMP inspections under MDUFMA. Also see 4/28/2003 (Availability of Guidance — Implementation of the Inspection by Accredited Persons Program Under MDUFMA; Accreditation Criteria). |
— |
|
11/3/2003 |
Availability of Guidance — Premarket Approval Modular Review. This guidance is available at — |
Submit comments at any time. |
|
10/10/2003 |
Submission of proposed information collection to OMB — MDUFMA Small Business Qualification Certification (Form FDA 3602). Revised version for use during FY 2004. Also see 7/18/2003 (60-day notice) and 1/9/2004 (OMB approval). |
Comment period closed. (Comments were due by 11/10/2003.) |
|
10/10/2003 |
OMB Approval of Information Collection; MedWatch Medical Products Reporting Program. FDA modified MedWatch forms to facilitate the reporting of information pertaining to reprocessed single-use devices. The existing MedWatch forms may be used for the next 6 months (though 4/6/2004). Approval expires March 31, 2005. Also see also 2/10/2003 (60-day notice) and 4/29/2003 (submission to OMB). |
— |
|
10/8/2003 |
Submission of proposed information collection to OMB — Inspection by Accredited Persons Program Under MDUFMA. Also see also 7/10/2003 (60-day notice) and 12/9/2003 (OMB approval). |
Comment period closed. (Comment were due by 11/7/2003.) |
|
9/29/2003 |
Notice of first Annual Stakeholder Meeting on Implementation of MDUFMA, to be held December 3, 2003. | Past event. (Registration ended 11/3/2003.) |
|
8/28/2003 |
OMB Approval of Information Collection; Submission of Validation Data for Reprocessed Single-Use Devices. Approval expires 1/31/2004. Also see 7/8/2003 (emergency submission to OMB). |
— |
|
8/25/2003 |
OMB Approval of Information Collection; Medical Device User Fee Cover Sheet (Form FDA 3601). Approval expires 8/31/2006. Also see 2/26/2003 (60-day notice) and 5/21/2003 (submission to OMB). |
— |
|
8/1/2003 |
Establishment of Medical Device User Fee Rates for Fiscal Year 2004. | — |
|
7/24/2003 |
Availability of Draft Guidance — Premarket Assessment of Pediatric Medical Devices. Also see 5/14/2004 (availability of final guidance). The final guidance is available at — |
Comment period closed. (Comments were due by 10/23/2003.) |
|
7/18/2003 |
Request for comments on proposed information collection — MDUFMA Small Business Qualification Certification (Form FDA 3602). (60-day notice.) Revised version for use during FY 2004. Also see 10/10/2003 (submission to OMB) and 1/9/2004 (OMB approval). |
Comment period closed. (Comments were due by 9/16/2003.) |
|
7/10/2003 |
Request for comments on proposed information collection — Inspection by Accredited Persons Program Under MDUFMA. (60-day notice.) Previously-approved information collection approval expires 9/30/2003; see 6/26/2003. Also see 10/8/2003 (submission to OMB) and 12/9/2003 (OMB approval). |
Comment period closed. (Comments were due by 9/8/2003.) |
|
7/8/2003 |
Agency Emergency Processing Under OMB Review; Submission of Validation Data for Reprocessed Single-Use Devices. Also see 8/28/2003 (OMB approval). |
Comment period closed. (Comments were due by 8/7/2003.) |
|
• 7/23/2003 — Correction — Corrects OMB contact information. |
— |
||
• 8/20/2003 — Correction — Corrects docket number. |
— |
||
7/8/2003 |
Availability of Guidance — Validation Data in Premarket Notification Submissions [510(k)s] for Reprocessed Single-Use Medical Devices. This guidance was revised 6/1/2004 (see below). The current edition is available at — |
Submit comments at any time. |
|
• 7/23/2003 — Correction — Corrects docket number. |
— |
||
6/26/2003 |
OMB Approval of Information Collection; Inspection by Accredited Persons Program Under MDUFMA. This approval expires 9/30/2003. Also see 4/28/2003 (emergency submission to OMB). |
— |
|
6/26/2003 |
Reprocessed Single-Use Devices; Termination of Exemptions from Premarket Notification; Requirement for Submission of Validation Data. Adds nonelectric biopsy forceps to the 4/30/2003 list of critical reprocessed single-use devices whose exemption from 510(k) is terminated, and for which validation data is now required in a 510(k). Also clarifies deadline dates shown in 4/30/2003 notice. Also see 4/30/2003 (original list of critical reprocessed single-use devices). |
Effective 6/26/2003; 510(k0s due 9/27/2004. | |
6/23/2003 | Availability of Draft Guidance — Compliance with Section
301 of MDUFMA – Identification of Manufacturer of Medical Devices. This
guidance is available at — |
68 F.R. 37161 | Comment period closed. (Comments were due by 9/22/2003.) |
6/3/2003 | Availability of Guidance — Pediatric Expertise for Advisory
Panels. This guidance is available at — |
68 F.R. 33166 | Submit comments at any time. |
5/21/2003 | Submission of proposed information collection to OMB — Medical
Device User Fee Cover Sheet; Form FDA 3601. Also see 2/26/2003 (60-day
notice) and 8/25/2003 (OMB approval). |
68 F.R. 27818 | Comment period closed. (Comments were due by 6/30/2003.) |
4/30/2003 | Critical Reprocessed Single-Use Devices; Termination of Exemptions
from Premarket Notification; Requirement for Submission of Validation Data.
Provides list of critical reprocessed single-use devices whose exemption from 510(k) is terminated, and for which validation data is now required in a 510(k). Also see 6/26/2003 (adding nonelectric biopsy forceps to the list of critical reprocessed single-use devices whose exemption from 510(k) is terminated, and for which validation data is now required in a 510(k) premarket notification), and 4/13/2004 (semicritical reprocessed single-use devices). |
68 F.R. 23139 | Effective 4/30/2003; 510(k)s due 7/30/2004; validation data for devices already cleared under 510(k) due 1/30/2004 |
4/29/2003 |
Submission of proposed information collection to OMB — MedWatch: The FDA Medical Products Reporting Program. Also see also 2/10/2003 (60-day notice) and 10/10/2003 (OMB approval). |
Comment period closed. (Comments were due by 5/29/2003.) |
|
4/28/2003 |
OMB Approval of Information Collection; Fiscal Year 2003 MDUFMA Small Business Qualification Certification (Form FDA 3602). This approval expires 10/31/2003 (form will not be used after 9/30/2003; see 7/18/2003 for notice on replacement form). Also see 3/26/2003 (emergency submission to OMB). |
— |
|
4/28/2003 |
Agency Emergency Processing Under OMB Review; Inspection by Accredited Persons Under MDUFMA. Also see 6/26/2003 (OMB approval). |
Comment period closed. (Comments were due by 5/28/2003.) |
|
4/28/2003 |
Availability of Guidance — Implementation of the Inspection by Accredited Persons Program Under MDUFMA; Accreditation Criteria. This guidance is available at — www.fda.gov/cdrh/mdufma/guidance/1200.pdf Also see 11/6/2003 (list of accredited persons). |
Submit comments at any time. |
|
3/27/2003 |
Availability of Guidance — Fiscal Year 2003 MDUFMA Small Business Qualification Worksheet and Certification. (This guidance announced in this Notice is now obsolete; it was replaced by new guidance for FY 2004. Because the FY 2004 guidance is a Level 2 guidance, no Federal Register Notice was required.) The FY 2004 guidance is available at — |
Submit comments at any time. |
|
3/26/2003 |
Agency Emergency Processing Under OMB Review; Fiscal Year 2003 MDUFMA Small Business Qualification Certification (Form FDA 3602). Also see 4/28/2003 (OMB approval). |
Comment period closed. (Comments were due by 4/25/2003.) |
|
2/26/2003 |
Request for comments on proposed information collection — Medical Device User Fee Cover Sheet; Form FDA 3601. (60-day notice.) Also see 5/21/2003 (submission to OMB) and 8/25/2003 (OMB approval). |
Comment period closed. (Comments were due by 4/28/2003.) |
|
2/25/2003 |
Medical Device User Fee Payment Procedures. | — |
|
2/10/2003 |
Request for comments on proposed information collection —MedWatch: The FDA Medical Products Reporting Program. (60-day notice.) Section 202 of MDUFMA directs FDA to modify MedWatch forms to facilitate the reporting of information pertaining to reprocessed single-use devices. Also see 4/29/2003 (submission to OMB) and 10/10/2003 (OMB approval). |
Comment period closed. (Comments were due by 4/11/2003.) |
|
2/4/2003 |
Establishment of a Public Docket. | Submit comments at any time. |
|
11/21/2002 | Establishment of Medical Device User Fee Rates for Fiscal Year 2003 and Interim Procedures. | 67 F.R. 70228 | — |
|
68 F.R. 1469 | — | |
|
68 F.R. 3033 | — |
Additional information —
A complete list of all of FDA’s MDUFMA guidance documents, including those
not announced in the Federal Register, is available at —
www.fda.gov/cdrh/mdufma/guidance
Each guidance document is available in plain text (html) and portable document format (pdf).
The latest version of this document is available at —
Text: www.fda.gov/cdrh/mdufma/mdufmafr.html
PDF: www.fda.gov/cdrh/mdufma/mdufmafr.pdf
Updated September 14, 2004
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