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U.S. Department of Health and Human Services

Medical Devices

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Federal Register Notices Concerning MDUFMA

Updated through Federal Register of September 9, 2004

Most-Recent Notices Listed First (Reverse Chronological Order)

PDF Printer Version

 

Date Subject Citation Comment/Action Date
8/2/2004

Establishment of Medical Device User Fee Rates for Fiscal Year 2005.

 

69 F.R. 46153
7/9/2004

Agency Emergency Processing Under OMB Review; Application for Participation in the Medical Device Fellowship Program (Form FDA 3608).

 

69 F.R. 35277

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.

69 F.R. 31397

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 "User Fees and Refunds for Premarket Notification Submissions (510(k)s)" and "FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Performance Assessment".                  

69 F.R. 30672 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 "FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Performance Assessment".                         

69 F.R. 26868 Submit comments at any time.
5/7/2004

Proposed Rule — Definition of Primary Mode of Action for a Combination Product.

 

69 F.R. 24653

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).

69 F.R. 19433 Effective 4/13/2004; 510(k)s due 7/13/2005
2/17/2004 Announcing availability of revised MedWatch forms. 69 F.R. 7490 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).

68 F.R. 68632
11/26/2003 Availability of Guidance — Bundling Multiple Devices or Multiple Indications in a Single Submission. 68 F.R. 66463 Submit comments at any time.
11/24/2003 Availability of Guidance — User Fees and Refunds for Premarket Approval Application 68 F.R. 65940
11/3/2003 Availability of Guidance — Premarket Approval Modular Review. 68 F.R. 58690

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).

68 F.R. 58113

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.

 

68 F.R. 51788
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).

68 F.R. 45246
7/24/2003

Availability of Draft Guidance — Premarket Assessment of Pediatric Medical Devices.

Also see 5/14/2004 (availability of final guidance).

68 F.R. 42742

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).

68 F.R. 41160

Comment period closed.

(Comments were due by 8/7/2003.)

   •      7/23/2003 — Correction — Corrects OMB contact information. 68 F.R. 43534
    •     8/20/2003 — Correction — Corrects docket number. 68 F.R. 50155
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).                   

68 F.R. 40676 Submit comments at any time.
    •      7/23/2003 — Correction — Corrects docket number. 68 F.R. 43538
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).

68 F.R. 22716

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).

68 F.R. 22388

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.

                             

Also see 11/6/2003 (list of accredited persons).

68 F.R. 14992 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).

68 F.R. 8907

Comment period closed.

(Comments were due by 4/28/2003.)

2/25/2003

Medical Device User Fee Payment Procedures.

 

68 F.R. 6752

Comment period closed.

(Comments were due by 4/11/2003.)

2/4/2003

Establishment of a Public Docket.

 

68 F.R. 5643 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
  • 1/10/2003 — Correction — A 510(k) submitted during FY 2003 is not eligible for a reduced small business fee. Fee for any 510(k) submitted during FY 2003 is $2,187.
68 F.R. 1469
  • 1/22/2003 — Correction — Same intent.
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 the MDUFMA Guidances web page.

Each guidance document is available in plain text (html) and portable document format (pdf).