Updated through Federal Register of September 9, 2004

Most-Recent Notices Listed First (Reverse Chronological Order)

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

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 8/20/2004)

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 9/1/2004)

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".                  

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".                         

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

Comment period closed.

(Comments were due by July 6, 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).

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).

Comment period closed.

(Comments were due by 11/10/2003.)

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).

Comment period closed.

(Comment were due by 11/7/2003.)

Notice of first Annual Stakeholder Meeting on Implementation of MDUFMA, to be held December 3, 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).

Availability of Draft Guidance — Premarket Assessment of Pediatric Medical Devices.

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

Comment period closed.

(Comments were due by 9/16/2003.)

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 8/7/2003.)

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).                   

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).

Comment period closed.

(Comments were due by 5/29/2003.)

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).

Comment period closed.

(Comments were due by 5/28/2003.)

Availability of Guidance — Implementation of the Inspection by Accredited Persons Program Under MDUFMA; Accreditation Criteria.

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

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 4/28/2003.)

Medical Device User Fee Payment Procedures.

Comment period closed.

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

Establishment of a Public Docket.

• 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.

• 1/22/2003 — Correction — Same intent.