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U.S. Department of Health and Human Services

Medical Devices

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Reprocessed Single-Use Device Timeline

Requirement Action Date

Action Needed by Reprocessors of Single-Use

Devices under MDUFMA

Guidance: Enforcement Priorities Guidance for SUDs Reprocessed by Third Parties and HopitalsGuidance Issued : August 14, 2000

All the regulatory requirements currently applicable to original equipment manufacturers, including premarket submission requirements (Sections 513 and 515 of the Act; 21 Code of Federal Regulations Parts 807 and 814).

Website: Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals

 

Medical Device User Fee Modernation Act (MDUFMA)Signed into law: October 26, 2002Website: Medical Device User Fee and Modernization Act (MDUFMA)

Federal Register Notice

[ Docket No. 03N-0161] Medical Devices; Reprocessed Single-Use Devices; Termination of Exemptions From Premarket Notification; Requirement for Submission of Validation Data  

ACTION: Notice.

 

Issued: April 30, 2003

FDA announced the availability of a list (List I) of critical reprocessed SUDs whose exemption from premarket submission was/is terminated and for which validation data, as specified under MDUFMA, was/is necessary in a 510(k); and a list (List II) of reprocessed SUDs that were currently subject to 510(k) requirements for which FDA determined that validation data, as specified under MDUFMA, was/is necessary in a 510(k).   DEADLINES: 

Manufacturers of SUDs identified in List I whose exemption was/is terminated were required to submit 510(k)s by July 30, 2004, or their devices could no longer be legally marketed.

Manufacturers who already had clearance letters for SUDs identified in List II were required to submit validation data for these devices by January 30, 2004, or marketing of these devices could no longer continue.

 

Federal Register Notice

[ Docket No. 03N-0161]   Medical Devices; Reprocessed Single-Use Devices; Termination of Exemptions From Premarket Notification; Requirement for Submission of Validation Data  

ACTION: Notice.

 

Issued: June 26, 2003

FDA Added nonelectric biopsy forceps (classified in 21 CFR 876.1075, Gastroenterology-urology biopsy instrument) to the list of critical reprocessed SUDs whose exemption from premarket notification requirements was/is terminated and for which validation data, as specified under MDUFMA, was/is necessary in a 510(k).

DEADLINE: 

Single-use biopsy forceps were required to submit 510(k)s for these devices by September 27, 2004, or their devices could no longer to be marketed

 

DEADLINE:

From April 30, 2003, Federal Register Notice

 

January 30, 2004Manufacturers who already had clearance letters for SUDs identified in List II (supplemental validation submissions (SVS)) had to submit validation data for these devices by January 30, 2004, or marketing of these devices could no longer continue.

Federal Register Notice

[ Docket No. 2004N-0154]   Medical Devices; Semicritical Reprocessed Single-Use Devices; Termination of Exemptions From Premarket Notification; Requirement for Submission of Validation Data  

ACTION: Notice.

 

April 13, 2004

FDA published a list of semicritical reprocessed SUDs whose exemption from premarket submission was/is terminated and for which validation data, as specified under MDUFMA, are necessary in a 510(k).

DEADLINE:

Manufacturers of reprocessed SUDs identified in the list whose exemptions were terminated were required to submit 510(k)s for these devices by July 13, 2005, or these devices could no longer able to be legally marketed.

 

DEADLINE:

From April 30, 2003, Federal Register Notice

 

July 30, 2004Manufacturers of SUDs identified in List I whose exemption was/is terminated were required to submit 510(k)s by July 30, 2004, or their devices were no longer to be marketed.

DEADLINE:

From June 26, 2003, Federal Register Notice

 

September 27, 2004Single-use biopsy forceps were required to submit 510(k)s for these devices by September 27, 2004, or their devices were no longer to be marketed

FDA DEADLINE:

FDA completed review of April 30, 2003, call for SVSs for certain device types.

 

November 1, 2004 

DEADLINE:

From April 13, 2004, Federal Register Notice

 

July 13, 2005Manufacturers of reprocessed SUDs identified in the list whose exemptions were terminated were required to submit 510(k)s for these devices by July 13, 2005, or these devices were no longer able to be legally marketed.

Federal Register Notice

[ Docket No. 2003N-0161] (formerly Docket No. 03N-0161)   Medical Devices; Reprocessed Single-Use Devices; Termination of Exemptions From Premarket Notification; Requirement for Submission of Validation Data   ACTION: Notice.

 

September 29, 2005

FDA added noncompression heart stabilizers to the list of critical reprocessed SUDs whose exemption from premarket notification requirements was/is terminated and for which validation data, as specified under MDUFMA, are necessary in a 510(k). The agency also added laparoscopic and endoscopic electrosurgical accessories to the list of reprocessed SUDs subject to premarket notification requirements that require submission of supplemental validation data.  

DEADLINES: Manufacturers of reprocessed single-use laparoscopic and endoscopic electrosurgical accessories who already have 510(k) clearance for these devices were required to submit supplemental validation data for the devices by June 29, 2006, or their devices were no longer legally marketed.  

Manufacturers of reprocessed single-use noncompression heart stabilizers must submit 510(k)s for these devices by December 29, 2006, or their devices may no longer be legally marketed.

 

DEADLINE:

From September 29, 2005, Federal Register Notice

 

June 29, 2006Manufacturers of reprocessed single-use laparoscopic and endoscopic electrosurgical accessories who already have 510(k) clearance for these devices were required to submit supplemental validation data by June 29, 2006, or their devices were considered no longer legally marketed.

DEADLINE:

From September 29, 2005, Federal Register Notice

 

December 29, 2006Manufacturers of reprocessed single-use noncompression heart stabilizers are required to submit 510(k)s for these devices by December 29, 2006, or their devices may no longer be legally marketed.