Guidance: Enforcement Priorities Guidance for SUDs Reprocessed by Third Parties and Hopitals

Guidance 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: www.fda.gov/cdrh/reuse/1168.html

Medical Device User Fee Modernation Act (MDUFMA)

Signed into law: October 26, 2002

Website: www.fda.gov/oc/mdufma/

Federal Register Notice

ACTION: Notice.

Issued: April 30, 2003

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

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).

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, 2004

Manufacturers 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

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, 2004

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 were no longer to be marketed.

DEADLINE:

From June 26, 2003, Federal Register Notice

September 27, 2004

Single-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, 2005

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 were no longer able to be legally marketed.

Federal Register 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, 2006

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 by June 29, 2006, or their devices were considered no longer legally marketed.

DEADLINE:

From September 29, 2005, Federal Register Notice

December 29, 2006

Manufacturers 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.