As per the paperwork reduction act of 1995 (the PRA), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice.
Under the section 210 of Food and Drug Administration Modernization Act (FDAMA), a 3rd party review program was started. As per the program, a private 3rd party wishing to participate has to be accredited by FDA and can review a manufacturer’s 510(k) submission for selected device. The 3rd party has to submit the documented review with recommendation to FDA and keep a copy himself for at least 3 years.
This information collection will allow FDA to continue to implement the accredited person review program established by FDAMA and improve the efficiency of 510(k) review for low- to moderate-risk devices. You can submit either electronic or written comments on the collection of information by “September 6, 2016.”
- Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper submissions):
Division of Dockets Management (HFA-305),
Food and Drug Administration,
5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
- Submit electronic comments in the following way:
Federal eRulemaking Portal. Follow the instructions for submitting comments
I For more information on the topic please visit Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Third-Party Review Under the Food and Drug Administration Modernization Act
? For any assistance with this compliance please contact us at firstname.lastname@example.org or use our Contact form, ref: Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Third-Party Review under the Food and Drug Administration Modernization Act