Regulatory Affairs Syndicator

CDRH is taking steps to increase its ability to identify, analyze, and act on postmarket information in order to improve the safety and effectiveness of medical devices and radiation-emitting products.

After a thorough review of its postmarket processes, CDRH recently published two documents - "Ensuring the Safety of Marketed Medical Devices: CDRH?s Medical Device Postmarket Safety Framework" and "Ensuring the Safety of Marketed Medical D

These are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for August 2006.

Questions and Answers about the Postmarket Transformation Initiative.

The FDA is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The FDA is announcing an opportunity for public comment on the proposed collection of certain information by the agency.

The FDA is Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002

The FDA is announcing a publication containing modifications the agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA recognized consensus standards)

PDF format only. Topics: Annual Reports, Office of Device Evaluation (ODE)

Topics: Annual Reports, Office of Device Evaluation (ODE)

In April 1999, the FDA in partnership with representatives from the hospital bed industry, national healthcare organizations, patient advocacy groups and other federal agencies formed the Hospital Bed Safety Workgroup. The workgroup?s goal is to improve..

This draft guidance document was developed as a special control guidance to support the reclassification of the absorbable hemostatic device into class II (special controls). The device, as proposed, is intended to be implanted during surgical procedure..

This Halloween season, the U.S. Food and Drug Administration (FDA) is again warning consumers about the serious risks of using decorative contact lenses without the appropriate involvement of an eye care professional.

In the Federal Register of August 16, 2005 (70 FR 48157), FDA announced that a proposed collection of information entitled “MedWatch: Food and Drug Administration Medical Products Reporting Program’ had been submitted to OMB for approval under the PRA.