FDA to help medical device sales with expanded pre-market feedback program
On the heels of the recently signed medical device user fee act (MDUFA), the Food and Drug Administration (FDA) is issuing suggested guidelines to give medical device makers feedback before they submit a product- or research-specific application.
The move comes as the agency is trying to strengthen its image regarding the safety of medical device and pharmaceutical products after facing criticism in the wake of a number of major recalls including Johnson and Johnson‘s DePuy hip replacement system and Boston Scientific‘s ICross catheters.
The new initiative expands on the existing pre-Investigational Device Exemption (pre-IDE) program, which does allow medical device companies to obtain feedback prior to the formal application process, but is intended to foster innovation by helping researchers identify regulatory requirements earlier in the development stage.
“No matter the regulatory pathway, FDA’s early feedback on studies can facilitate the development of a quality premarket submission and help industry avoid regulatory hurdles during the review process,” Christy Foreman, director of the Office of Device Evaluation in FDA’s Center for Devices and Radiological Health (CDRH), noted.
The program, which will now be referred to as the pre-submission or pre-sub program, may also help those with medical device sales jobs by getting safer products to market faster.
“FDA feedback to device developers early in the process can ultimately lead to more timely regulatory actions and innovative new devices for patients,” Dr. Alberto Gutierrez, director of CDRH’s Office of In Vitro Diagnostic Device Evaluation and Safety, added.
The draft guidelines are part of the FDA’s commitment in the newly approved MDUFA, which is designed to enhance the transparency and predictability of the CDRH’s pre-market notification 510(k) program. The newly signed law also doubles the user fee act that medical device manufacturers will have to pay the agency to review their products from $295 million to $595 million over the next five years. The legislation also includes the reauthorization of the prescription drug user fee act (PDUSA), which also increases the the amount pharmaceutical sales companies will have to pay the FDA.
According to the agency, the guidelines help advise medical device companies improve the effectiveness of pre-market submissions by describing when developers will benefit from FDA feedback and explain how best to engage the agency in informal meetings to discuss new technology or planned submissions.
Federal officials said they will now seek public comment on the draft before final approval.
- Press Announcements > FDA outlines plans to provide earlier feedback on device product submissions (earlsview.com)
- FDA to guide device makers on marketing application – chicagotribune.com (earlsview.com)
- Governmental Oversight of Potentially Dangerous Medical Devices – US Politics Today (earlsview.com)
- Smith & Nephew BHR FDA-required Post-Approval Studies (earlsview.com)
- New FDA guidance on considerations used in device approval (earlsview.com)
- Medical Device ” The Senate Passes Unparalleled Medical Device User Fee Act (earlsview.com)
- FDA Proposes Device ID Regulations for Medical Dev – TMD – Today’s Medical Developments (earlsview.com)
- FDA Proposes New Rule That Would Require Medical Devices Such as Surgical Mesh to Carry Unique Device Identifier (earlsview.com)
- Post-Approval Studies for Smith & Nephew BHR – NOT USEFUL (earlsview.com)
- New Proposed FDA System Will Give Potential AED.com Customers More Device Information Before Purchasing (prweb.com)