Device Manufacturers Find an FDA Loop-Hole

Posted by Sarah Showard | Jan 05, 2016 | 0 Comments

A recent article posted in Forbes, informs readers that bringing new products to market can take years and require so much data proving product safety, that years can go by before consumers have the ability to purchase them.  To circumvent this the FDA has provided a "fast-track" for companies that promise to continue collecting market evidence of consumer safety.

A study conducted by JAMA, looked at 28 devices brought to market through the FDA Post Approval Studies (PAS) program in 2010 and 2011.  Findings indicate that post approval products often have very little data with fewer than 300 patients, in some cases, justifying a premature product release that may impact thousands of unsuspecting patients.

The question then becomes, "What's in a promise?"  The FDA has not imposed any type of penalty if manufacturers choose to conduct insignificant studies with fewer than 300 patients.  The years of data needed to prove product safety are not required when companies bring to market products through the PAS process.  

About the Author

Sarah Showard

Sarah Showard graduated from the University of Maryland in 1985, Magna Cum Laude with a Bachelor of Arts in English-Linguistics and a Certification in Womens Studies. She then graduated from New York University School of Law in 1988. Sarah began practice initially as an insurance defense attorne...


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