FDA regulatory consultants and assistance

The Regulatory Education for Industry (REdI) Conference is an FDA-led forum that brings together the regulatory educators from FDA’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) to provide direct, relevant, and helpful information on the key aspects of drug and device regulations. The FDA holds these conferences only twice a year, which doesn't give medical device companies too much wiggle room when it comes to clearing their busy shedules to attend. So if you missed the conference, R&Q will fill you in!

Get the Presentations

The REdI Fall 2016 Conference was held Sept. 27 and 28 in Sheraton Silver Spring, Maryland, and covered FDA Insights on Products for Rare Diseases and Pediatrics, exploring issues which impact both drugs and devices. 

Topics included: 

CDER: Manufacturing Process Validation; Interactions with FDA; Emerging Technology and Inspection of NDA and BLA applications.
CDRH: 510(k); De Novo; Design Controls; and Complaints.

Here's more good news. The presentation slides and recordings for each session can be found here

Get Your Questions Answered

The conference's primary audience consisted of small manufacturers of drug/device medical products who were interested in learning how the FDA approaches the regulation of drugs and devices. Questions posed by these companies at the conference were very useful in understanding the type of questions real world clients may ask:

  • We are a design house and specification developer and hand off designs to the manufacturer, do we need to continue to list these devices?
  • We are an initial importer and our foreign manufacturer has asked that we file MDRs for them, can we?
  • Is there an electronic submission required for a recall?
  • We are a small company and the CEO performs many of the technical and quality functions, do we need to outsource our internalaudits?
  • We had our endotoxin testing defined in the 510(k) but now want to reduce testing, do we need to submit a new 510k? 

Here is more information on the REdI Fall 2016 Conference.

We are passionate about your success. Tell us more about your regulatory and quality needs so we can help.

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