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23andme.jpgOn November 22, 2013, 23andMe received a Warning Letter from FDA confirming that it had pursued the incorrect regulatory strategy regarding their Saliva Collection Kit and Personal Genome Service.  This letter was not simply an order to stop its practice of selling a product that they believed at one time not to be a medical device, a risk some companies might take, but a letter that communicated to the world that an independent 3rd Party, FDA, believed their product had no merit in diagnosing the potential disease state of patients.  This was a clear indictment as to the basic scientific integrity of their product.

This letter should not have been a surprise to the company.  It had been in clear communication with FDA for over four years.  In addition, in the previous 14 months they had submitted 510(k)s that were clearly being challenged as to the adequacy of the company’s verification/validation testing to support indications for use that had been expanding in the midst of this ongoing regulatory negotiation.

A less aggressive approach would have been to identify and support the scientific validity of the detection methodology and to identify the published literature that supported the relationship between the gene sequence and potential disease states.  However, to predict a probability of occurrence of the disease state was a bit beyond the objective evidence they had to support such claims.  Clearly, providing the patient with the existence of such a gene sequence would allow a patient to contact their health care physician for further discussions. 

It is not uncommon to find a client that needs guidance as to how aggressive a regulatory strategy can be.  It requires experience and knowledge to understand what objective evidence is available or needs to be generated to support a claim/intended use.  This strategy can include intermediate steps to allow commercial release while additional validation data is generated.  However, such a strategy requires patience and hard work.  Have you experienced such a challenge?  Share it with our readers.

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President/founder of RQMIS Inc. a consulting company with experience in the Medical Device/Biotechnology Industry focused on Regulatory/Clinical/Quality Affairs and Product Management.   RQMIS Inc. provides support in the areas of regulatory submissions (510k, IDE, PMA, HUD/HDE, Design Dossiers), Clinical Study Design/Management, Risk Management, Quality System Design/Audits (FDA QSR and ISO 13485) and FDA Negotiation and Communication (QSR Audits, 483s, Warning Letters, Bioresearch Monitoring, Medical Device Reports, Recalls).

Seven years experience as a Biomedical Engineer and Sr. Scientific Reviewer at FDA/CDRH/ODE and FDA’s Boston District.  This government experience was followed with seventeen (17) years in midlevel and executive management positions in small start-up and large multinational medical device companies.  Market responsibilities included United States (including Puerto Rico), European Union, South America, Canada, Japan and South Korea. 

Provides companies with regulatory and clinical strategic advice on bringing novel technologies to the United States and EU markets in the clinical fields of orthopaedics/neurosurgery/diabetic care (spine, restorative/reconstructive, sports medicine and wound healing), gastroenterology/urology/gynecology/pulmonology/cardiology/plastic surgery  (endoscopy/laparoscopy/minimally invasive/biliary stents).  The devices involved have included active implantables, long term implants, electromechanical, ultrasonic imaging and PACS products. 


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