Premarket Submissions


 

Premarket submissions for many OTC products between the FDA and EU are as different as night and day.   For example, take the case of electromedical devices intended for hair removal.  In the USA, the device is Class II, and requires 510(k) clearance, with a comprehensive and conclusive clinical study according to USA demographics supporting label comprehension, usability and performance claims.  In the EU, a hair removal system is NOT a medical device – the definition of which is to “diagnose or treat a disease.”  How can these two markets be so different?  The US system is based on a regulation which went into effect in 1976, based on predicate (‘me-too’) products which are claimed to be substantially equivalent; the EU regulation in 1993 based on risk to the patient, but when the device is intended to diagnose or treat a disease.  This case illustrates how important it is for developers of OTC products to engage with a qualified consultant such as The CRO Group to “navigate the seas of OTC product regulation.”

The CRO Group has prepared and or assisted in the preparation of 510(k)s for hair regrowth, hair removal, temporary fat reduction, and in devices intended for obstructive sleep apnea for over 15 years.  And what’s more, The CRO Group knows when a product is NOT regulated as a medical device in the EU.  In the case of one hair removal device, The CRO Group prepared traditional 510(k) cleared in as little as 6 months.  While we cannot guarantee the same results for your product, when involved early on in development, The CRO Group is able to assist in design assurance to ensure smooth sailing in submissions

Manufacture Readiness


 

Often for OTC products, the 510(k) clearance is only ONE of the big hurdles.  Another may be manufacturing readiness in accordance with GMPs/QSR/Quality Systems.  Although many off-shore contract manufacturers are ISO 13485 certified, that does not mean they are QSR compliant.  The CRO Group includes consultants who are fluent in Chinese and experts in getting ISO 13485 certified contract manufacturers ready to comply with 21 CFR 820, the Quality System Regulation.