The medical device community found itself facing unusual circumstances – essentially unprecedented – this March when the FDA was told by a House Representative that it could potentially lose its ability to regulate medical devices. The threat, which came from Tennessee Rep. Marsha Blackburn (R), was grounded in the intricacies of the Patient Protection and … continue reading
The upcoming transition to the Third Edition of the IEC 60601-1 standard for electrical medical devices is fast approaching. June 30, 2013 represents the deadline for meeting the requirements of this new standard, which affects all medical device companies producing products that make use of electricity or electrical systems. The International Electrotechnical Commission (IEC) has … continue reading
The term ‘sequestration’ has been bandied about by the media for well over a month, and medical device manufacturers should be aware that the economic consequences of this particular government policy are not limited to selected federal agencies but apply across the board. Sequestration could eventually end up affecting the FDA – as well as … continue reading
Communication is a key aspect of bringing a medical device to market, particularly when it comes to successfully completing the paperwork associated with pre and postmarket submissions. The FDA has long pointed to incomplete or low-quality submissions as a reason for slowdowns associated with the clearance/approval of new products, and has issued a new draft … continue reading
It would seem to make sense that cooperation between drug and medical device manufacturers could lead to enhanced efficiencies for the FDA. A harmonization effort, designed to marry the electronic submissions for both medical devices and drugs, is currently underway. This challenging task has been picked up by the International Medical Device Regulator’s Forum (IMDRF), … continue reading
Will medical device companies be looking at major changes to the National Competent Authorities Report (NCAR) program in the near future? NCAR was originally established 20 years ago in order to help facilitate the sharing of information concerning serious adverse events associated with medical devices in a confidential manner. Specifically, NCAR is used by a … continue reading
Re-registration of a medical device in the Chinese market should become easier in the near future, thanks to efforts being made by the China Food and Drug Administration to simplify the current re-registration process. Currently, medical device manufacturers must re-register within six months of the expiration of a product’s original registration certificate. The move is … continue reading
Designing and analyzing clinical studies for pediatric devices and for medical devices that treat or diagnose a rare disease or condition brings unique challenges for clinical researchers. For pediatric devices, sponsors need to consider patient size and body structure, level of activity, duration of use, device longevity, and long-term exposure to implanted materials. For rare … continue reading
Medical device companies are beginning to enjoy some of the benefits of the FDA and CDRH transparency and efficiency initiatives. A recent story at Today’s Medical Developments reports that 510(k) premarket notification review times grew shorter in 2011, fighting against a trend that had seen manufacturers waiting longer and longer for an official response to … continue reading
Could a public-private partnership be an effective tool for improving the speed with which the FDA is able to review medical device 510(k) applications? The Agency is counting on the answer to this question being ‘yes,’ with the announcement that it will be collaborating with LifeScience Alley in the Medical Device Innovation Consortium (MDIC), a … continue reading
