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
The FDA will be holding a public meeting on June 13, 2013 in order to discuss 510(k) modification submissions for medical devices. Specifically, the event serves as a sort of clearing house for the agency to present the history of 510(k) modifications, as well as to discuss present and future modification policy. Industry representatives are … continue reading
Bringing a medical device to market using clinical data acquired from an overseas trial could become more complicated in the near future if an FDA proposal becomes policy. In a bid to improve the quality of data that is being used to support 510(k) submissions, premarket approval applications (PMA), and investigational device exemptions (IDE), the … 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
Companies bringing a medical device to market in Egypt will need to familiarize themselves with recent changes being made by the Central Administration for Pharmaceutical Affairs (CAPA) to its regulatory standards. These alterations, which went into effect at the beginning of 2013, are designed to streamline the medical device approval process and make it easier … continue reading
In January 2013, new guidelines were issued by the European Commission that describe the European system for the notification and evaluation of Incidents and Field Safety Corrective Actions (FSCA) involving medical devices, known as the Medical Device Vigilance System. These guidelines cover the actions to be taken once the manufacturer or national competent authority receives information … continue reading
