The Affordable Care Act (ACA) takes its place as the major shaper of 2013 in Pricewaterhouse Cooper’s Health Research Institute’s (HRI) top 10 health industry issues . With 2014 as a significant deadline for changes in the industry due to expanded health coverage, 2013 will be a year to prepare for what is to come.
Regulatory and Compliance
The HHS Office of Inspector General (OIG) is renewing a prior recommendation that FDA require product sponsors to submit financial information on clinical investigators as part of the pretrial application process. It also wants the agency to develop a clear protocol for reviewing device adverse event reports that specifically address following up with manufacturers who routinely submit reports late or with incomplete information. The new OIG report says the two recommendations stem from similar ones previously made that FDA has failed to implement fully.
No one is debating the value of a unique device identification (UDI) system to manage medical devices. As Jim Dickinson notes in his column, most of the comments received by the agency on UDIs showed support for the project. 1 FDA is still in the process of collecting and reviewing those comments, although the comment period officially ended November 7 (FDA is still taking feedback).
In Part I and Part II of this series, we discussed the regulatory approval processes for medical devices in the US and in Europe. The markets in these countries are significant and are often given priority consideration when medical device companies form their overall regulatory strategies. However, developed and developing countries in Asia and Latin America are gaining increasing importance as emerging markets in the medical device arena.
A DC federal court has ruled that HHS properly withheld or redacted some documents relating to a suit brought by six current and former CDRH staffers through the National Whistleblower Center. In this latest phase in a Freedom of Information Act dispute between the whistleblowers and the department over access under “discovery” to records relating to the individuals’ employment, the department sought and received a partial summary judgment denying release of a specific subset of documents.
CDRH says it is puzzled by an increase in Class 1 medical device recalls over the past four years. Speaking to a Regulatory Affairs Professionals Society conference session in Seattle in October, CDRH Division of Risk Management Operations director Ann Ferriter said Class 1 recalls have increased from an average of 25 before 2008 to 50 and 57 such recalls in 2011 and 2012, respectively.
Have you allocated enough time and resources to ensure your medical device manufacturing efforts are compliant with the new global Restriction of Hazardous Substances (RoHS) law?
In 2003, the International Organization for Standardization (ISO) published the ISO 13485 standard, “Medical Devices—Quality Management Systems—Requirements for Regulatory Purposes.” ISO 13485:2003, which is based on ISO 9001:2000, was created to harmonize medical device regulatory requirements for quality management systems. The standard includes several requirements particular to medical devices and omits some of the requirements of ISO 9001. This list provides a sampling of registrars accredited to assess a company’s quality management systems and to issue a certificate confirming that the organization’s quality management system meets the requirements of ISO 13485.
Rita Hoffman is the managing partner RHoffman Inc. and has more than 36 years of FDA experience across the device, drug, and veterinary industries. Until recently, she served as recall branch chief for CDRH. She recently answered questions on building a recall strategy for medical devices. 1. What does “recall strategy” mean?
On August 2, 2012, FDA sent an open letter to the medical device industry advising the industry of significant changes to the establishment registration process. According to the agency, these changes are being driven by the FDA Safety and Innovation Act (FDASIA).
In August, we released the first segment in a series that addresses what engineers need to know about the medical device regulatory process from a design and development standpoint. In Part II of this series, we will look at the regulatory process in the United States. FDA Clearance and Approval To obtain FDA approval of a medical device, two main steps must be followed:
As medical device imports into the U.S. continue to grow at a 20% annual pace, CDRH believes it is making progress at last in its decades-long battle to get on top of the burgeoning foreign inspections the law requires it to do—it’s “outsourcing them” through its new Single Audit Program.
Political party platforms never seem to amount to much after their quadrennial national conventions labor mightily to produce them, and the one adopted by the Republican convention this year will doubtless follow that historical course as well. But at least it said something about FDA and medical device reform, which the Democrats’ counterpart did not.
Michael A. Santalucia is an independent regulatory affairs expert with more than 25 years experience in the medical device industry. We recently asked him to lay down the foundation of a regulatory strategy for medical device companies. Here are his definitions and advice for regulatory success. 1. What is a regulatory strategy?
Medical device companies have one primary goal: to develop, manufacture and market a medical device that addresses an unmet market need. While it’s a common goal, the medical device regulatory approval process can be confusing for design and development engineers. They may hear terms such as “safety agency,” “CE mark,” “Notified body,” “510K” and “PMA” tossed around by quality and regulatory professionals.