Metal-on-Metal Hip Implants: FDA Proposes to Require Premarket Approval
On January 18, 2012, FDA issued a proposed order that would require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for...
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Wireless Medical Device Law and Regulation Takes Center Stage at FCC, FDA,...
Wireless medical devices stand at an innovative crossroad between health care, communications, and technology law and regulation. Many of the health and safety aspects of such devices are regulated by...
View ArticleFDA Releases Final Guidance Relating to Humanitarian Device Exemptions (HDE)
On January 24, 2013, FDA issued its final guidance on humanitarian use device (HUD) designation requests. In a Federal Register notice posted on the same day, the agency explained that this final...
View ArticleRegulatory Developments on the Horizon for Personalized Medicine
Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health at FDA, recently described the regulatory environment for personalized medicine as “chaotic,” noting the need...
View ArticleMedical Product Promotion in the Age of Social Media
Will 2013 be the year FDA provides comprehensive guidance on the use of social media to promote regulated medical products? It has been more than three years since FDA held a public hearing on the use...
View ArticleFDA Issues Draft Guidance on Device Recalls, Enhancements, and Part 806...
Last week, the Center for Devices and Radiological Health (CDRH) issued a draft guidance, “Distinguishing Medical Device Recalls from Product Enhancements and Associated Reporting Requirements,” that...
View ArticleProposed FDA Rule Requires “Good Clinical Practice” in Foreign Device Studies...
On February 25, 2013, FDA issued a proposed rule incorporating the principles of “Good Clinical Practice” (“GCP”) into the requirements for FDA acceptance of data from clinical studies conducted...
View ArticleCongress Shows Continued Interest In Mobile Medical Apps
Congress seems to agree that one of the most interesting issues in device law right now is FDA’s ongoing attempt to develop a regulatory framework for mobile apps that meet the statutory definition of...
View ArticleCongress to Hold Hearings on FDA Regulation of Mobile Medical Apps and Impact...
On March 19, 20 and 21, 2013, the Energy and Commerce Committee of the U.S. House of Representatives will hold a series of three hearings on “Health Information Technology to Explore Potential...
View ArticleSummary of 2012 FDA Promotional Enforcement Activity
In 2012, the Office of Compliance at CDRH issued 15 warning letters relating to the promotion of approved or cleared medical devices, a significant increase from both 2011 and 2010. CDRH’s letters...
View ArticleFDA Tells Congress to Expect Final Guidance on Mobile Medical Apps This Year
As we have reported previously, the regulation of mobile medical apps continues to be an issue on Congress’ radar. Last week, the Republican-led House of Representatives Energy and Commerce Committee...
View ArticleCytori v. FDA: D.C. Circuit Upholds FDA’s NSE Decisions
Stating that it was “ill-equipped to second-guess” FDA’s scientific judgments, the D.C. Circuit Court of Appeals recently upheld FDA’s determination that two medical devices were not substantially...
View ArticleFDA Finalizes Guidance on Financial Disclosures by Clinical Investigators
FDA issued a final guidance on disclosure of financial interests of clinical investigators. FDA intends for the guidance to assist clinical investigators, clinical trial sponsors, and applicants in...
View ArticleChallenging Issues Confronting Companion Diagnostics Transactions – Part 1
Overview The market for companion diagnostics has been growing steadily for a number of years, with some sources estimating that global companion diagnostics market will reach $19.3 billion by 2023....
View ArticleFDA Plans to Complete Classifications of Preamendment Devices by the End of 2014
Last month, FDA announced that it plans to complete classification actions for remaining preamendments devices by the end of 2014. These actions could take the form of orders requiring the filing of...
View ArticleFDA Issues Draft Guidance on Molecular Diagnostic Instruments with “Combined...
On April 9, 2013, FDA published a Federal Register notice announcing a new draft guidance on molecular diagnostic instruments with “combined functions” — i.e., combining functions subject to FDA...
View ArticleD.C. District Court Rules FDA has Inherent Authority to Rescind 510(k)...
In a closely watched case, Ivy Sports Medicine v. Sebelius, et al., the United States District Court for the District of Columbia recently upheld FDA’s rescission of the clearance of ReGen Biologic’s...
View ArticleCDRH Releases Updated Plan to Strengthen Postmarket Surveillance of Medical...
On April 23rd, FDA’s Center for Devices and Radiological Health (CDRH) released a report entitled “Strengthening Our National System for Medical Device Postmarket Surveillance: Updates and Next Steps.”...
View ArticleGrowth in the Wearable Sensor Market Puts New Focus on Difficult Regulatory...
Big news came out of the digital health industry this week, when Jawbone announced that it would acquire BodyMedia, reportedly for more than $100 million. Both companies market products in a rapidly...
View ArticleFDA Announces Public Workshop to Discuss When a 510(k) Should be Submitted...
FDA recently announced a public meeting to be held on June 13, 2013 on when a new 510(k) must be submitted for a modification to a cleared device. The meeting is intended to solicit stakeholder input...
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