CDRH Industry: Announcing FDA Final Guidance and Webinar on “Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices”

Today the FDA published a final guidance, which provides a framework to consider extrapolating existing data to evaluate a device’s performance in pediatric patients in pre-market approval applications (PMAs), humanitarian device exemptions (HDEs) and de novorequests. This guidance facilitates continued efforts to address unmet medical device needs for pediatric patients. This guidance: explains the conditions in which […]

FDA Releases “Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies” Draft Guidance

Today we released the “Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies” draft guidance, which provides recommendations to improve the quality, consistency and transparency of data on how  medical devices perform within specific age, race, and ethnic groups.  Proper evaluation and reporting of this data can benefit patients, clinicians, […]

Announcing Final Guidance on Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” and FDA Webinar on the Final Guidance on July 21, 2016

Today we issued the final guidance document Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process.” This final guidance allows manufacturers to use the ISO 10993-1 standard when assessing the potential biological response of the medical devices and materials that come into direct […]

Consumer Information for Medical Devices Update: FDA Issues Draft Guidance on Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions

Today, the U.S. Food and Drug Administration released a draft guidance document, “Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions.” The purpose of this guidance is to clarify how the FDA assesses benefits and risks for medical devices already available on the market. This draft guidance focuses on the […]

FDA issues Final Rule: “Use of Symbols in Labeling” – Webinar July 25, 2016

Today the Food and Drug Administration (FDA) issued a final rule “Use of Symbols in Labeling” allowing the use of stand-alone symbols in medical device labeling, without adjacent explanatory text.  The final rule seeks to harmonize the labeling requirements of U.S. and international regulatory bodies with respect to the use of symbols in device labeling. This […]

FDA Implements Administrative Changes for Modular Premarket Approval Applications (PMAs); Effective June 13, 2016

Dear Modular PMA Holder: We are writing to inform you that effective June 13, 2016, FDA’s Center for Devices and Radiological Heath (CDRH) has implemented several process changes involving Modular PMAs.  These changes are the latest in a series of process changes regarding premarket submissions (previous changes involved premarket notifications (510(k)s), investigational device exemptions (IDEs), […]

Announcing Final Guidance on Postmarket Surveillance Under Section 522 of the Food, Drug, and Cosmetic Act and FDA Webinar on the Final Guidance on June 28, 2016

On May 16, 2016, we issued the final guidance document Postmarket Surveillance Under Section 522 of the Food, Drug, and Cosmetic Act.  Section 522 of the Federal, Food, Drug and Cosmetic Act (the Act) provides the FDA with the authority to require device manufacturers to conduct postmarket surveillance of certain class II or class III devices.  This […]

New eMDR Webpages Available to Help with Submissions

The FDA has added new information on our webpages about adverse event reporting requirements. The Electronic Medical Device Reporting (eMDR) System webpages help manufacturers, importers and health care facilities understand eMDR requirements and how to submit medical device reports electronically. On August 14, 2015, the eMDR final rule went into effect, requiring manufacturers and importers […]