USFDA defines Test Plan for Digital Health Software Precertification (Pre-Cert) Program
The FDA is seeking test cases from software organizations planning to submit a De Novo Request or 510(k) submission for software as a medical device (SaMD) in 2019 or shortly thereafter to meet the goals of the Test Plan. The FDA’s request for test case submissions follows the rollout of the Pre-Cert program’s test plan earlier in 2019 establishing processes […]
FDA finalizes Class I classification for some medical device accessories
The US Food and Drug Administration has published a final rule that will go into effect from May 13, 2019, it includes a finalized list of accessories to be designated as low-risk Class I medical devices in accordance with the FDA Reauthorization Act of 2017 (FDARA). FDA have considered an accessory to be eligible for […]
US FDA plans closer evaluations of certain materials used to manufacture medical devices
US medical device regulators are planning more focused evaluations of materials used in the manufacture of medical devices for safety issues. According to a US FDA announcement, the agency acknowledges that despite current safety measures in place for certain implantable devices, “more work needs to be done” to address inflammatory reactions and other health conditions some […]
FDA issues final guidance on medical devices containing animal or animal-derived materials
The US Food and Drug Administration (FDA) has issued final guidance on medical devices containing materials derived from animal sources on March 15, 2019.The guidance is intended to help medical device companies establish and document procedures that mitigate risk of infectious disease exposure through contact with devices containing animal-derived materials. In the final guidance, the recommendations for […]
US FDA proposes more transparent process for managing requests for feedback on Form 483 observations
The US Food and Drug Administration plans to formalize processes for managing feedback requests received from medical device companies cited for deficiencies following establishment inspections, helping firms to determine adequate responses and corrective actions. The new draft guidance from the agency would set up a standardized process through which companies that have received FDA Inspectional Observation Form […]
CDSCO added eight medical device types to list of regulated devices
Central Drugs Standard Control Organization (CDSCO), Indiaexpands oversight to more types of medical devices, now planning to require registration for eight additional device types starting April 1, 2020. According to the new CDSCO notice, the following device types will require registration and import licensing under the Medical Device Rules, 2017: All implantable medical devices CT Scanning […]
US FDA finalizes Safety and Performance 510(k) registration route
FDA’s final guidance on what the agency calls its Safety and Performance Pathway is based on the Abbreviated 510(k) Program; FDA first announced plans to expand the Abbreviated 510(k) Program and published draft guidance in early 2018. Through this market authorization pathway, qualifying device manufacturers would be able to utilize performance criteria identified and approved by FDA to demonstrate […]
BSI-UK is designated as first Notified Body for the MDR
The British Notified Body BSI-UK is the first NB designated for the MDR, as can be seen in the European Database for Notified Bodies, NANDO. According to NANDO no NB has yet been designated for IVDs, but this may follow shortly. The designation covers all NBOG codes, and for all these codes BSI is designated for […]
US FDA issues a new rule that addresses post-market safety reporting obligations for combination products
USFDA has issued a final rule establishing the post-market safety reporting requirements specifically for combination products. These regulations for drugs, devices, and biological products share many similarities, however, each set of regulations has certain unique reporting requirements, standards and timeframes based in part on the characteristics of the type of product. The FDA’s new rule […]
ANVISA have introduced new clinical requirements for all novel medical device registrations and certain high-risk device
According to ANVISA’s recent announcement, the new clinical data requirements apply to qualifying devices submitted for review in both cadastro and registro registration routes. The key points from the technical notefor manufacturers are: Clinical data is now required for all novel devices. Some high-risk devices for which ANVISA determines safety and effectiveness may only be demonstrated via clinical […]
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