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 The new draft guidance from the agency would set up a standardized process through which companies that have received FDA Inspectional Observation Form […]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on the Abbreviated 510(k) Program; FDA first announced plans to expand the Abbreviated 510(k) Program and published draft guidance in early 2018.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 […]
Sankranthi Lunch @ Stark, NJ
Stark Associates Team celebrated the Sankranthi Festival at workplace. Food is very important to any Indian Festival We all employees brought various food items for lunch, Like a potluck. (Biryani, Mirchi Bajji, Roti, Chicken, Sweets). We celebrated this festival in a totally traditional way. And yes it was yummy.
Stark Associates Exhibits at DIA 2018, June 24-28 in Boston, MA
Stark Associates has been successfully providing Clinical Research services, providing high level technical and functional Clinical operations, Drug Safety, Regulatory Affairs and Validation services to large, mid-sized and small Pharmaceutical, Biotech and Life Sciences companies throughout the USA. This will be Stark Associates first year exhibiting at the Drug Information Association (DIA) Annual conference to continue supporting their growing […]
Making presence felt – Stark Associates at DIA 2018, Boston.
And it’s a wrap! Stark Associates had a great time interacting with clients and business partners. We got great new leads to our near future prospects. We want to take a moment thank every client and business partner who took time to stop by our booth and interacted with our Client Services Representative, Madhukiran Parvathaneni. […]
Behind the scenes putting up Stark’s booth at DIA 2018, Boston
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 […]
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