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  StarFish analysis: Medical device accessory guidance

  FDA medical device accessory guidance lessens regulatory burden, permitting low risk devices to market faster and cheaper.

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  Great News for manufacturers of Medical Device Accessories and products intended for general wellness!

  Overview analysis of the FDA’s 2019 guidance on low-risk devices for general wellness and medical device accessories.

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  Faster Market Access for Less: Medical Device Single Audit Program (MDSAP)

  MDSAP enables Medical Device companies to save in Registrar’s fees, eliminate duplication of inspections and gain faster access to markets.

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  Benefits of Positive On-Site Inspection for Medical Device Development Companies

  Preparation for our medical device development and contract manufacturer On-Site inspection helped our client earn a successful Factory Inspection.

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  FDA Recognized Standards List Number 30 for Medical Devices

  Updated FDA Recognized Standards for use in premarket reviews of medical devices with declaration of conformity to consensus standards.

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  FDA Guidance on eCopy Program for Medical Device Submissions

  eCopy or electronic Submission Template And Resource (eSTAR) premarket submissions online through the CDRH Customer Collaboration Portal.

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  Proposed EU Medical Device Regulations (2012)

  Proposed EU Medical Device Regulations (2012) replace current Directives with two Regulations; one for medical devices and the other for IVDD

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  US Medical Device Tax- Good or bad for the industry?

  Article with update links on 2012 US Medical Device Tax in the US and blogs with controversial views of the tax impact on the industry.

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  Date Format Quandary for FDA UDI for Medical Devices

  Why is the ISO 8601 standard not used for the date format (i.e. 2012/07/02) for FDA UDI instead of the proposed format (i.e. Jul 02, 2012)?

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