Dot Compliance

NOVEMBER 2, 2022

The FDA sends an FDA Form 483 Observation, also known as a “inspectional observation” or “Form 483” to draw attention to any potential legal infractions discovered during a routine inspection. These are issued after a 483 FDA inspection. Without FDA notification, companies may get this paper in the mail.

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Exeed Regulatory Compliance

APRIL 2, 2020

Market for interconnected medical devices is projected to grow but the regulatory pathway is still evolving. A new FDA guidance offers helpful recommendations for design and premarket submission. One way to understand how FDA is thinking about regulating these devices is to review recently cleared devices.

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Healthcare IT Today

JUNE 7, 2023

Many of our concerns center on the proposed implementation timeframes associated with various concepts included in HTI-1, as well as ONC’s failure to sufficiently consider the burden compliance will place on provider organizations and health IT developers. 31, 2024, compliance timeline is unrealistic.

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Exeed Regulatory Compliance

JULY 10, 2020

The FDA is consistently updating its Guidance and policy for various Face Masks, Face Shields and Respirators as new information becomes available. We recently discussed the FDA’s policy for Face Masks during COVID-19. So, there are two parts to the definition of these devices – what they are and how they are used.

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Dot Compliance

APRIL 12, 2022

Then we will provide general guidelines for producing labels that will benefit your customers and meet regulatory obligations. The FDA definition of a medical device is something that diagnoses, cures, treats, or prevents a disease or health condition, or otherwise alters the structure or function of the body. Source: [link].

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Healthcare IT Today

JANUARY 8, 2024

It is key for pharmaceutical companies to recognize that efficiency does not override compliance, patient safety or regulatory standards. While each company successfully gained FDA approvals, the current market acceptance for prescription digital therapeutics is low and improvements will take years.

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HIT Consultant

JULY 12, 2023

ICSRs don’t always provide enough detailed information for PV signal teams to draw a definitive conclusion about patient reactions to specific treatments. PV signal teams must balance growing workloads with maintaining regulatory compliance. ICSRs are inherently delayed.

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