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Most of the provisions in the 21st Century Cures Act clarifying medical software regulation are straightforward and welcomed by industry, but it is unclear how the FDA will apply a provision on clinical decision support software. Read More
Every medical device imported into Malaysia for sale must have a single authorized representative, according to a new circular from the country’s Medical Device Authority. Read More
The FDA has had to postpone meetings with Capitol Hill staff to discuss upcoming user fee legislation, after the Trump administration directed agencies to halt correspondence with members of Congress. Read More
On the administration’s first full workday Monday, President Donald Trump froze federal hiring for most agencies, leaving the FDA with hundreds of job vacancies out of its workforce of approximately 15,000. Read More
Malaysia’s Medical Device Authority (MDA) has established an expedited review process for medical devices already approved in other jurisdictions including the U.S., Canada, Australia, the EU, and Japan. Read More
The FDA finalized guidance on GMP requirements for combination product manufacturers, adding scenarios to clarify how to comply with certain device requirements. Read More