genetic risk – media

FDA to Omit 501(k) Premarket Approval for Genetic Risk Tests

Today the FDA will officially exempt individual genetic risk tests from 501(k) premarket approval with the condition that the company offering the test should have a one-time premarket review of its testing apparatus and at least one test.
- Source: MobiHealthNews
- 715
- June 5, 2018
FDA genetic risk Market Views
FDA Announces New Policy for Genetic Testing Regulation

In another example of the FDA's revision of regulatory policies for digital health products, Commissioner Scott Gottlieb announced on Nov. 6, 2017, that the agency is extending its precertification model to low-risk direct-to-consumer genetic risk tests.
- Source: jdsupra
- 529
- November 10, 2017
direct-to-consumer genetic risk Policy
Scientists pinpoint genetic risk factors for asthma, hay fever and eczema

A major international study has pinpointed more than 100 genetic risk factors that explain why some people suffer from asthma, hay fever and eczema.
- Source: Medicalxpress
- 493
- November 1, 2017
asthma eczema genetic risk hay fever Researches

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