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FDA Introduces Pre-Cert Program For Reputed Companies

The Food and Drug Administration of United States which plays a critical role in safeguarding the health of its citizens also has to regulate usage of modern medical device and tools to improve healthcare services. The current fast paced innovations in the field of medicine to bring in new treatment methods and medicines has put the onus on FDA to study and approve these technologies at the earliest so that advantages of modern healthcare techniques are enjoyed by people. In fact, the agency’s commissioner Scott Gottlieb has emphasized on introducing a fast-paced procedure to get quicker approvals for medical techniques and medications.

Some of the latest programs adopted by FDA to enable faster approval are Pre-Cert Program, Genomics and CDS.

Pre-Cert Program was introduced in August 2017 to allow firms that enjoy reputation of being safe and responsible to go ahead and make products and devices without seeking approval for development of each new device by FDA. Around nine firms are now in this list that can develop products and processes to improve health. This list has brand leaders like Johnson & Johnson, Fitbit and Apple besides new players like Pear Therapeutics that is working on a kit to treat opium addiction.

FDA’s new ruling exempts established genomics companies that are working in consumer sector from conducting individual risk tests for their testing apparatus. Companies will now have to go through one-time review before marketing but they should refrain from false claims else they will be subject to agency sanctions.

CDS or Clinical Decision Support Tools will not be regulated under the new draft rule if they can be independently reviewed and understood by a doctor.

Based on Congressional mandates the agency has also made changes in the Cures Act under which it was stated that the FDA will not regulate for types of devices namely software for hospital administration, wellness software, EHR software and data related software.

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