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FDA Released the 2016 Plan of Guidance for Medical Devices

Source:   Time:2016-09-28


FDA issued the Year 2016 Plan of Guidance for Medical Devices

As can be seen from the list, the topics FDA frequently mentioned last year, such as  Unique Device Identification (UDI), medical device report (MDR) program, will be written in the guidance documents, providing specific requirements and operational guidelines to manufacturers and FDA officials .

Human factors engineering, Usability engineering , aseptic validation and biological evaluation, which are widely applied in medical apparatus and instruments , will be summarized as a subject and published in a final version.

In addition, blood glucose testing products are of particular concern by FDA. In  near future, evaluation scales for such products will be strict according to FDA .

Osmumda will promptly notify FDA guidance issuing status, and manufacturers who are on the American market are advised to keep an eye on the guidance.

Priority Medical devices guidance,the one CDRH plan to release in 2016 fiscal year (list A):

Final Guidance Topics

● General health products

● Medical devices accessories

●Risk and return that should be considered when apply for Review of clinical medical device exemption (IDE)

● Direct identification of UDI

Adaptability design for medical device clinical research

● Consider Patient’s preference in pre-market approval, Humanitarian device exemption(HDE) ,re-classification and definition

● Optimize designs of medical devices with application of human factors engineering and usability engineering

● Supervised policy for laboratory self-build reagent

● Information submitted and examine for identified sterile devices

● ISO 10993-1:Part 1 of medical devices biological evaluation: evaluation and test for application of biocompatibility

● Research on post market supervision according to  Federal food, drug, and Cosmetic Act chapter 522

● Medical Devices Report formality for manufacturer

Draft Guidance Topics

● Decision support software for medical devices

● Application of identification in label

● 510(k) Modify

● Software Modify

● 510(k) third party audit procedure

● Joint development of diagnostic products

● Using real patient observation data to support decision making in medical devices

● Unique Device Identification

● Announcement of unexpected events against post market medical devices

(under the conditions of writing source allowance) Medical devices guidance,the one CDRH plan to release in 2016 fiscal year (list B):

Final Guidance Topics

●Computer modeling study report in medical apparatus and instruments submitted files

● Prescription class bed used blood glucose monitoring and inspection system

● Over-the-counter class type self-test glucose meter

● Radiation dose equipment

● Finalized Existing Draft Guidance

Draft Guidance Topics

● Medical apparatus and instruments interactive operation

●  Access for patients to get information

● Medical device clinical study evaluation and report against statistics of age, race and ethnic

●  individual equipment for orthopaedic surgery patients

● Synchronized apply for both 510(k) and Clinical Laboratory Improvement Amendments(CLIA) exemption

● Determined UDI

● key quality information of instruments and patches used for abdominal surgery

● key quality information of equipment using hydrophilic or hydrophobic covered blood vessels and nerves system